glycomark compendium of evidence

54
GlycoMark Compendium of Evidence The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected]. Glycemic Control No. Title Institute Department First Author Citation 1 Variations of 1-Deoxyglucose (1,5-Anhydroglucitol) content in patients with insulin-dependent diabetes mellitus National Defense Medical College Pediatrics Yoshioka S Clin.Chem 1983; 29(7): 1396-1398 2 Reduction and recovery of plasma 1,5-anhydro-D-glucitol level in diabetes mellitus University of Teikyo Internal Medicine Yamanouchi T Diabetes 1987; 36(6): 709-715 3 Reduction of plasma 1,5-AG(1,5-Anhydroglucitol) levels in diabetes mellitus and renal glycosuria Saitama Medical School Internal Medicine Kawazu S J. Japan Diab. Soc. 1988; 31(8): 715-718 4 Urinary excretion of 1,5-Anhydro-D-glucitol accompanying glucose excretion in diabetic patients Institute for Diabetes Care and Research, Asahi Life Foundation Akanuma Y Diabetologia 1988; 31: 831-835 5 Reduction of plasma 1,5-anhydroglucitol concentration in diabetic patients University of Teikyo Internal Medicine Yamanouchi T Diabetologia 1988; 31:41-45 6 Plasma 1,5-anhydro-D-glucitol as new clinical marker of glycemic control in NIDDM patients University of Teikyo Internal Medicine Yamanouchi T Diabetes 1989; 38(6): 723-729 7 Clinical significance of serum 1,5-anhydroglucitol measurements in diabetes mellitus University of Teikyo Internal Medicine Yamanouchi T J. Japan Diab. Soc. 1990; 33(1): 41-48 8 Serum 1,5-Anhydroglucitol level in patients with non- insulin-dependent diabetes Mellitus Jichi Medical School Endocrinology and Metabolism Iwamoto Y Korea Japan Symp.D.M. 1991; 117-120 9 1,5-anhydroglucitol as a marker of glycemic control in diabetes mellitus. - Its correlation with fasting plasma glucose at present or 2 weeks before - Jichi Medical School Endocrinology and Metabolism Ohwada N Clinical Endocrinology 1991; 39(2): 159-161 10 Serum 1,5-anhydro-D-glucitol and glycemic control in patients with non-insulin-dependent diabetes mellitus Kyushu University Internal Medicine Umeda F Tohoku J.Exp Med 1991; 163: 93- 100 11 Plasma 1,5-anhydroglucitol level in diabetes mellitus* Toyama Red Cross Hospital Internal Medicine Hiraiwa Y Medical Journal of Toyama 1058, 22-27, 1991 12 Comparison of 1,5-Anhydroglucitol with several metabolic parameters in the treatment of Diabetes Mellitus Saiseikai Central Hospital Internal Medicine Suzuki Y Jpn J Med Pharm Sci. 1992; 27(3): 643-647 13 Measurement of serum 1,5-anhydroglucitol in patients with "near-normal" hyperglycemia Shinshu University School of Medicine Internal Medicine Komiya I J. Japan Diab. Soc. 1992; 35(5): 385-389 14 Clinical usefulness of 1,5-anhydroglucitol in Diabetes mellitus - Utility of 1,5-anhydroglucitol as a glycemic marker in initial treatment of diabetes mellitus* Ota Nishinouchi Hospital Diabetes Center Ota S Practice 1992; 9(2): 168-171 15 Estimation of Plasma Glucose Fluctuation with a Combination Test of Hemoglobin A1c and 1,5- Anhydroglucitol University of Teikyo Internal Medicine Yamanouchi T Metabolism 1992; 41(8): 862-867 1 M-7-3A (2017-10-18)

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Page 1: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Glycemic Control

No. Title Institute Department First Author Citation 1 Variations of 1-Deoxyglucose (1,5-Anhydroglucitol)

content in patients with insulin-dependent diabetes mellitus

National Defense Medical College

Pediatrics Yoshioka S Clin.Chem 1983; 29(7): 1396-1398

2 Reduction and recovery of plasma 1,5-anhydro-D-glucitol level in diabetes mellitus

University of Teikyo Internal Medicine Yamanouchi T Diabetes 1987; 36(6): 709-715

3 Reduction of plasma 1,5-AG(1,5-Anhydroglucitol) levels in diabetes mellitus and renal glycosuria

Saitama Medical School

Internal Medicine Kawazu S J. Japan Diab. Soc. 1988; 31(8): 715-718

4 Urinary excretion of 1,5-Anhydro-D-glucitol accompanying glucose excretion in diabetic patients

Institute for Diabetes Care and Research, Asahi Life Foundation

Akanuma Y Diabetologia 1988; 31: 831-835

5 Reduction of plasma 1,5-anhydroglucitol concentration in diabetic patients

University of Teikyo Internal Medicine Yamanouchi T Diabetologia 1988; 31:41-45

6 Plasma 1,5-anhydro-D-glucitol as new clinical marker of glycemic control in NIDDM patients

University of Teikyo Internal Medicine Yamanouchi T Diabetes 1989; 38(6): 723-729

7 Clinical significance of serum 1,5-anhydroglucitol measurements in diabetes mellitus

University of Teikyo Internal Medicine Yamanouchi T J. Japan Diab. Soc. 1990; 33(1): 41-48

8 Serum 1,5-Anhydroglucitol level in patients with non-insulin-dependent diabetes Mellitus

Jichi Medical School Endocrinology and Metabolism

Iwamoto Y Korea Japan Symp.D.M. 1991; 117-120

9 1,5-anhydroglucitol as a marker of glycemic control in diabetes mellitus. - Its correlation with fasting plasma glucose at present or 2 weeks before -

Jichi Medical School Endocrinology and Metabolism

Ohwada N Clinical Endocrinology 1991; 39(2): 159-161

10 Serum 1,5-anhydro-D-glucitol and glycemic control in patients with non-insulin-dependent diabetes mellitus

Kyushu University Internal Medicine Umeda F Tohoku J.Exp Med 1991; 163: 93-100

11 Plasma 1,5-anhydroglucitol level in diabetes mellitus* Toyama Red Cross Hospital

Internal Medicine Hiraiwa Y Medical Journal of Toyama 1058, 22-27, 1991

12 Comparison of 1,5-Anhydroglucitol with several metabolic parameters in the treatment of Diabetes Mellitus

Saiseikai Central Hospital

Internal Medicine Suzuki Y Jpn J Med Pharm Sci. 1992; 27(3): 643-647

13 Measurement of serum 1,5-anhydroglucitol in patients with "near-normal" hyperglycemia

Shinshu University School of Medicine

Internal Medicine Komiya I J. Japan Diab. Soc. 1992; 35(5): 385-389

14 Clinical usefulness of 1,5-anhydroglucitol in Diabetes mellitus - Utility of 1,5-anhydroglucitol as a glycemic marker in initial treatment of diabetes mellitus*

Ota Nishinouchi Hospital

Diabetes Center Ota S Practice 1992; 9(2): 168-171

15 Estimation of Plasma Glucose Fluctuation with a Combination Test of Hemoglobin A1c and 1,5-Anhydroglucitol

University of Teikyo Internal Medicine Yamanouchi T Metabolism 1992; 41(8): 862-867

1 M-7-3A

(2017-10-18)

Page 2: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 16 Clinical usefulness of 1,5-anhydroglucitol in assessing

treatment effect in insulin treatment for NIDDM* Toshima Hospital Internal Medicine Aiso Y Practice 1992; 9(6): 543-546

17 Clinical usefulness of the combination of HbA1c, fructosamine and 1,5-anhydro-D-glucitol as the indices of glucose control of diabetes mellitus

Saiseikai Central Hospital

Internal Medicine Hosokawa K Clinic All Round 1992; 41(9): 2536-2539

18 Clinical significance of serum 1,5-anhydro-D-glucitol measurements in diabetes mellitus

Oita Medical University

Internal Medicine Ito Y Jpn J Med Pharm Sci. 1992; 28(6): 1307-1314

19 Clinical significance of measurement of serum 1,5-anhydroglucitol in diabetes mellitus - Especially relation to nephropathy -

Hyogo College of Medicine

Clinical Pathology and Clinical Laboratories

Fujiwara K Medical Consultation and New Remedies 1993; 30(1): 125-133

20 1,5-anhydroglucitol, a novel glycemic control marker for diabetes mellitus*

Kanda Internal Medicine Clinic

Kanda M Medical Journal of Yamanashi 1992; 20:128-132

21 Evaluation of 1,5-AG determination as new marker of glycemic control

Yokufukai Geriatric Hospital

Central Clinical Laboratory

Takamatsu N Japanese Journal of Medical Technology 1993; 42(5): 961-966

22 Changes in plasma and urinary concentrations of 1,5-anhydro-D-glucitol during oral glucose tolerance test

The Institute for Diabetes Care and Research, Asahi Life Foundation

Yoshioka N J. Japan Diab. Soc. 1993; 36(11): 839-845

23 Clinical significance of serum 1,5-anhydroglucitol level in diabetic patients: A study of glucose and calcium metabolism

Osaka Prefectural General Hospital

Gastroenterology and Metabolism

Kanda T Medical Journal of Osaka Prefectural General Hospital 1993; 16(1): 16-20

24 Clinical significance of measurement of serum 1,5-anhydroglucitol*

Kinki University Internal Medicine Kishitani Y New Horizon for Medicine 1994; 26(extra I): 884-890

25 Clinical study on changes in 1,5-anhydroglucitol concentration in plasma

Teramoto Memorial Hospital

Internal Medicine Yoshikawa T Journal of Clinical Laboratory Medicine 1994; 38: 485-488

26 Variations of free non-glucose polyols in serum from patients with diabetes mellitus and their correlation with hemoglobin A1c

National Defense Medical College

Pediatrics Yoshioka S J. Natl. Def. Med. Coll 1990; 15(4): 217-223

27 Clinical usefulness of 1,5-anhydroglucitol for evaluating efficacy of treatment in non-insulin dependent diabetes mellitus. - Especially early marker reflected improvement of glycemic control - *

Kyoto Second Red Cross Hospital

Internal Medicine Okajima Y Medical Consultation & New Remedies 1994; 31(6): 1073-1078

28 Effect of aging on plasma 1,5-anhydroglucitol levels in humans and rats

Wakayama Medical College Kihoku Hospital

Internal Medicine Funasako M Diabetes Res. Clin. Pract. 1994; 25: 35-41

29 Clinical evaluation of serum 1,5AG levels in Diabetics National Kyushu Cancer Center

Gastroenterology Wakasugi H Japanese Journal of National Medical Services 1994; 48(1): 32-35

2 M-7-3A

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Page 3: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 30 Significance of 1,5-anhydro-D-glucitol in diabetes mellitus

management Keio University Preventive Medicine and

Public Health Shimada N Jpn J Ind Health 1993; 36: 448-449

31 The clinical study of the diabetic marker (Centering around 1,5-AG)

Tokyo Kosei-Nenkin Hospital

Central Laboratory Yonekubo I Annual bulletin of Kosei-Nenkin Hospitals 1993; 20: 381-389

32 1,5-Anhydro-D-glucitol Evaluates daily glycemic excursions in well-controlled NIDDM

Osaka University Internal Medicine Kishimoto M Diabetes Care 1995; 18(8): 1156-1159

33 Significance of combination with acarbose in poorly controlled non-insulin dependent diabetes mellitus without obese in sulfonylurea therapy*

Osaka Prefectural General Hospital

Gastroenterology and Metabolism

Kanda T J. New Rem. & Clin. 1995; 44(10): 1699-1705

34 The significance of serum 1,5AG level in outpatients of non-insulin dependent diabetes mellitus

Tokyo Medical College

Internal Medicine Notoya Y J. Tokyo Med. Univ 1995; 53(6): 842-846

35 Plasma 1,5-anhydroglucitol as clinical marker of diabetic control

Wu D The Medical Journal of Niigata City General Hospital 1994; 15(1):13-20

36 Clinical usefulness of serum 1,5-anhydroglucitol in monitoring glycaemic control

University of Teikyo Internal Medicine Yamanouchi T THE LANCET 1996; 347: 1514-1518

37 Efficacy of combination treatment of α-glucosidase inhibitor and sulfonylurea in elder diabetic patients*

Tokyo Medical University Hachioji Medical Center

Endocrinology and Metabolism

Ohno A J. New Rem. & Clin. 1996; 45(6): 1129-1135

38 Clinical effectiveness of long-term administration of BAY g 5421 (Acarbose) on insulin-treated diabetes

Osaka University Internal Medicine Kawamori R Jpn Pharmacol Ther 1996; 24(5): 1109-1129

39 The long-term clinical trial for the evaluation of BAY g 5421 (Acarbose) combined with sulfonylurea in patients with NIDDM

Tohoku University School of Medicine

Internal Medicine Toyota T Jpn Pharmacol Ther 1996; 24(6): 1375-1392

40 Beneficial effect of an α-glucosidase inhibitor combined with conventional insulin therapy in non-insulin-dependent diabetics

Gracia Hospital Internal Medicine Watanabe N J. Japan Diab. Soc. 1996; 39(9): 679-686

41 Effect of acarbose on blood glucose profiles and plasma 1,5-anhydro-D-glucitol in type 2 diabetes poorly controlled by sulfonylurea therapy

Nagoya University Internal Medicine Hotta N Biomedicine and Pharmacotherapy 1996; 50: 297-302

42 Predicting long-term glycemic control of post-educational type Ⅱ diabetic patients by evaluating serum 1,5-anhydroglucitol levels

University of Tsukuba Endocrinology and Metabolism

Sone H Diabetes Research & Clinical Practice 1996; 34: 83-88

43 Clinical significance of measurements of urinary and serum thrombomodulins in patients with non-insulin dependent diabetes mellitus

Dokkyo Medical University Koshigaya Hospital

Pharmaceutical Dept. Inukai T Diabetes Research & Clinical Practice 1996; 33: 99-104

44 Clinical evaluation of insulin resistance improving agent AD-4833 in patients with NIDDM controlled by only diet therapy - a double-blind, randomized, placebo-controlled test-

Yamaguchi Rosai Hospital

Kaneko T The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1491-1514

3 M-7-3A

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Page 4: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 45 Clinical evaluation of insulin resistance improving agent

AD-4833 in NIDDM patients treated with sulfonylurea - a double-blind, randomized, placebo-controlled test-*

Yamaguchi Rosai Hospital

Kaneko T The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1515-1539

46 Clinical evaluation of administration of insulin resistance improving agent AD-4833 in combination with voglibose in NIDDM patients - Phase III open label study -

Yamaguchi Rosai Hospital

Kaneko T The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1540-1556

47 The long-term clinical trial for the evaluation of insulin resistance improving agent AD-4833 in patients with NIDDM - A late phase II study on long-term administration -*

Yamaguchi Rosai Hospital

Kaneko T The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1557-1588

48 The long-term clinical trial for the evaluation of insulin resistance improving agent AD-4833 in patients with NIDDM - A late phase III study on long-term administration -*

Yamaguchi Rosai Hospital

Kaneko T The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1589-1613

49 Pharmacokinetic study of insulin resistance improving agent AD-4833 under long-term administration - Evaluation of drug concentration in blood and efficacy for glucose -*

Hiroshima Kouseiren Hospital

Internal Medicine Takashina S The Japanese Journal of Clinical and Experimental Medicine 1997; 74(6): 1641-1626

50 Rapid improvement of serum 1,5-anhydroglucitol concentrations after administration of α-glucosidase inhibitor

Matsushita Memorial Hospital

Internal Medicine Yoshioka K Diabetes Care 1997; 20(3): 462

51 The effect of the acarbose on 1,5-anhydroglucitol level in patients with diabetes mellitus*

Mito Kyodo Hospital Metabolism and Endocrinology

Boku A Diabetes Frontier 1997; 8: 230-233

52 Study of the clinical usefulness of α-glucosidase inhibitor (voglibose) for the treatment on non-insulin-dependent diabetes

Jikei University General Internal Medicine

Funama K Jpn Pharmacol Ther 1997; 25(8): 2177-2186

53 The effects of α-glucosidase inhibitor, voglibose, on dumping syndrome and diabetes mellitus in patients after gastrectomy

Chita Khosei Hospital Internal Medicine Katagiri K J. New Remedies & Clinics 1997; 46(8): 1098-1104

54 Explanation for discrepancy between fasting plasma glucose and HbA1c*

The Institute for Diabetes Care and Research, Asahi Life Foundation

Kikuchi M Japan Medical Journal 1997; 3840: 105-106

55 Clinical significance of 1,5-anhydroglucitol in patients with diabetes mellitus - The difference among 1,5-AG , HbA1c and fructosamine -*

Gunma University Internal Medicine Shimizu M Current Therapy 1992; 10(10): 191-193

56 The usefulness of plasma 1,5-AG for a marker of glycemic control in diabetic patients

Kawasaki Medical School

Endocrinology Tsushima K Kawasaki Med J 1992; 18(1): 21-24

57 Target level of 1,5-AG in treatment with sulfonylurea* University of Teikyo Internal Medicine Yamanouchi T Japan Medical Journal 1998; 3858: 166

4 M-7-3A

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Page 5: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 58 Effect of gemfibrozil on glucose tolerance in patients with

hyperlipidemia and hyperlipidemia and non-insulin-dependent diabetes mellitus

Saitama Medical School

Internal Medicine Takahashi K J. Clin. Therap. Med. 1997; 13(15): 3949-3976

59 Phase-III Study of a novel hypoglycemic agent AY4166, on NIDDM patients in Japan (2): Placebo-controlled multicenter double-blind study

Siga University of Medical Science

Shigeta Y Clinical Pharmacology and Therapy 1997; 7(5): 729-754

60 Usefulness of combination therapy with sulfonylurea and α-glucosidase inhibitor (voglibose) in non-insulin dependent diabetes mellitus: Effect of reducing the dose of sulfonylurea

Urayasu Hospital of Juntendo University School of Medicine

Internal Medicine Iijima T Jpn Phamacol Ther 1997; 25(3): 841-849

61 Effect of voglibose on glycemic excursions insulin secretion, and insulin sensitivity in non-insulin-treated NIDDM patients

Sasebo Chuou Hospital

Internal Medicine Matsumoto K Diabetes Care 1998; 21(2): 256-260

62 Different effect of acarbose and voglibose on serum 1,5-anhydroglucitol concentrations

Ayabe Municipal Hospital

Internal Medicine Sakane N Diabetes Care 1998; 21(3): 465

63 Response to Sakane et al. Matsushita Memorial Hospital

Internal Medicine Yoshioka K Diabetes Care 1998; 21(3): 465-466

64 α-glucosidase inhibitor: a therapeutic use in diabetes mellitus and the other disorders in glucose metabolism

Fukuoka University Clinical Laboratory Ono J Clinic All-Round 1998; 47(6): 1862-1867

65 Relationship between serum 1,5-anhydroglucitol and urinary excretion of N-acetylglucosaminidase and albumin determined at onset of NIDDM with 3-year follow-up

University of Teikyo Internal Medicine Yamanouchi T Diabetes Care 1998; 21(4): 619-624

66 Acarbose Yamashiro Hospital Internal Medicine Nakano K Japanese Journal of Clinical Medicine 1997; 55(extra): 120-124

67 Combination therapy with sulfonylurea and α-glucosidase inhibitor

Urayasu Hospital of Juntendo University School of Medicine

Internal Medicine Iijima T Japanese Journal of Clinical Medicine 1997; 55(extra): 186-191

68 Case report: A GAD positive patient with diabetes mellitus received diet therapy*

Oomiya Medical Center Jichi Medical University

General Medicine Namai K Diabetes Frontier 1997; 8: 235-243

69 A diabetic case with hemoglobin J-Meerut and low HbA1c levels

Tokai University School of Medicine

Nephrology and Metabolism

Yagame M Internal Medicine 1997; 36(5): 351-356

70 Pioglitazone(AD-4833) ameliorates insulin resistance in patients with NIDDM

Osaka University Internal Medicine Yamazaki M Tohoku J.Exp.Med. 1997; 183: 173-183

71 Insulin-like growth factors-Insulin-like growth factor binding protein axis and diabetic control in insulin-dependent diabetes mellitus

Keio University School of Medicine

Pediatrics Hasegawa T Endocrine J. 1998; 45(Suppl): S129-S131

5 M-7-3A

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Page 6: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 72 Effect of α-glucosidase inhibitor on plasma 1,5-

anhydroglucitol level* Kurihara Clinic Kurihara Y Practice 1998; 15(1): 81-85

73 Case report: A patient with continuous high glucagon level hospitalized for ketoacidosis*

Ebara Hospital Internal Medicine Soeda H Diabetes Frontier 1998; 9(6): 779-786

74 Case report: A difficult case with maintaining good glycemic control for a professional reason

Kanto Chuou Hospital Metabolism Hayashi M Diabetes Frontier 1999; 10(1): 135-141

75 Insulin-sensitizing agent University of Teikyo Internal Medicine Yamanouchi T Japanese Journal of Clinical Medicine 1999; 57(3): 675-680

76 Discrepancy between HbA1c and 1,5-AG* University of Teikyo Internal Medicine Yamanouchi T Doctor Salon 1999; 43(7): 553-557 77 Plasma 1,5-anhydroglucitol compared to glycosylated

hemoglobin as clinical markers for diabetes in first-time patients

Matsuyama Red Cross Hospital

Internal Medicine Yamauchi Y Ehime Medical Journal 1999; 18(4): 540-543

78 Serum 1.5-anhydro-D-glucitol as a new clinical marker for glucose metabolism in type2 diabetes

Shanghai Medical University

Diabetes Research Department

Hongli SHI Chinese Medical Journal 1999; 112(6): 571-573,1999

79 Utility of voglibose long term combined therapy in non-insulin dependent diabetic patients with little effective of sulfonylurea

Ehime Prefectural Central Hospital

Internal Medicine Fujii Y Japanese Journal of Medicine and Pharmaceutical Science 1999; 42(1): 121-129

80 Effect of "Rensen granule" on disorders of glucose metabolism*

Isogo Chuou Hospital Healthcare Tsuchida T Medical Consultation & New Remedies 1999; 36(6): 481-484

81 Effect of restricted physical activity on glycemic control in a type-1 diabetic patients with the mitochondrial DNA 3234 (A to G) mutation

Nagaoka Red Cross Hospital

Medicine and Diabetes Center

Kamoi K J. Japan Diab. Soc. 2000; 43(6): 477-481

82 Comparison of clinical effect between acarbose and voglibose in type 2 diabetes - crossover study - *

Yamashiro Hospital Internal Medicine Nakano K Practice 2000; 17(1): 73-79

83 Glycemic control state of diabetes outpatients* Jyuzen General Hospital

Central Clinical Laboratory

Shiomi A The Ehime Journal of Medical Technology 1997; 16: 57-59

84 Oral glucose tolerance test in sixty gastrectomized subjects with reference to oxyhyperglycemia

Institute of Industrial and Ecological Sciences

Health Policy and Management

Kaji H J. Japan Diab. Soc. 2001; 44(7): 549-554

85 Effect of Nateglinide on uncontrolled type 2 diabetes treated with diet*

Tokyo Medical Center Internal Medicine Koyama K J. New Rem. & Clin. 2001; 50(4): 419-423

86 Dosage selection of sulfonylurea in changing from glibenclimide to Glimepiride*

Teikyo University Internal Medicine Sekine N J. New Rem. & Clin. 2001; 50(7): 717-724

87 Usefulness of data analysis system for diabetic control "Medisafe data vision" *

Juntendo University School of Medicine

Endocrinology and Metabolism

Fujita A Practice 2001; 18(1): 74-80

6 M-7-3A

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Page 7: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 88 Post-load glucose measurements in oral glucose

tolerance tests correlate well with 1,5-anhydroglucitol, an indicator of overall glycaemic state, in subjects with impaired glucose tolerance

Teikyo University Internal Medicine Yamanouchi T Clinical Science 2001; 101: 227-233

89 A double-blind trial on the effects of atorvastatin on glycemic control in Japanese diabetic patients with hypercholesterolemia

Tokyo Medical and Dental University

Internal Medicine Tanaka A Clinica Chimica Acta 2001; 312: 41-47

90 Effect of Chinese herbal medicine (Ginseng Radix Rubra and Kidney-Qi Pill ) - Retrospective study using FPG, HbA1c and 1,5-AG as glycemic marker*

Nishiarai Hospital Internal Medicine Kim M J. New Rem. & Clin. 2001; 50(11),1147-1153

91 Educational hospitalization programs for diabetes patients by Sapporo General Hospital; Effectiveness of short-term physical exercise for type 2 diabetes mellitus

Sapporo City General Hospital

Rehabilitation Shimizu K The Hokkaido Journal of Physical Therapy 2001; 18: 33-39

92 Growth hormone replacement therapy and glucose metabolism*

Fukuoka City Pediatric Hospital

Infection Center Kohno H Annual report of Foundation for Growth Science 2001; 24: 219-221

93 1,5-anhydroglucitol as clinical marker of diabetic control Shizuoka General Hospital

Clinical Laboratory Amemiya N Shizuoka J Med 2001; 16(1), 67-73

94 The effect of high carbohydrate diet on glucose tolerance in patients with type 2 diabetes mellitus

Yamanashi Medical University

Internal Medicine Komiyama N Diabetes Res Clin Pract 2002; 57(3): 163- 170

95 Clinical heterogeneity in elderly patients with diabetes mellitus

Osaka University Aging Fujisawa T Jpn J Geriat 2002; 39(4): 390-392

96 Attempt of at-home medical care using measurement device for urinary glucose, "Well You" and FAX communications system*

Li Internal Medicine Clinic

Li G Practice 2002; 19(1): 89-93

97 Serum 1,5-Anhydroglucitol (GlycoMark TM): A short-term glycemic marker

University of North Carolina School of Medicine

Endocrinology Buse JB Diabetes Technology & Therapeutics 2003; 5(3): 355-363

98 Usefulness of troglitazone administration to obese hyperglycaemic patients with near-normoglycaemia

Teikyo University Internal Medicine Sekino N Diabetes Obes Metab 2003; 5(3): 145-149

99 Changing HbA1c and 1,5-anhydro-D-glucitol in diabetic patients

Osaka Red Cross Hospital

Clinical Laboratory Yamada M Japanese Journal of Medicine and Pharmaceutical Science 2002; 47(3): 475-479

100 Glycated albumin (GA) is highly useful as a glycemic control marker compared with HbA1c under insulin treatment diabetes mellitus (DM) patients

Funayama Clinic Funayama H J. Jap Diab. Soc. 2003; 46(5): 375-379

101 Changing serum urinary acid in type 2 diabetic patients under inpatient management

Tokyo Medical University Hachioji Medical Center

Endocrinology and Metabolism

Ohno A Prog. Med. 2004; 24: 755-759

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Page 8: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 102 Circulating 1,5-Anhydroglucitol levels in adult patients

with diabetes reflect longitudinal changes of glycemia Washington University School of Medicine

McGill JB Diabetes Care 2004; 27(8): 1859-1865

103 Diabetic renal hypouricemia Teikyo University Internal Medicine Yamanouchi T Kidney and Dialysis 2003; 55(2): 353-356

104 Effect of hot spring water drinking on glucose metabolism

Hokkaido University Health Administration Center

Ohtsuka Y Journal of the Japanese Society of Balneology, Climatology and Physical Medicine 2003; 66(4): 227-230

105 Postprandial plasma fructose level is associated with retinopathy in patients with type 2 diabetes

Teikyo University Internal Medicine Kawasaki T Metabolism 2004; 53(5): 583-588

106 Effect of antidiabetic medications on microalbuminuria in patients with type 2 diabetes

Nerima General Hospital

Internal Medicine Yanagawa T Metabolism 2004; 53(3): 353-357

107 Different effects of two α-glucosidase inhibitor, acarbose and voglibose, on serum 1,5-anhydroglucitol (1,5AG) level

Juntendo University School of Medicine

Internal Medicine Watanabe K J Diabetes Complications 2004; 18(3): 183-186

108 Case Report; Delayed increase of serum pancreatic enzymes with onset of a fulminant type 1 diabetes mellitus*

Wakayama Medical University

Internal Medicine Nakao T J. Japan Diab. Soc. 2005; 48(8): 627-631

109 Comparison of metabolic effects of pioglitazone, metformin, and glimepiride over 1 year in Japanese patients with newly diagnosed Type 2 diabetes

Teikyo University Internal Medicine Yamanouchi T Diabetic Medicine 2005; 22(8): 980-985

110 Voglibose Nagoya University Graduate School of Medicine

Internal Medicine Nakamura J Japanese Journal of Clinical Medicine 2005; 63(extra): 457-461

111 The application of plasma 1,5-anhydro-D-glucitol for monitoring type 2 diabetic patients

Poznan Univ. Pharmacology Dworacka M Disease markers 2005; 21(3): 127-132

112 Evaluation of 1,5-AG in diabetic patients treated with α-glucosidase inhibitor*

Kawarazaki Hospital Shirahata M Practice 2005; 22(6): 689-694

113 Comparison of effect on glycemic control between Novorapid 30 mix and Novorin 30R*

Okayama Medical Center

Internal Medicine and Metabolism

Hida K Prog.Med. 2005; 25(8): 2216-2220

114 Factors related to bone metabolism in type 2 diabetes* Itabashi Central General Hospital

Internal Medicine Sasamoto K The Japanese Journal of Clinical and Experimental Medicine 2004; 81(9): 1559-1565

115 Endocrinology and metabolic diseases -especially diabetes mellitus -

Hokkaido University Health Administration Center

Ohtsuka Y Journal of the Japanese Society of Balneology, Climatology and Physical Medicine 2002; 66(1): 21-22,

116 Efficacy and safety of once daily gliclazide (20mg/day) compared with Nateglinide

Juntendo University School of Medicine

Endocrinology and Metabolism

Miwa S Endocrine J 2004; 51(4): 393-398

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 117 Serum uric acid concentrations in type 2 diabetes: its

significant relationship to serum 1,5-anhydroglucitol concentrations

Aichi Medical University

Gotho M Endocrine regulations 2005; 39(4): 119-125

118 Clinical efficacy of miglitol in type 2 Japanese diabetics with diet alone - Phase II dose response study -

Tohoku Kosei Nenkin Hospital

Internal Medicine Goto Y Jpn Pharmacol Ther 2005; 33(11): 1099-1111

119 Disproportionately elevated proinsulin levels in type 2 diabetic patients treated with sulfonylurea

Poznan University of Medical Science

Pharmacology Dworacka M Int J Clin Pharmacol Ther 2006; 44(1): 14-21

120 Effects of Kurozu Moromi Powder and Kurozu concentrated liquid on carbohydrate metabolism

Sakamoto Brewing Co., Ltd.

Nagano M Jpn Pharmacol Ther 2006; 34(2): 199-206

121 Prevalence and correlates of post-prandial hyperglycaemia in a large sample of patients with type 2 diabetes mellitus

Piazzale Stefani University Hospital

Bonora E Diabetologia 2006; 49: 846-854

122 1,5-anhydroglucitol and postprandial hyperglycemia as measured by a continuous glucose monitoring system in patients with inadequately controlled diabetes mellitus

Buse JB Endocrine Practice 2005; 11(Suppl 1): Abstract#912

123 Optimizing glimepiride dose in patients with type 2 diabetes by titration from 3 mg/day to 6 mg/day

Teikyo University Internal Medicine Igarashi K Prog.Med. 2006; 26(9): 2257-2262

124 Short term intensive insulin therapy improves insulin secretion significantly in type 2 diabetic patients

National Hospital Organization Kyushu Medical Center

Metabolism and Endocrinology

Ogo A Fukuoka Acta Med. 2006; 97(9): 277-284

125 The association between glycoxidation and chronic or acute hyperglycaemia in type2 diabetic patients with retinopathy

Poznan University Medical Science

Pharmacology Dworacka M Int J Diabetes & Metabolism 2006; 14(1): 27-31

126 Relationship between 1,5-anhydroglucitol and result of carotid artery ultrasound in elderly patients -cross sectional study in non-diabetic patients - *

Nippon Medical School

geriatrics Ohba K Summary Control Report 2006

127 Pro-Atherogenic alterations in T-Lymphocyte subpopulations related to acute hyperglycaemia in type 2 diabetic patients

Pozan University Medical Science

Pharmacology Dworacka M Circulation Journal 2007; 71: 962-967

128 Evaluation of glucose lowering effects of mitiglinide in type 2 diabetes patients

Yokohama City University

Graduate School of Clinical Research

Tanaka S Jpn Pharmacol Ther2007; 35(supplement): S5-S21

129 Hyperglycemia and diabetic renal change in a model of polyvinyl alcohol bioartificial pancreas transplantation

Kyoto University Organ Reconstruction and Biomaterials

Sakata N Pancreas 2007; 34(4): 458-465

130 Voglibose improves postprandial glycemic state , reduces oxidative stress and prevent progression of arteriosclerosis*

Kyoto Medical Center Sato T Journal of Metabolic Syndrome 2007; 3(1): 62-69

131 Comparison of glimepiride and mitiglinide in drug-naïve type 2 diabetic patients

Jichi Medical University

Endocrinology and Metabolism

Nagasaka S Jpn J Diabet Mast Clin 2007; 5(4): 395-400

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 132 Miglitol increases the adiponectin level and decrease

urinary albumin excretion in patients with type2 diabetes mellitus

Jiyugaoka Medical Clinic

Internal Medicine Yokoyama H Metabolism Clinical and Experimental 2007; 56: 1458-1463

133 Investigation of rapid-acting insulin analogue (insulin aspart) for CSII

Kurume University School of Medicine

Endocrinology Imamura Y J. Japan Diab. Soc. 2008; 51(1): 1-7

134 Does serum 1,5-anhydroglucitol establish a relationship between improvements in HbA1c and postprandial glucose excursions?

Novo Nordisk Inc., Moses AC Diabetic Medicine 2008; 25(2): 200-205

135 Type 1 diabetes mellitus (adult)* Saitama Medical Center

Internal Medicine Maruyama T The Japanese Journal of Clinical Nutrition 2000; 97(4): 499-504

136 Effects of mitiglinide on glucose and lipid metabolism in poorly-controlled type 2 diabetic patients with dyslipidemia

Nippon Medical School

Internal Medicine Watanabe K Therapeutic Research 2008; 29(5): 811-819

137 Current strategies for evaluating, monitoring, and treating type 2 diabetes mellitus

Chino Medical Group Diabetes and headache Intervention Center

Unger J Am J Med. 2008; 121(6,suppl): S3-S8, 2008

138 Relationship between 1,5-anhydroglucitol and development of diabetic retinopathy

Fujisawa Municipal Hospital

Internal Medicine Hoshino K J. Japan Diab. Soc. 2004; 47(11): 845-850

139 1,5-anhydroglucitol and postprandial hyperglycemia as measured by continuous glucose monitoring system in moderately controlled patients with diabetes

University of North Carolina School of Medicine

Endocrinology Dungan KM Diabetes Care 2006; 29(6): 1214-1219

140 Clinical application of 1,5-anhydroglucitol measurements in patients with hepatocyte nuclear factor-1α maturity-onset diabetes of the young

Jagiellonian University

Metabolic Diseases Skupien J Diabetes Care 2008; 31(8): 1496-1501

141 Association of 1,5-anhydroglucitol and 2-h postprandial blood glucose in type 2 diabetic patients

University Hospital Bern

Endocrinology Stettler C Diabetes Care 2008; 31(8): 1534-1535

142 Replacement of voglibose by miglitol resulted in further improvement of glycemic control in patients with type 2 diabetes

Miura Medical Clinic Miura Y Prog.Med. 2008; 28(9): 2241-2244

143 Evaluation of self monitoring of blood ketones by an electrochemical sensor in type 1 diabetes patients

Matsushita Memorial Hospital

Central Clinical Laboratory

Nakajima Y Japanese Journal of Medical Technology 2008; 57(5): 823-827

144 Comparison of pre- vs. postmeal administration of miglitol for 3 months in type 2 diabetic patients

Yokohama City University

Endocrinology and Metabolism

Aoki K Diabetes, Obesity and metabolism 2008; 10(10): 970-972

145 Association of 1,5-anhydroglucitol and 2-h postprandial blood glucose in Type 2 diabetic patients

Isala Clinics Clinical Chemistry Schindhelm RK Diabetes Care 2008; 31(11): e89

146 Association of 1,5-anhydroglucitol and 2-h postprandial blood glucose in Type 2 diabetic patients

University of Bern Endocrinology Stettler C Diabetes Care 2008; 31(11): e90

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 147 Relationship of 1,5-anhydroglucitol (1,5AG) to other

baseline characteristics in insulin-Naïve type 2 diabetes (T2D) patients in the DURABLE trial

Ohio State University Dungan KM ADA 68th Annual Scientific Sessions, June 6-10, 2008

148 Comparison of twice-daily injections of biphasic insulin lispro and basal-bolus therapy: glycaemic control and quality-of-life of insulin-naïve type2 diabetic patients

Kitasato Institute Hospital

Diabetes Center Masuda H Diabetes Obes Metab 2008; 10(12): 1261-1265

149 1,5-Anhydroglucitol reflects postprandial hyperglycemia and a decrease insulinogenic index, even in subjects with prediabetes and well-controlled type 2 diabetes

Sungkyunkwan University School of Medicine

Internal Medicine Won JC Diab. Res. Clin. Pract 2009; 84(1): 51-57

150 Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes

Banyu Pharmaceutical Co.,Ltd.

Nonaka K Diabetes Res Clin Pract 2008; 79(2): 291-298

151 Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion

Tulane University Health Sciences Thethi TK Journal of Diabetes and Its Complications 2010; 24: 73-78

152 Clinical significance of miglitol, new alpha-glucosidase inhibitor, to impaired glucose tolerance

Kurume University School of Medicine

Endocrinology Sato S Therapeutic Research 2009; 30(4): 517-523

153 Racial and ethnic differences in mean plasma glucose, Hemoglobin A1c, and 1,5-Anhydroglucitol in over 2000 patients with type 2 diabetes

University of Michigan

Internal Medicine and Epidemiology

Herman WH J Clin Endocrinol Metab 2009; 94(5): 1689-1694

154 Taspoglutide, a once-weekly human GlP-1 analogue, reduces postprandial glucose (PPG) levels and provides long-term glucose control in ZDF rats

Sebokova E Diabetes 2009; 69th ADA

155 1,5anhydroglucitol concentrations and measures of glucose control and glucose variability in T1DM and T2DM patients

Kuenen JC Diabetes 2009; 69th ADA

156 Utility of 1,5-anhydroglucitol(1,5-AG) in assessing glycemia among youth and adults with type 1 diabetes (T1D)

Mehta SN Diabetes 2009; 69th ADA

157 Unfavorable BNP change with the use of Thiazolidinediones in therapy of mild type 2 diabetes patients

Shirabe S Diabetes 2009; 69th ADA

158 Glycemia indicators influenced on 1,5-anhydroglucitol and hemoglobin A1c among non-diabetic subjects

Nomura K Diabetes 2009; 69th ADA

159 Relationship between long-range correlated glucose fluctuation and indices of glucose control humans

Ogata H Diabetes 2009; 69th ADA

160 Relationship between clinical markers of glycemia and glucose excursion evaluated by continuous glucose monitoring(CGM)

St. Marianna University School of Medicine

Metabolism and Endocrinology

Suwa T Endocr.J. 2010; 57(2): 135-140

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 161 Relationship between long-range correlated glucose

fluctuation and indices of glucose control using continuous glucose monitoring

University of Tokyo Ogata H J.Physiol.Sci 2009; 59(Supplement1): 333

162 Pleiotropic effects of mitiglinide in type 2 diabetes mellitus

Hyogo College of Medicine

Diabetes and Metabolism

Konya H Journal of international medical research 2009; 37(6): 1904-1912

163 The use of 1,5anhydroglucitol level as a clinical test to differentiate subtypes of diabetes

University of Oxford Diabetes Research Laboratories

Owen KR Diabetologia 2009; 52(Suppl1): S105

164 Postprandial glucose levels and long-term glucose control are improved with taspoglutide, a human once-weekly GLP-1 analogue, in an animal model of type 2 diabetes

F.Hoffmann-La Roche AG

Sebokava E Diabetologia 2009; 52(Suppl1): S308

165 BNP elevation following 12-week pioglitazone treatment in patients with type 2 diabetes

Shinkawabashi Hospital

Shirabe S Diabetologia 2009; 52(Suppl1): S335

166 The influence of needle length on glycaemic control and injection-related complaints in obese diabetes subjects

University Medical Center

Endocrinology Kreugel G Diabetologia 2009; 52(Suppl1): S377

167 Urinary myoinositol index: a new and better marker for postprandial hyperglycaemia

Toho University School of Medicine

Diabetes, Metabolism and Endocrinology

Miyagi M Diabetologia 2009; 52(Suppl1): S401

168 Is 1,5AnhydroGlucitol associated with malondialdehyde a marker for oxidase stress?

VU University Medical Center

Diabetes Center Kuenen J Diabetologia 2009; 52(Suppl1): S500-S501

169 Clinical significance of 3 times-daily administration of Humalog Mix 50 (50% insulin lispro and 50% insulin lispro protamine suspension injection) *

Toho University School of Medicine

Diabetes and Endocrinology Center

Kawana H Prog.Med. 2009; 29(11): 2669-2672

170 Evaluation of serum 1,5 anhydroglucitol levels as a clinical test to differentiate subtype of diabetes

University of Oxford Diabetes Research Laboratories

Pal A Diabetes 2010; Care 33(2): 252-257

171 Association between diabetes-related distress and postprandial hyperglycemia in patients with diabetes

University South Caroline School of Medicine

Medicine Coleman SR Canadian Journal of Diabetes 2009; 33(3): 238

172 Serum uric acid levels positively correlated with serum 1,5-anhydroglucitol levels in patients with type 2 diabetes mellitus

Kinki Central Hospital Health Care Center Koga M Official Journal of Japan Society of Ningen Dock 2010; 24(5): 40-44

173 Evaluation of 1,5-anhydroglucitol as a marker for glucose variability in patients with type 2 diabetes mellitus

Kim MJ Diabetes 2010; (70th ADA)

174 1,5-anhydroglucitol, but not fructosamine or HbA1c, predicted glycemic remission in patients of newly diagnosed type 2 diabetes treated with short-term intensive insulin therapy

Liu L Diabetes 2010; (70th ADA)

175 Utility of 1,5-anhydroglucitol (1,5AG) for guiding insulin therapy in type 2 diabetes (T2D) patients (Pts) with suboptimal control on oral antidiabetic agents

Dungan KM Diabetes 2010; (70th ADA)

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 176 Evaluation of relationship between postprandial glucose

level and progression of atherosclerosis in normal glucose-tolerant patients with hypertension of dyslipidemia by using carotid ultrasound variables and serum 1,5-anhydroglucitol (1,5-AG)

Watanabe K Diabetes 2010; (70th ADA)

177 Black-white differences in hemoglobin A1c (HbA1c) and other glycemic markers

Selvin E Diabetes 2010; (70th ADA)

178 1,5-anhydroglucitol level is a useful marker reflects the early response for miglitol therapy in type 2 diabetic patients

Kanda J Diabetes 2010; (70th ADA)

179 A novel new glycemic variability metric Schwartz FL Diabetes 2010; (70th ADA) 180 The investigation of daily profile of blood glucose

analyzed with CGMS in well-controlled with Type 1 diabetes between with and without unaware severe hypoglycemia

Miura J Diabetes 2010; (70th ADA)

181 Clinical use of 1,5-AG (Glycomark) in isle transplantation Gracia MIDO Diabetes 2010; (70th ADA) 182 Dose-ranging efficacy of sitagliptin, a dipeptidyl

peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus

Tokyo Women's Medical University

Diabetes Center Iwamoto Y Endocr J 2010; 57(5): 383-394

183 Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial

Tokyo Women's Medical University

Diabetes Center Iwamoto Y Diabetes Obes Metab 2010; 12, 613-622

184 1,5-anhydroglucitol levels are associated with postprandial hyperglycemia and coronary artery disease in non-diabetic subjects

Yokohama City University Medical Center

Otsuka F Circulation Journal 2010; 74(Suppl.1): 300

185 Lower levels of serum 1,5-anhydroglucitol (1,5-AG) are associated with acute coronary syndrome (ACS)

Disaster Medical Center

Cardiovascular Medicine Kato R Circulation Journal 2010; 74(Suppl.1): 481-482

186 Improvement of postprandial hyperglycemia and arterial stiffness upon switching from premixed human insulin 30/70 to biphasic insulin aspart 30/70

Sakura Hospital Medical Center, Toho University

Center of Diabetes Ohira M Metabolism Clinical and Experimental 2010; 60: 78-85

187 Serum 1,5-anhydroglucitol levels in patients with fulminant type 1 diabetes are lower than those in patients with type 2 diabetes

Kinki Central Hospital Internal Medicine Koga M Clinical Biochemistry 2010; 43: 1265-1267

188 Single administration of α-glucosidase inhibitors on endothelial function and incretin secretion in diabetic patients with coronary artery disease

Juntendo University School of Medicine

Cardiovascular Medicine Hiki M Circulation Journal 2010; 74: 1471-1478

189 Exenatide added to insulin glargine-treated patients with type 2 diabetes provided excellent fasting and postprandial control with weight loss and no increased risk of hypoglycaemia

International Diabetes Center

Bergenstal RM Diabetologia 2010; 53(Suppl1): S37

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 190 Efficacy of miglitol on postprandial glucose control

assessed by continuous glucose monitoring Jichi Medical University

Endocrinology and Metabolism

Nagasaka S Diabetologia 2010; 53(Suppl1): S362

191 The DURABLE Trial: comparing durability of lispro mix 25 vs. glargine

University Medical Center Groningen

Endocrinology Wolffenbuttel BHR

Diabetologia 2010; 53(Suppl1): S383

192 1,5-Anhydroglucitol as a marker of short term glucose variability in well-controlled type 2 diabetes mellitus

Kyung Hee University Hospital

Endocrinology and Metabolism

Lee YJ Diabetologia 2010; 53(Suppl1): S399

193 An information-motivation-behavioral skills analysis in frequent testers

University of Western Ontario

Psychology Kohut T Diabetologia 2010; 53(Suppl1): S419

194 Taspoglutide, a novel human once-weekly analogue of glucagon-like peptide-1, improves glucose homeostasis and body weight in the Zucker diabetic fatty rat

F. Hoffmann-La Roche AG

Sebokova E Diabetes, Obesity and Metabolism 2010; 12: 674-682

195 Correlation between baseline serum 1,5-anhydroglucitol levels and 2-hour post-challenge glucose levels during oral glucose tolerance tests

National Center for Global Health and Medicine

Diabetes and Metabolic Medicine

Goto M Endocr J 2011; 58(1): 13-17

196 The efficacy on 1,5-anhydroglucitol (1,5AG) as a marker of postprandial hyperglycemia by DPP-4 inhibitor sitagliptin

Mejiro Medical Clinic Hisano N Japanese Journal of Medicine and Pharmaceutical Science 2010; 64(4): 589-592

197 Long-term treatment of miglitol ameliorate dyslipidemia and fatty liver in diabetic outpatients

Misaki Naika Clinic Kuribayasi N Therapeutic Research 2010; 31(11): 1617-1623, 2010

198 Case report; A fulminant type 1 diabetes mellitus developed during hospitalization for impaired consciousness*

Tokyo Medical and Dental University

Molecular Endocrinology and Metabolism

Miyake A J. Japan Diab. Soc. 2011; 54(2): 107-111

199 Racial difference in glycemic markers: A cross-sectional analysis of community-based data

Johns Hopkins Bloomberg School of Public Health

Epidemiology and Clinical Research

Selvin E Ann Intern Med 2011; 154(5): 303-309

200 Lower levels of serum 1,5-anhydroglucitol are associated with non-diabetic patients with acute coronary syndrome

災害医療センター Cardiovascular Medicine Ito J JACC 57 2011; (Supplement1): E937

201 Serum 1,5-anhydro-D-glucitol levels predict first-ever cardiovascular disease: An 11-year population-based cohort study in Japan, the Suita study

National Cerebral and Cardiovascular Center

Preventive Cardiology Watanabe M Atherosclerosis 2011; 216: 477-483

202 Nontraditional markers of glycemia - Associations with microvascular conditions

Johns Hopkins Bloomberg School of Public Health

Epidemiology Selvin E Diabetes Care 2011; 34: 960-967

203 Randomized trial on the influence of the length of two insulin pen needle on glycemic control and patient preference in obese patients with diabetes

University Medical Center Groningen

Endocrinology Kreugel G Diabetes Technology & Therapeutics 2011; 13(7): 737-741

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 204 Treatment with the α-glucosidase inhibitor miglitol from

the preonset stage in Otsuka long-evans Tokushima fatty rats improves glycemic control and reduces the expression of inflammatory cytokine gene in peripheral leukocytes

University of Shizuoka

Laboratory of Nutrition Physiology

Mochizuki K Metabolism 2011; 60(11): 1560-1565

205 Relationship between postprandial hyperglycemia and renal tubular function in patients without diabetes

Ouchi M American Diabetes Association 2011; (71st)

206 Is 1,5Anhydroglucitol(Glycomark) a clinically useful test in type 1 diabetes?

Duran-Valdez E American Diabetes Association 2011; (71st)

207 Relationships between glycemia, oxidative stress and inflammation in type 1 diabetic patients using insulin pumps

Jenkins AJ American Diabetes Association 2011; (71st)

208 Clinical Evaluation of DPP-4 inhibitor vildagliptin* Ayame Clinic Ayame H J. New Rem. & Clin. 2011; 60(8): 1569-1575

209 Comparison of efficacy of concomitant administration of mitiglinide with voglibose and double dose of mitiglinide in patients with type 2 diabetes mellitus

Hyogo College of Medicine

Diabetes and Metabolism

Katsuno T J. Diabetes Invest. 2011; 2(3): 204-209

210 Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study

Kansai Electric Power Hospital

Seino Y Current medical research and opinion 2011; 27(9): 1781-1792

211 The beneficial effect of α-glucosidase inhibitor on glucose variability compared with sulfonylurea in Taiwanese type 2 diabetic patients inadequately controlled with metformin: preliminary data

Changhua Chistian Hospital

Endocrinology and Metabolism

Shi-Dou Lin Journal of Diabetes and Its Complications 2011; 25, 332-338

212 Improvement of postprandial hyperglycemia and arterial stiffness upon switching from premixed human insulin 30/70 to biphasic insulin aspart 30/70

Toho University Medical Center Sakura Hospital

Center of Diabetes, Endocrine and Metabolism

Ohira M Journal of Diabetes 2011: 3(SUPPL1): 267

213 Plasma 1,5-anhydroglucitol levels as marker of postprandial hyperglycemia are correlated with severity of left ventricular dysfunction in patients with acute myocardial infarction

University of Fukui Ishida K European heart journal 32(Suppl.1), 1060 ,2011

214 Evaluation of 1,5-anhydroglucitol as a marker for glycemic variability in patients with type 2 diabetes mellitus

Seoul National University College of Medicine

Internal Medicine Kim MJ Acta Diabetol 2013; 50: 505-510

215 Effects of miglitol in combination with intensive insulin therapy on blood glucose control with special reference to incretin responses in type 1 diabetes mellitus

Hyogo College of Medicine

Diabetes and Metabolism

Nagai E Endocr J. 2011; 58(10): 869-877

216 A patients with acute lymphoblastic leukaemia presenting with an extremely high level (21.0%) of HbA1c

Kitasato University School of Medicine

Hematology Suzuki Y Ann Clin Biochem. 2011; 48: 474-477

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 217 Close relationship between serum 1,5-anhydroglucitol

levels and serum uric acid levels in subjects with normal glucose tolerance

Kinki Central Hospital Internal Medicine Koga M Gout and Nucleic Acid Metabolism 2011; 35(1): 9-17

218 Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study

Monteagle Medical Center

Bohannon N Diabetes Technol Ther 2011; 13(10): 1031-1037

219 Does measurement of serum 1,5-anhydroglucitol (1,5-AG) level be able to predict the presence of coronary plaque?

Nagoya Heart Center Murase S J.Am.Coll.Cardiol 2011; 58(20): B169

220 Effect of intensive antidiabetic therapy on sleep-disordered breathing in patients hospitalized for poorly controlled type 2 diabetes mellitus

Osaka University Metabolic Medicine Kashine S The Japan Atherosclerosis Society Annual Meeting 2011; 43rd: 244

221 Retrospective cohort study on cardiovascular event in diabetic patients

National Cerebral and Cardiovascular Center

Preventive Cardiology Miyamoto Y General report in 2010 2011; 84-85

222 Do α-glucosidase inhibition have potential benefits beyond glucose-lowering effect?*

Jichi Medical University

Endocrinology and Metabolism

Nagasaka S Jpn J Diabet Mast Clin 2011; 9(4): 403-407

223 Effect of sitagliptin on postprandial hyperglycemia* KKR Sapporo Medical Center Tonan Hospital

Diabetes and Endocrinology

Hida Y Practice 2011; 28(3): 320-323

224 Effect of periodontal disease treatment on glycemic control in diabetic patients*

Gifu Prefectural General Medical Center

Diabetes and Endocrinology

Yoshino K Prog.Med. 2011; 31(10): 2463-2467

225 Selective contribution of waist circumference reduction on the improvement of sleep-disordered breathing in patients hospitalized with type 2 diabetes mellitus

Osaka University Metabolic Medicine Kashine S Internal Medicine 2011; 50: 1895- 1903

226 Effect of 3-month repeated administration of Miglitol on vascular endothelial function in patients with diabetes mellitus and coronary artery disease

Hyogo Prefectural Awaji Hospital

Cardiovascular Medicine Emoto T The American Journal of Cardiology 2012; 109(1): 42-46

227 Correlation between 1,5-anhydroglucitol and glycemic excursions in type 2 diabetic patients

Chinese People's Liberation Army General Hospital

Endocrinology Sun J Chinese medical Journal 2011; 124(22): 3641-3645

228 Metabolomic biomarkers of impaired glucose tolerance and type 2 diabetes mellitus with a potential for risk stratification in women with polycystic ovary syndrome

Nottingham Medical School

Galazis N Eur J Obstet Gynecol Reprod Biol. 2012; 160(2): 121-130

229 Plasma 1,5anhydroglucitol levels, a measure of short-term glycaemia: Assay assessment and lower levels in diabetic vs. non-diabetic subjects

University of Melbourne

Medicine Januszewski AS Diabetes Res Clin Pract 2012; 95: e17-e19

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 230 A pilot study of the efficacy of miglitol and sitagliptin for

type 2 diabetes with a continuous glucose monitoring system and incretin-related markers

National Center for Global Health and Medicine

Diabetes and Metabolic Medicine

Kishimoto M Cardiovascular Diabetology 2011; 10: 115-123

231 Metabolomic profiling of patients with new-onset type 1 diabetes: an insight into early metabolic changes

Connolly Hospital Endocrinology Tisdall AR Ir. J. Med. Sci. 2011; 180: S501-S502

232 Effect of bile-acid-binding resin (colestimide) on blood glucose and visceral fat in Japanese patients with type 2 diabetes mellitus and hypercholesterolemia; an open-label, randomized, case-control, crossover study

Nippon Medical School

Internal Medicine Suzuki T Journal of Diabetes and its Complications 2011; 26: 34-39

233 Medium-term repeated administration of miglitol improves vascular endothelial dysfunction in diabetic patients with coronary artery diseases - evaluation using Flow-Mediated Dilatation

Hyogo Prefectural Awaji Hospital

Internal Medicine Emoto T Circulation 2011; 124: A9929

234 Characterizing blood glucose variability using new metrics with continuous glucose monitoring data

Ohio University Electrical Engineering and Computer Science

Marling CR Journal of Diabetes Science and Technology 2011; 5(4): 871-878

235 Relationship between serum 1,5-AG levels and macrovascular diseases (coronary artery disease, stroke) in Suita cohort study

Keio University Preventive Medicine and Public Health

Okamura T General report in 2010 2011:171-175

236 Effect of Sitagliptin on the result of 75g OGTT* Minamikosigaya Kenshinkai Clinic

Shuto H J. Saitama M. S. 2011; 46(1): 139-142

237 Effect of DPP-4 inhibitor (sitagliptin) on glucose metabolism and heart and renal function in type 2 diabetic patients*

Hiramitsu Heart Clinic Hiramitsu N Prog.Med. 2012; 32(2): 337-344

238 Does examination of 1,5-anhydroglucitol (1,5-AG) be able to predict a coronary artery plaque?

Nagoya Heart Center Cardiovascular Medicine Cardiovascular Medicine

Murase S Annual Meeting of the Cardiovascular Intervention and Therapeutics 2011; 20th: 445

239 The lack of long-range negative correlations in glucose dynamics is associated with worse glucose control in patients with diabetes mellitus

The University of Tokyo

Educational Physiology Laboratory

Ogata H Metabolism Clinical and Experimental 2012; 61: 1041-1050

240 A study on the association of serum 1,5-anhydroglucitol levels and the hyperglycemia excursions as measured by Continuous Glucose Monitoring System among type 2 diabetes in Chinese population

Zhongda Hospital Endocrinology Wang Y Diabetes Metab Res Rev. 2012; 28: 357-362

241 Serum 1,5-anhydroglucitol is low in gastrectomized men Kinki Central Hospital Internal Medicine Murai J Acta Diabetol 2014; 51(2): 337-338

242 Serum 1,5-anhydroglucitol is associated with diabetic retinopathy in type 2 diabetes

Kangbuk Samsung Hospital

Endocrinology and Metabolism

Kim WJ Diabet Med. 2012; 29(9): 1184-1190

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Page 18: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 243 Potential for use of 1,5-anhydroglucitol when initiating

insulin therapy in people with type 2 diabetes and suboptimal control with oral antidiabetic drugs

Ohio State University Medical Center

Dungan KM Diabetes Res Clin Pract 96, e66-e69, 2012

244 Effects of sex and age on serum 1,5-anhydroglucitol in nondiabetic subjects

Nippon Medical School

Internal Medicine Ouchi M Exp Clin Endocrinol Diabetes 2012; 120: 288-295

245 Clinical significance of insulin glulisine - Comparison with 3 insulin analog -*

Osaka City General Hospital

Metabolism and Endocrinology

Hosoi M J. New Rem. & Clin. 2012; 61(3): 439-445

246 Effect of vildagliptin on daily blood glucose fluctuation in type 2 diabetes*

Taneda Medical Clinic Taneda Y J. New Rem. & Clin. 2012; 61(2): 222-229

247 Clinical effect of DPP-4 inhibitor vildagliptin in type 2 diabetes*

Taneda Medical Clinic Taneda Y J. New Rem. & Clin. 2012; 61(2): 231-237

248 Lower levels of serum 1,5-anhydroglucitol in well controlled diabetic patients with acute coronary syndrome

Tokyo Disaster Medical Center

Cardiovascular Medicine Ito J Circulation Journal 2012; 76(Suppl.1): I-1434

249 Impact of 1,5-anhydro-D-glucitol on restenosis and TLR in patients underwent percutaneous coronary intervention

Tokyo Disaster Medical Center

Cardiovascular Medicine Hirasawa K Circulation Journal 2012; 76(Suppl.1): I-2322

250 Membrane type 1-matrix metalloproteinase is a predictor of coronary plaque in patients with postprandial hyperglycemia

University of Fukui Cardiovasular Medicine Uzui H Circulation Journal 2012; 76(Suppl.1): I-2323

251 The safety, efficacy and predictors for HbA1c reduction of sitagliptin in the treatment of Japanese type 2 diabetes

Kanagawa Physicians Association

The Study Group of the Diabetes Committee

Maeda H Diabetes Res Clin Pract 2012; 95: e20-e22

252 Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes

Kyoto University Diabetes and Clinical Nutrition

Inagaki N Journal of Diabetes Investigation 2011; 2(6): 448-456

253 Alternative markers of glycemia and risk of diabetes in the atherosclerosis risk in communities(ARIC) study

Juraschec SP Diabetes 2012; 61(SUPPL1): A7

254 Vascular health in type 1 diabetes: CSII vs. MDI Januszewski AS Diabetes 2012; 61(SUPPL1): A228 255 The investigation of risk factor for the hypoglycemia

unawareness in patients with type 1 diabetes using CGMS

Miura J Diabetes 2012; 61(SUPPL1): A554

256 The efficacy and safety of the combination usage of mitiglinide and depeptidyl-peptidase-4 inhibitor sitagliptin

Togo M Diabetes 2012; 61(SUPPL1): A622

257 Pilot study of caffeine abstinence for control of chronic glucose in type 2 diabetes

Duke University Medical Center

Psychiatry and Behavioral Sciences

Lane JD Journal of caffeine research 2012; 2(1): 45-47

258 Effect of GLP-1 analogue on continuous glucose monitoring*

Tokyo Jikei University School of Medicine Kashiwa Hospital

Diabetes, Metabolism and Endocrinology

Mori Y The Journal of Therapy 2012; 94(5): 1009-1011

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Page 19: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 259 Serum 1,5-anhydro-D-glucitol levels predict first-ever

cardiovascular disease: An 11-year population-based cohort study in Japan, the Suita study

National Cerebral and Cardiovascular Center

Preventive Cardiology Watanabe M Current Diabetology 2012; 3(3): 164-165

260 Clinical efficacy of miglitol as add-on treatments in type 2 diabetes - Changing of glycemic marker and microalbuminuria*

Komatsu Clinic Komatsu K Diabetes Frontier 2012; 23(3): 351-354

261 Effect of increasing DPP-4 inhibitor vildagliptin on glycemic control*

Iketani Clinic Iketani T J. New Rem. & Clin. 2012; 61(9): 1764-1768

262 Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s)

Kyoto University Diabetes and Clinical Nutrition

Inagaki N Clinical Therapeutics 2012; 34(9): 1892-1908

263 Increased 1,5-Anhydroglucitol predicts glycemic remission in patients with newly diagnosed type 2 diabetes treated with short-term intensive insulin therapy

Sun Yat-Sen University

Endocrinology Liu L Diabetes Technology & Therapeutics 2012; 14(9): 756-761

264 Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): Crossover pilot study (J-VICTORIA study)

Jikei University School of Medicine

Diabetes, Metabolism and Endocrinology

Sakamoto M Cardiovasc Diabetol 2012; 11: 92

265 Miglitol, α-glycosidase inhibitor, reduces visceral fat accumulation and cardiovascular risk factors in subjects with the metabolic syndrome: A randomized comparable study

The University of Tokushima Graduate School of Health Biosciences

Cardio-Diabetes Medicine

Shimabukuro M

Int J Cardiol 2013; 167(5): 2108-2113

266 Improved endothelial cell function and inflammation after replacement of insulin by liraglutide in combination with metformin and sulfonylurea in type 2 diabetic patients

Imamura Bun-in Hospital

Diabetes Kamada T Diabetologia 2012; 55(Suppl1): S321

267 Dipeptidyl peptidase-4 inhibitor (sitagliptin) improves insulin sensitivity and atherosclerosis-related biomarkers in patients with type 2 diabetes

Asahi General Hospital

Diabetes and Metabolic Disease

Yamane T Diabetologia 2012; 55(Suppl1): S323

268 Combination therapy with low dose glimepiride and sitagliptin is effective for poorly controlled Japanese patients with type 2 diabetes

Shinshu University School of Medicine

Aging Medicine Ishii H Diabetologia 2012; 55(Suppl1): S343

269 Alternative markers of hyperglycemia and risk of diabetes Johns Hopkins School of Medicine

Medicine Juraschek SP Diabetes Care 2012; 35(11): 2265-2270

270 Association of alternative markers of glycemia with hemoglobin A1c and fasting glucose

Johns Hopkins School of Medicine

Epidemiology and Clinical Research

Juraschek SP Clinical Chemistry 2012; 58(12): 1648-1655

271 Comparing multiple measures of glycemia: How to transition from biomarker to diagnostic test ?

University of Cincinnati College of Medicine

Medicine Cohen RM Clinical Chemistry 2012; 58(12): 1615-1617

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Page 20: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 272 Relationship between nontraditional and standard

markers of glycemia Johns Hopkins Univ Juraschek SP Circulation 125, AMP039, 2012

273 Serum 1,5-anhydro-D-glucitol(1,5AG) is associated with endothelial dysfunction and coronary plaque vulnerability in diabetes patients with coronary artery diseases

Hyogo Prefectural Awaji Hospital

Cardiovascular Medicine Cardiovascular Medicine

Emoto T Cardiovascular Intervention and Therapeutics 2012; 4(Supplement2): 629

274 Efficacy and safety of switching from insulin glargine to insulin detemir in Japanese type 1 diabetes

Saitama Medical School

Endocrinology and Diabetes

Kurihara S Therapeutic 2012; Research 33(9): 1389-1396

275 Urinary myoinositol index: A new and better marker for postmeal hyperglycemia

Toho University School of Medicine

Diabetes, Metabolism and Endocrinology

Miyagi M Showa Univ J Med 2012; 24(1): 33-41

276 Effect of DPP-4 inhibitor on insulin withdrawal in diabetic patients*

Tama General Medical Center

Internal Medicine Sakurada M Clinical Study Report (2011) 2013:360-363

277 Dose-ranging study of anagliptin in Japanese patients with type 2 diabetes - A multi-center, randomized, placebo-controlled, double-blind, parallel-group study -

Kawasaki Medical School

Diabetes, Endocrinology and Metabolism

Kaku K Jpn Pharmacol Ther 2012; 40(11): 973-984

278 Effectiveness of the glucagon test in estimating islet function for liraglutide treatment in a lean diabetes patient with impaired insulin response to glucose

Gifu University Diabetes and Endocrinology

Iizuka K Diabetol Int 2012; 3: 103-108

279 Clinical efficacy and safety of insulin glulisine in poorly controlled patients with diabetes*

Hiroshima Kyoritsu Hospital

Diabetes Morishita N J. New Rem & Clin 2013; 62(2): 193-199

280 A case of hypoglycemia induced by exenatide, under continuous glucose monitoring in a patients with type 2 diabetes

Kashiwado Hospital Internal Medicine Tokuyama Y J. Japan Diab. Soc. 2013; 56(2): 81-86

281 A multicenter, PhaseIII Evaluation of the efficacy and safety of a new fixed-dose pioglitazone/glimepiride combination tablet in Japanese patients with type 2 diabetes

Takeda Pharmaceutical Co.,Ltd.

Pharmacovigilance Hiroi S Diabetes Technology & Therapeutics 2013; 15(2): 158-165

282 An anti-inflammatory sterol decreases obesity-related inflammation-induced insulin resistance and metabolic dysregulation

Harbor Therapeutics, Inc.

Reading CL Mediators of Inflammation 2013; Article ID 814989: 16

283 Relationship between postprandial glucose level and carotid artery stiffness in patients without diabetes or cardiovascular disease

Nippon Medical School

Internal Medicine Watanabe K BMC Cardiovascular Disorders 2013; 13: 11

284 Comparison of the anti-atherogenic and anti-metabolic effects between miglitol and nateglinide in diabetic patients with coronary artery disease

Hyogo Prefectural Awaji Hospital

Sawada T American Journal of Cardiology 2013; 111(7): 32B

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Page 21: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 285 Effect of 3 times daily insulin aspart 70 in poorly

controlled type 2 diabetes treated with twice daily insulin mix*

Hirosaki University Endocrinology and Metabolism

Matsuhashi Y Prog. Med. 2013; 33(3): 585-588

286 Clinical study of a fixed-dosed mitiglinide/voglibose combination in patients with type 2 diabetes mellitus - Clinical assessment of glycemic markers, HbA1c, glycated albumin and 1,5-anhydroglucitol -

MVCCT Study Group of the Shibuya Medical Association

Hiyoshi T Therapeutic Research 2013; 34(3): 379-390

287 Comparison between sitagliptin and nateglinide on postprandial lipid levels: The STANDARD study

Japanese Red Cross Medical Center

Kojima Y World J Diabetes 2013; 4(1): 8-13

288 Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks

The University of Tokyo

Graduated School of Medicine

Kadowaki T Journal of Diabetes Investigation 2013; 4(2): 174-181

289 Evaluation of glycemic variability in well-controlled type 2 diabetes mellitus

Kyung Hee University School of Medicine

Endocrinology and Metabolism

Chon S Diabetes Technology & Therapeutics 2013; 15(6): 455-460

290 Increased glycemic variability at the onset and during progression of type 2 diabetes - Commentary

Biomedical Informatics Consultants LLC

Rodbard D Diabetes Technology & Therapeutics 2013; 15(6): 445-447

291 The use of 1.5-anhydroglucitol for monitoring glycemic control in islet transplant recipients

Diabetes Research Institute

Peixoto EML Cell Transplant 2014; 23(10): 1213-1219

292 Comparison of the effect of ultra-rapid insulin in intensive insulin therapy*

Kanazawa Red Cross Hospital

Diabetes and Kidney Center

Hamaguchi E J. New Rem. & Clin. 2013; 62(7): 1273-1281

293 Epidemiology of Diabetes and cardiovascular disease* National Cerebral and Cardiovascular Center

Preventive Cardiology Watanabe M Prevention of Arteriosclerosis 2013; 12(1): 12-17

294 Plasma 1,5-anhydroglucitol levels on admission can predict the ventricular function at 1-month after an acute myocardial infarction: A novel predictor

University of Fukui School of Medical Sciences

Cardiovascular Medicine Koike M Circulation Journal 2013; 77(Suppl.I): I-2024

295 Preprocedual lower levels of serum 1,5-anhydroglucitol are associated with restenosis after percutaneous coronary intervention

Tokyo Disaster Medical Center

Cardiology Cardiovascular Medicine

Ito J Circulation Journal 2013; 77(Suppl.I): I-2616

296 1,5-anhydroglucitol is a stronger predictor of coronary artery disease than hemoglobin A1c

National Center for Global Health and Medicine

Cardiovascular Ikeda N Circulation Journal 2013; 77(Suppl.I): I-2617

297 Efficacy and safety of sitagliptin as add-on therapy on glycemic control and blood glucose fluctuation in Japanese type 2 diabetes subjects ongoing with multiple daily insulin injections therapy

Kumamoto University Metabolic Medicine Shimoda S Endocr J. 2013; 60(10): 1207-1214

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 298 Efficacy of alogliptin, a dipeptidyl peptidase-4 inhibitor,

on glucose parameters, the activity of the advanced glycation end product-receptor for advanced glycation end product axis, and albuminuria in Japanese type 2 diabetes

University of Miyazaki

Internal Medicine Sakata K Diabetes Metab Res Rev 2013; 29: 624-630

299 Dipeptidyl peptidase-4 inhibitors improve glycaemic control in latent autoimmune diabetes in adults (LADA) patients insufficiently controlled despite insulin therapy

Gunma University、Schoold of Medicine

Clinical Laboratory Araki O 49th EASD 2013; No.884

300 Two prandial insulin approaches for achieving adequate glycaemic control in patients not at goal HbA1c on basal insulin plus oral agents alone: the AUTONOMY study

University of California San Diego

Veterans Affairs Medical Center

Edelman S 49th EASD 2013; No.1024

301 Switching from intensive insulin therapy to basal supported oral therapy with sitagliptin or glimepiride*

Toyota Kouseiren Hospital

Internal Medicine Katoh D J. New Rem. & Clin. 2013; 62(9): 1561-1568

302 Efficacy and safety of glycemic control in type 2 diabetes patients when switched to mitiglinide/voglibose fixed-dose combination therapy*

Keio University School of Medicine

Nephrology, Endocrinology and Metabolism

Saisyo Y J. New Rem. & Clin. 2013; 62(9): 1569-1575

303 Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose in drug-naïve Japanese patients with type 2 diabetes

St. Marianna University School of Medicine

Metabolism and Endocrinology

Ohta A Expert Opin. Pharmacother 2013; 14(17): 2315-2322

304 Comparison of effects of α-glucosidase inhibitors and glinide drugs on endothelial dysfunction in diabetic patients with coronary artery disease

Himeji Brain and Heart Center

Cardiovascular Medicine Sawada T Circ J. 2014; 78(1): 248-255

305 Effect of Canagliflozin, a sodium glucose co-transporter 2 inhibitor, on measurement of serum 1,5-anhydroglucitol

Janssen Research & Development

Balis DA J Diabetes. 2014; 6(4): 378-380

306 Effect of mulberry leaf extract with enriched 1-deoxynojirimycin content on postprandial glycemic control in subjects with impaired glucose metabolism

Nippon Medical School

Endocrinology and Metabolism

Asai A Journal of diabetes investigation 2011; 2(4): 318-323

307 Ameliorating effects of miglitol on postprandial hyperglycemia and triglyceride/HDL ratio are associated with beneficial impact on atherosclerosis in diabetic patients with coronary artery disease

Hyogo Prefectural Awaji Medical Care Center

Terashita D European heart journal 2013; 34: 414-415

308 Relationship between preprocedual serum 1,5-anhydroglucitol concentrations and restenosis after implantation of drug-eluting stent

Disaster Medical Center

Cardiology Cardiovascular Medicine

Ito J European heart journal 2013; 34: 786

309 Efficacy and safety of switching from intensive insulin therapy to insulin glulisine*

Toyota Kouseiren Hospital

Endocrinology and Metabolism

Katoh D J. New Rem. & Clin 2014; 63(1): 71-77

310 Clinical efficacy of sitagliptin in Japanese type 2 diabetes* Watanabe Clinic Watanabe G J. New Rem. & Clin 2014; 63(2): 192-199

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 311 1,5-anhydroglucitol in saliva is a noninvasive marker of

short-term glycemic control Weill Cornell Medical College

Physiology and Biophysics

Mook-Kanamori DO

J Clin Endocrinol 2014; Metab 99(3): E479-E483

312 Long-term effects of mitiglinide in Japanese diabetics inadequately controlled with DPP-4 inhibitor or biguanide monotherapy

Kawasaki Medical School

Diabetes, Endocrinology and Metabolism

Kaku K Diabetes Ther 2014; 5(1): 97-111

313 Thresholds of various glycemic measures for diagnosing diabetes based on prevalence of retinopathy in community-dwelling Japanese subjects: the Hisayama Study

Kyushu University Environmental Medicine Mukai N Cardiovascular Diabetology 2014; 13:45

314 Circulating CD3+56+ cell subset in pre-diabetes Poznan University Medical Science

Pharmacology Dworacka M Exp Clin Endocrinol Diabetes 2014; 122(2): 65-70

315 Efficacy of adding once- and thrice-daily voglibose in Japanese type 2 diabetic patients treated with alogliptin

Osaka University Graduate School of Medicine

Metabolic Medicine Takahara M Endocr J. 2014; 61(5): 447-456

316 The prognostic value of 1,5-anhydroglucitol Johns Hopkins University

Selvin E Circulation 2014; 129: SUPPL.1

317 Lower 1,5-anhydroglucitol is associated with denovo coronary artery disease in patients at high cardiovascular risk

Saitama Medical Center, Jichi Medical University

Cardiovascular Medicine Fujiwara T Heart and Vessels 2015; 30(4): 469-476

318 Efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes switched from glinides

Mie Chuo Medical Center

Internal Medicine Tanaka T J Diabetes Invest 2014; 5(2): 199-205

319 Successful treatment with liraglutide in a diabetic patients with widely fluctuating blood glucose levels due to the formation of insulin antibodies

Akita Red Cross Hospital

Metabolism Kudo H J. Japan Diab. Soc. 2014; 57(3): 175-180

320 Decreased plasma 1,5-anhydroglucitol in diabetic patients

Akanuma Y Diabetes 1981; 30(Suppl 1): 124A

321 1.5-anhydro-D-glucitol: a novel marker of glucose excursions

Karol Marcinkowski University of Medical Sciences

Pharmacology Dworacka M International Journal of Clinical Practice 2002; Supplement 129: 40-44

322 A patients with variant hemoglobin diagnosed based on abnormal pattern between the s-A1c and A0 peaks on routine laboratory HbA1c measurement using HPLC

Aichi-Gakuin University

Internal Medicine Naruse K J. Japan Diab. Soc. 57(2): 118-123

323 Effectiveness of miglitol combined with various types of insulin therapy for reducing the daily glycemic fluctuation on Japanese type 2 diabetic patients

Toho University School of Medicine

Diabetes, Metabolism and Endocrinology

Hirose T Ther Res 2013; 34(12): 1503-1511

324 What is the determinant for circulating endothelial progenitor cells in patients with coronary artery disease and type 2 diabetes mellitus?

University of Fukui Cardiovascular Medicine Cardiovascular Medicine

Morishita T Circulation Journal 2014; 78(Suppl.1): I-2683

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 325 The relationship between postprandial blood glucose and

coronary plaque stability in stable angina patients; Optical coherence tomography analysis

Urasoe General Hospital

Cardiovascular Medicine Uehara H Circulation Journal 2014; 78(Suppl.1): I-1775

326 Predictive values of 1,5-anhydro-d-glucitol and hemoglobin A1c for prevalence of coronary artery disease in non-diabetic population

National Center for Global Health and Medicine

Cardiovascular Medicine Ikeda N Circulation Journal 2014; 78(Suppl.1): I-1360

327 Clinical efficacy and safety of insulin glulisine* Hiroshima Kyoritsu Hospital

Diabetes Morishita N J. New Rem. & Clin. 2014; 63(3): 345-350

328 Effect of combination therapy with sitagliptin in type 2 diabetes with insulin therapy*

Tama General Medical Center

Internal Medicine Satoh F Clinical Study Report (hospital management in Tokyo, 2012) 2014: 545-549

329 Relationship between average and variability of glucose and glycemic markers in measurement of CGM*

Jichi Medical University

Endocrinology and Metabolism

Nagasaka S Research Report of Daiwa Securities Health Foundation 2014; 37: 18-23

330 1,5-AG as an index of glycemic variability and its application to therapy evaluation

Kashiwado Hospital Internal Medicine Tokuyama Y J. Japan Diab. Soc. 2014; 57(4): 227-234

331 1,5-anhydro-D-glucitol predicts coronary artery disease prevalence and complexity

National Center for Global Health and Medicine

Cardiovascular Medicine Ikeda N Journal of Cardiology 2014; 64(4): 297-301

332 Association of reduced levels of serum 1,5-anhydro-D-glucitol with carotid atherosclerosis in patients with type 2 diabetes

Itoigawa General Hospital

Sato T Journal of Diabetes and Its Complications 2014; 28(3): 348-352

333 Exploratory trial of intranasal administration of Glucagon-Like Peptide-1 in Japanese patients with type 2 diabetes

University of Miyazaki

Neurology,Respirology, Endocrinology and Metabolism

Ueno H Diabetes Care 2014; 37(7): 2024-2027

334 Cotreatment with the α-glucosidase inhibitor miglitol and DPP-4 inhibitor sitagliptin improves glycemic control and reduces the expressions of CVD risk factors in type 2 diabetic Japanese patients

The University of Shizuoka

Laboratory of Nutritional Physiology

Imai C Metabolism 2014; 63(6): 746-753

335 Statins in low doses reduce VEGF and bFGF serum levels in patients with type 2 diabetes mellitus

Poznan University of Medical Science

Pharmacology Dworacka M Pharmacology 2014; 93: 32-38

336 1,5-anhydro-D-glucitol predicts prevalence of coronary artery disease even in non-diabetic adults

National Center for Global Health and Medicine

Cardiovascular Medicine Ikeda N Journal of the American College of Cardiology 2014; 63(Issue 12): A1331

337 Low levels of 1,5-anhydro-D-glucitol are associated with vascular endothelial dysfunction in type 2 diabetes

University of Occupation and Environmental Health

Internal Medicine Torimoto K Cardiovascular Diabetology 2014; 13: 99

338 Effect of repaglinide, administered two of three times daily for 3 months, on glycaemic control in Japanese patients with type 2 diabetes mellitus

Yokohama City University Graduate School of Medicine

Endocrinology and Metabolism

Kamiyama H Journal of International Medical Research 2014; 42(5): 1150-1160

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 339 Effects of intake of puffed wx ae double mutant brown

rice on human blood glucose and lipid levels Osaka Prefecture University

Rehabilitation Horino S J Life Sci Res 2011; 9: 7-11

340 The effects of combination therapy with miglitol and sitagliptin in patients with type 2 diabetes who showed an inadequate response to monotherapy with either agent

Nakakinen Clinic Osonoi K Medical Consultation & New Remedies 2011; 48(5): 471-482

341 Addition of sitagliptin improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes on glinides monotherapy

Tajima N Diabetes 2014; 63: A268 (74th ADA)

342 The relationship among alternative markers of glycemia and A1C, 2-hr PG, and continuous glucose monitoring in obese adolescents

Chan LC Diabetes 2014; 63: A314-A315 (74th ADA)

343 A prospective metabonomics analysis reveals new pathways involved in T2D development

Arredouani A Diabetes 2014; 63: A414 (74th ADA)

344 1,5-anhydroglucitol and methylglyoxal - new post-mortem marker for glucose metabolism disorders?

Institute of Forensic Medicine

Hess C Rechtsmedizin 2011; 21(4): 406-407

345 The soluble isoform of the receptor for advanced glycation end products (esRAGE) as a biomarker for long-term glycemic control in type 2 diabetes

Federal University of Parana

Anghebem-Oliveria MI

Clin Chem Lab Med 2014; 52(Special Suppl.): S639

346 Effects of standard dose of vildagliptin vs sitagliptin on blood glucose fluctuations evaluated by long-term self-monitoring blood glucose (SMBG)

Hokkaido University Medine II Kimachi K Diabetologia 2014; 57(Suppl 1): S379

347 Plasma amino acid profiles are associated with insulin, C-peptide and adiponectin levels in type 2 diabetic patients

Ajinomoto Co., Inc. Institute for innovation Nakamura H Nutr Diabetes 2014; 4: e133 (1-8)

348 Association of 1,5-anhydroglucitol with diabetes and microvascular conditions

Johns Hopkins Bloomberg School of Public Health

Epidemiology Selvin E Clin Chem. 2014; 60(11): 1409-18

349 Moving beyond mean glycemia: 1,5-anhydroglucitol and microvascular complications of diabetes

Harvard Medical School

Cardiovascular Division Lawler PR Clin Chem. 2014; 60(11): 1359-1361

350 Effect of sitagliptin on glycemic control and beta cell function in Japanese patients given basal-supported oral therapy for type 2 diabetes

St. Marianna University School of Medicine

Metabolism and Endocrinology

Asai S Endocr J 2014; 61(12): 1213-1220

351 Effect of sitagliptin on glycemic control in type 2 diabetes treated with low dose of glimepiride*

Iwamizawa Municipal General Hospital

Internal Medicine Yoshimura H Diabetes Frontier 2013; 24(6): 747-751

352 The efficacy of sitagliptin on glycemic control in type 2 diabetes with treatment of vildagliptin

Hotaruno Central Clinic of Internal Medicine

Uchida D Medical Consultation & New Remedies 2014; 51(5): 519-522

353 The efficacy of combination therapy with α-glucosidase inhibitor plus DPP-4 inhibitor*

Hotaruno Central Clinic of Internal Medicine

Uchida D Ther Res 2014; 35(6): 615-620

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 354 Strong correlation between glycaemic variability and

total glucose exposure in type 2 diabetes is limited to subjects with satisfactory glycaemic control

Dong-A University Medical Center

Endocrinology and Metabolism

Suh S Diabetes & Metabolism 2014; 40(4): 272-277

355 Clinical significance of measurement of 1,5-anhydroglucitol in patients with coronary artery disease and acute coronary syndrome

Juntendo University School of Medicine

Cardiovascular Medicine Sai E Circulation Journal 2014; 78(Suppl.I): OE-154

356 Efficacy of alogliptin on glucose parameters, the activity of the advanced glycation end product- receptor for advanced glycation end product axis, and albuminuria in uncontrolled type 2 diabetes

University of Miyazaki

Sakata K The Journal of Clinical Hypertension 2013; 15(suppl.1): A45

357 Prescription and quality of diabetes care provided by specialists and general physicians in Japan - An analysis of insurance claim and health checkup data -

SANYO Electric Group Health Insurance

The Health Care Center Hidaka H J. Japan Diab. Soc. 2014; 57(10): 774-782

358 Comparative associations of diabetes risk factor with five measures of hyperglycemia

The Welch Center for Prevention

Epidemiology Poon AK BMJ Open Diabetes Res Care. 2014; Apr 8;2(1) [Epub ahead of print]

359 Concomitant use of miglitol and mitiglinide as initial combination therapy in type 2 diabetes mellitus

Kawasaki Medical School

Diabetes, Endocrinology and Metabolism

Tatsumi F Diabetes Research & Clinical Practice 2013; 101(1): 35-44

360 Randomized, double-blind, dose-ranging study of TAK-875, a novel GPR40 agonist, in Japanese patients with inadequately controlled type 2 diabetes

Kawasaki Medical School

Diabetes, Endocrinology and Metabolism

Kaku K Diabetes Care 2013; 36(2): 245-250

361 Mitiglinide/voglibose fixed-dose combination improves postprandial glycemic excursions in Japanese patients with type 2 diabetes mellitus

Yuri Ono Clinic Diabetes Ono Y Expert Opin. Pharmacother 2013; 14(4): 361-370

362 Effects of combination therapy with mitiglinide and voglibose on postprandial plasma glucose in patients with type 2 diabetes mellitus

Ashiya Municipal Hospital

Internal Medicine Konya H Diabetes, Metabolic Syndrome and Obesity: Target and Therapy 2013; 6: 317-325

363 Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes

Jikei University School of Medicine

Metabolic Diseases Tajima N Journal of Diabetes Investigation 2013; 4(6): 595-604

364 Efficacy and safety of sitagliptin add-on therapy in Japanese patients with type 2 diabetes on insulin monotherapy

The University of Tokyo

Metabolic Diseases Kadowaki T Diabetol Int 2013; 4: 160-172

365 'Patient-centered care' for complex patients with type 2 diabetes mellitus - Analysis of two cases

University of Massachusetts Boston

Nursing and Health Science

Hackel JM Clinical Medicine Insights: Endocrinology and Diabetes 2013; 6: 47-61

366 Effects of alogliptin in chronic kidney disease patients with type 2 diabetes

Nippon Medical School Musashikosugi Hospital

Nephrology Sakai Y Internal Medicine 2014; 53: 195- 203

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 367 SYR-472, a novel once-weekly dipeptidyl peptidase-4

(DPP-4) inhibitor, in type 2 diabetes mellitus: a phase 2 randomized, double-blind, placebo-controlled trial

Kyoto University Graduated School of Medicine

Diabetes Inagaki N Lancet Diabetes Endocrinol 2014; 2: 125-132

368 Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomized trial

VU University Medical Center

Diabetes Center Diamant M Lancet Diabetes Endocrinol 2014; 2: 464-473

369 The glycemic/metabolic responses to meal tolerance tests at breakfast, lunch and dinner, and effects of the mitiglinide/voglibose fixed-dose combination on postprandial profiles in Japanese patients with type 2 diabetes mellitus

Yuri Ono Clinic Diabetes Ono Y Expert Opin. Pharmacother. 2014; 15(3): 311-324

370 Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase

Kawasaki Medical School

Diabetes, Endocrinology and Metabolism

Kaku K Expert Opin. Pharmacother. 2014; 15(15): 2121-2130

371 Initiation and gradual intensification of premixed insulin lispro therapy versus basal ±mealtime insulin in patients with type 2 diabetes eating light breakfast

Second University of Naples

Geriatrics and Metabolic Diseases

Giugliano D Diabetes Care 2014; 37(2): 372-380

372 AUTONOMY: The first randomized trail comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes

University of California

Medicine Edelman SV Diabetes Care 2014; 37(8): 2132-2140

373 Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes

VU University Medical Center

Diabetes Center Diamant M Diabetes Care 2014; 37(10): 2763-2773

374 Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with α-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on sulfonylurea alone (SUCCESS-2): a multicenter, randomized, open-label, non-inferiority trial

Chiba University Graduate School of Medicine

Clinical Cell Biology and Medicine

Kobayashi K Diabetes, Obesity and Metabolism 2014; 16(8): 761-765

375 The effect of addition of liraglutide to high-dose intensive insulin therapy: a randomized prospective trial

Mountain Diabetes and Endocrine Center

Lane W Diabetes, Obesity and Metabolism 2014; 16: 827-832

376 Using miglitol at 30 min before meal is effective in hyperinsulinemic hypoglycemia after a total gastrectomy

Yokohama-City University

Endocrinology and Metabolism

Shirakawa J Endocrine Journal 2014; 61(11): 1115-1123

377 Profile of saxagliptin in the treatment of type 2 diabetes: focus on Japanese patients

Ashiya Municipal Hospital

Internal Medicine Konya H Therapeutics and Clinical Risk Management 2014; 10: 547-558

378 Differences between rosuvastatin and atorvastatin in lipid-lowering action and effect on glucose metabolism in Japanese hypercholesterolemic patients with concurrent diabetes - Lipid-lowering with highly potent statins in hyperlipidemia with type 2 diabetes patients (LISTEN) study -

Kumamoto University Cardiovascular Medicine Ogawa H Circulation Journal 2014; 78: 2512-2515

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 379 Comparison of the administration of teneligliptin every

day versus every other day in Japanese patients with type 2 diabetes: A randomized non-inferior test

Yokohama-City University

Endocrinology and Metabolism

Kamiko K Journal of Clinical Pharmacology 2015; 55(2): 144-151

380 Vildagliptin vs liraglutide as a second-line therapy switched from sitagliptin-based regimens in patients with type 2 diabetes: A randomized, parallel-group study

Kanazawa University Graduated School of Medical Sciences

Disease Control and Homeostasis

Takeshita Y J Diabetes Invest 2015; 6(2): 192-200

381 Association of retrospective markers of glycemia and the use of continuous glucose monitoring in white adults with type 2 diabetes mellitus - a preliminary report

Jagiellonian University

Diagnostics Solnica B Clin Chem Lab Med 2015; 53(1): e15-e17

382 Salivary protein glycosylation as a noninvasive biomarker for assessment of glycemia

Nizam's Institute of Medical Sciences

Rao PV Journal of Diabetes Science and Technology 2015; 9(1): 97-104

383 Predictive value of 1,5-anhydroglucitol for prevalence of coronary artery disease in non-diabetic adults

National Center for Global Health and Medicine 国立国際医療研究センター

Caridiology Cardiovascular Medicine

Ikeda N European Heart Journal 2014; 35(Suppl1): 399

384 A pilot three-month sitagliptin treatment increases serum adiponectin level in Japanese patients with type 2 diabetes mellitus- a randomized controlled trial START-J study

Osaka University Metabolic Medicine Hibuse T Cardiovascular Diabetology 2014; 13: 96

385 Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: A phase I, single-center, open-label, randomized study

Peking Union Medical College Hospital

Clinical Pharmacology Chen X Clinical Therapeutics 2014; 36(8): 1196-1210

386 The rs10885122 polymorphism of the adrenoceptor alpha 2A (ADRA2A) gene in Euro-Brazilians with type 2 diabetes mellitus

Federal University of Parana

Pharmaceutical Sciences Welter M Arch Endocrinol Metab. 2015; 59: 29-33

387 GlycA is novel marker of inflammation among non-critically ill hospitalized patients with type 2 diabetes

The Ohio State University

Endocrinology, Diabetes and Metabolism

Dungan KM Inflammation 2015; Jan 15 [Epub ahead of print]

388 Glycated albumin is more closely correlated with coronary artery disease than 1,5-anhydroglucitol and glycated hemoglobin A1c

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Endocrinology and Metabolism

Ma X Cardiovascular Diabetology 2015; 14: 16

389 1,5-anhydroglucitol as a useful marker for assessing short-term glycemic excursions in type 1 diabetes

Uijeongbu St. Mary's Hospital

Endocrinology and Metabolism

Seok H Diabetes Metab J. 2015; 39(2): 164-170

390 Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study

Kyoto University Graduated School of Medicine

Diabetes, Endocrinology and Nutrition

Inagaki N Lancet. Diabetes & Endocrinology 2015; 3(3): 191-197

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 391 Racial differences in hyperglycemia: Comparative value of

traditional and nontraditional glycemic markers Johns Hopkins Bloomberg Sch of Public Health

Epidemiology Parrinello CM Circulation 2015; 131: AP296

392 Glycemic excursions and cognitive function in older adults with diabetes

Johns Hopkins University

Rawlings A Circulation 2015; 131: AP339

393 Association of cerebral white matter lesions with cognitive function and mood in Japanese elderly people: a population-based study

Tottori University Neurology Yamawaki M Brain Behav. 2015; 5(3): 8

394 Two non-diabetic cases of variant hemoglobin treated with oral hypoglycemic agents due to spurious HbA1c elevation

Osaka General Medical center

Diabetes and Metabolism

Shimizu S J. Japan Diab. Soc. 2015; 58(2): 121-127

395 Two patients with low HbA1c levels due to subclinical hemolysis

Kawanishi City Hospital

Internal Medicine Nakamura Y J. Japan Diab. Soc. 2015; 58(2): 128-135

396 1,5-anhydroglucitol is associated with early-phase insulin secretion in Chinese patients with newly diagnosed type 2 diabetes mellitus

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Endocrinology and Metabolism

Ma X Diabetes Technol Ther. 2015; 17(5): 320-326

397 Association of serum 1,5-anhydro-D-glucitol with coronary artery atherosclerosis and epicardial adipose tissue volume assessed by computed tomography in non -diabetic patients

Kurekyosai Hospital Cardiology Cardiovascular Medicine

Kunita E 79th Annual Sceintific Meeting of JCS 2015; OJ-021

398 Impact of serum 1,5-anhydro-d-glucitol value on prediction of major adverse cardiac and cerebrovascular events

National Center for Global Health and Medicine

Cardiology Cardiovascular Medicine

Ikeda N 79th Annual Sceintific Meeting of JCS 2015; OJ-050

399 Efficacy of dipeptidyl peptidase-4 inhibitor for cardiac function in diabetic patients with ischemic heart disease

Nihon University School of Medicine

Cardiology Cardiovascular Medicine

Kitano D 79th Annual Sceintific Meeting of JCS 2015; OJ-053

400 Serum levels of 1,5-anhydroglucitol predict in-stent restenosis after drug-eluting stent implantation

Disaster Medical Center

Cardiology Cardiovascular Medicine

Yamamoto T 79th Annual Sceintific Meeting of JCS 2015; PE-357

401 Efficacy of dipeptidyl peptidase-4 inhibitor for cardiac function in diabetic patients with ischemic heart disease

Nihon University School of Medicine

Cardiology Cardiovascular Medicine

Kitano D JACC 2015; 65(10): A1417

402 Lower 1,5-anhydroglucitol is associated with adverse clinical events after percutaneous coronary intervention

Jichi Medical University

Cardiovascular Medicine Fujiwara T Heart Vessels 2016; 31: 855-862

403 Efficacy of switching from premix analog insulin twice daily injection to insulin glargine once daily injection with sitagliptin

Minamiakatsuka Clinic

Internal Medicine Takahashi H Diabetol Int 2015; 6: 33-38

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 404 1,5-anhydro-D-glucitol can reflect hypoglycemia in

patients with well controlled type 2 diabetes Seoul National University Hospital

Internal Medicine Kim MK Diabetes Research and Clinical Practice 2014; 106(SUPPL. 1): S90-S91

405 Low levels of C-peptide have clinical significance for established type 1 diabetes

Faustman DL Diabetes 2015; 64(SUPPL.1): A71-A72

406 Risk prediction of major complications in persons with diabetes

Parrinello CM Diabetes 2015; 64(SUPPL.1): A72

407 Glycemic variability correlates with 1.5-anhydroglucitol (1.5-AHG) but not with markers of oxidation, inflammation, and endothelial function: Baseline characteristics of the CAROLINA CGM substudy

Mazze RS Diabetes 2015; 64 (SUPPL.1): A246

408 Insulin mid mixture lispro mix50 (LM50) showed better glycemic control than low mixture lispro mix 25 (LM25) as starter insulin in Chinese patients with type 2 diabetes mellitus (T2DM): A subgroup analysis of CLASSIFY study

Su Q American Diabetes Association 2015; (75th)

409 The effect of fasting status on 23 cardiometablic biomarkers in 96,000 subjects

Varvel SA American Diabetes Association 2015; (75th)

410 Short-term total variability in nontraditional biomarkers of hyperglycemia in older adults

Parrinello CM Diabetes 2015; 64(SUPPL.1): A433-434

411 Point-of-Care salivary protein glycosylation test for assessment of short-term glycemia

Roberts CT Diabetes 2015; 64(SUPPL.1): A636

412 Capsule commentary on Radin, Pitfalls in hemoglobin A1c measurement: When results may be misleading

San Francisco VA Medical Center

Feingold KR J Gen Intern Med 2013; 29(2): 363

413 Increased circulating RANTES in type 2 diabetes Poznan University of Medical Sciences

Pharmacology Dworacka M Eur. Cytokine Netw. 2014; 25(3): 46-51

414 Add-on treatment with teneligliptin ameliorates glucose fluctuations and improves glycemic control index in Japanese patients with type 2 diabetes on insulin therapy

Dokkyo Medical University

Endocrinology and Metabolism

Tanaka S Diabetes Technology & Therapeutics 2014; 16(12):840-845

415 Switching from ultra-rapid insulin therapy to mitiglinide in patients with Basal bolus treatment*

Akita Red Cross Hospital

Metabolism Goto T Diabetes Frontier 2015; 26(2): 229-232

416 HOMA-IR values are associated with glycemic control in Japanese subjects without diabetes or obesity: the KOBE study

Foundation for Biomedical Research and Innovation

Hirata T J Epidemiol 2015; 25(6): 407-414

417 Association of hemoglobin A1c and glycated albumin with carotid atherosclerosis in community-dwelling Japanese subjects: the Hisayama Study

Kyushu University Center for Cohort Studies

Mukai N Cardiovascular Diabetology 2015; 14: 84

418 Low levels of C-peptide have clinical significance for established Type 1 diabetes

Harvard Medical School

Immunobiology Laboratory

Kuhtreiber WM

Diabet Med. 2015; 32(10): 1346-1353

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 419 Discrimination of sulfonylureas -How to use gliclazide and

glimepiride properly ? - National Hospital Organization Kagoshima Medical Center

Diabetes and Endocrine Medicine

Ijuin T Prog. Med. 2015; 35(7): 1217-1224

420 Effects of liraglutide monotherapy on beta cell function and pancreatic enzymes compared with metformin in Japanese overweight/obese patients with type 2 diabetes mellitus: A subpopulation analysis of the KIND-LM randomized trial

Keio University School of Medicine

Internal Medicine Tanaka K Clin Drug Investig 2015; 35(10): 675-684

421 Sitagliptin versus mitiglinide switched from mealtime dosing of a rapid-acting insulin analog in patients with type 2 diabetes: a randomized, parallel-group study

Kanazawa University Graduated School of Medical Sciences

Disease Control and Homeostasis

Takeshita Y BMJ Open Diabetes Res Care. 2015; 3: e000122

422 Teneligliptin improves left ventricular diastolic function and endothelial function in patients with diabetes

Kitasato University School of Medicine

Cardiovascular Medicine Hashikata T Heart Vessels 2016; 31: 1303-1310

423 Effect of postprandial hyperglycemia on coronary flow reserve in patients with impaired glucose tolerance and type 2 diabetes mellitus

University of Fukui Cardiovascular Medicine Ikeda H Diabetes & Vascular Disease Research 2015; 12(6): 405-410

424 Association of 1,5-anhydroglucitol with cardiovascular disease and mortality

Johns Hopkins Bloomberg School of Public Health

Epidemiology and the Welch Center for Prevention

Selvin E Diabetes 2016; 65(1): 201-208

425 Case study: type 2 diabetes treated with DPP-4 inhibitor in combination with mitiglinide/voglibose combination tablets*

Kyorin University Hospital

Internal Medicine Sumitani Y Calm 2015; 2(2): 14-15

426 Is it possible to switch from intensive insulin therapy to therapy with glargine and sitagliptin or glimepiride in type 2 diabetes? *

Toyota Kousei Hospital

Internal Medicine Kato D Journal of New Remedies and Clinic 2015; 64(6): 635-643

427 Impact of serum 1,5-anhydro-d-glucitol value on prediction of major adverse cardiac and cerebrovascular events

National Center for Global Health and Medicine

CardiologyCardiovascular Medicine

Ikeda N European Heart Journal 2015; 36(SUPPL.1): 18

428 Impact of low serum levels 1,5-anhydroglucitol on cardiovascular events in patients after first-time elective percutaneous coronary intervention

Juntendo University School of Medicine

Cardiology Cardiovascular Medicine

Takahashi S European Heart Journal 2015; 36(SUPPL.1): 641

429 Total short-term variability in biomarkers of hyperglycemia in older adults

Johns Hopkins Bloomberg School of Public Health

Epidemiology and Welch Center for Prevention

Parrinello CM Clinical Chemistry 2015; 61(12): 1540-1541

430 Model analysis of effect of canagliflozin (Invokana), a sodium-glucose cotransporter 2 inhibitor, to alter plasma 1,5-anhydroglucitol

Jefferson University Hospitals

Pathology Fortuna D Clinical Chimica Acta 2016; 452: 138-141

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 431 Ability of 1,5-anhydro-D-glucitol values to predict

coronary artery disease in a non-diabetic population National Center for Global Health and Medicine

Cardiovascular Medicine Ikeda N Int Heart J 2015; 56(6): 587-591

432 Racial differences in glycaemic marker levels among individuals without diabetes: the coronary artery risk development in young adults study

University of Alabama

Cardiology Carson AP Diabetologia 2015; 58(Suppl 1): S178

433 Glycaemic variability correlates with 1.5-AHG but not with markers of oxidation, inflammation and endothelial function: baseline results of the CAROLINAⓇ CGM substudy

International Diabetes Center

Mazze R Diabetologia 2015; 58(Suppl 1): S564

434 Plasma metabolomic profiles in association with type 2 diabetes risk and prevalence in Chinese adults

Vanderbilt Epidemiology Center

Epidemiology Yu D Metabolomics 2016; 12: 3

435 Racial differences in and prognostic value of biomarkers of hyperglycemia

Johns Hopkins University

Epidemiology and the Welch Center for Prevention

Parrinello CM Diabetes Care 2016; 39(4): 589-595

436 Effect of daily glucose fluctuation on coronary plaque vulnerability in patients pre-treated with lipid-lowering therapy

Kobe University Graduate School of Medicine

Cardiovascular Medicine Kuroda M JACC. Cardiovascular Intervention 2015; 8(6): 800-811

437 Low and exacerbated levels of 1,5-anhydroglucitol are associated with cardiovascular events in patients after first-time elective percutaneous coronary intervention

Juntendo University School of Medicine

Cardiology Cardiovascular Medicine

Takahashi S Circulation 2015; 132: A18444

438 1,5-anhydro-d-glucitol as a predictor of cerebral infarction in patients with glycated hemoglobin A1c based good diabetes control

Brain Attack Center Ota Memorial Hospital

Siga Y Stroke 2016; 47: ATP208

439 Metabolomic biomarkers for personalised glucose lowering drugs treatment in type 2 diabetes

University Medical Centre Utrecht

Julius Centre for Health Sciences and Primary Care

Ouden Hd Metabolomics 2016; 12:27

440 Glucose peaks and risk of dementia among persons with diabetes: The atherosclerosis risk in communities (ARIC) study

Johns Hopkins University

Rawlings A Circulation 2016; 133(Suppl 1): MP77

441 Association of 1,5-anhydroglucitol with subclinical cardiovascular disease

Johns Hopkins University

Liang M Circulation 2016; 133(Suppl 1): P047

442 The association of serum glycated albumin with the prevalence of diabetic retinopathy in Korean patients with type 2 diabetes mellitus

Kangbuk Samsung Hospital

Endocrinology and Metabolism

Jeon WS Diabetes Res Clin Pract 2016; 116: 46-53

443 Efficacy of metreleptin in patients with type 1 diabetes Vasandani C ADA 2016; 76th 444 Total fat mass and BMI exhibit varying associations with

glycemic markers Carson AP ADA 2016; 76th

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 445 Translational genetic approaches for diagnosing

monogenic diabetes in Singapore Gardner D ADA 2016; 76th

446 Comparison of diurnal glycemic variability on day 1 vs. day 7 of treatment with the once-weekly DPP-4 inhibitor trelagliptin

Onishi T ADA 2016; 76th

447 Efficacy and safety of mitiglinide/voglibose fixed-dose combination tablet compared with dipeptidyl peptidase-4 inhibitors: Results of a cross-over study

Keio University Endocrinology, Metabolism and Nephrology

Tanaka M Therapeutic Research 2016; 37(3): 285-291

448 Personalised glycaemic control in critically ill type-2 diabetic patients: An exploratory study

Royal Adelaide Hospital

Intensive Care Unit Kar P Anaesth Intensive Care 2016; 44(2): 307-308

449 Association of CD34/CD133/VEGFR2-positive cell numbers with eicosapentaenoic acid and postprandial hyperglycemia in patients with coronary artery disease

University of Fukui Cardiovascular Medicine Morishita T International Journal of Cardiology 2016; 221: 1039-1042

450 Association of 1,5-anhydroglucitol, a biomarker of glucose peaks, with subclinical cardiovascular disease

Johns Hopkins University

Epidemiology and the Welch Center for Prevention

Liang M Diabetes Care 2016; 39(10): 1752-1759

451 Impact of serum 1,5-anhydro-d-glucitol value on prediction of major adverse cardiac and cerebrovascular events in non-diabetic patients without coronary artery disease

National Center for Global Health and Medicine

Cardiovascular Medicine Ikeda N Atherosclerosis 2016; 253: 1-6

452 Do glycemic marker levels vary by race? Differiing results from a cross-sectional analysis of individuals with and without diagnosed diabetes

University of Alabama

Epideomiology Carson AP BMJ Open Diabetes Research and Care 2016; 4: 1-8

453 Impact of diet on efficacy of insulin lispro 25/75 and insulin lispro 50/50 as starter insulin in East Asian patients with type 2 diabetes: subgroup analysis of the CLASSIFY randomized trial

Peking Union Medical College Hospital

Parenteral and Enteral Nutrition

Chen W J Diabetes Investig 2016 June 11 [Epub ahead of print]

454 1,5-anhydro-D-glucitol could reflect hyperglycemia risk in patients with type 2 diabetes receiving insulin therapy

Seoul National University College of Medicine

Internal Medicine Kim MK Endocrinol Metab 2016; 31: 284-291

455 Serum bilirubin levels are positively associated with glycemic variability in women with type 2 diabetes

Seoul National University College of Medicine

Internal Medicine Kim LK J Diabetes Investig 2016; 7(6): 874-880

456 Factors influencing inter-day glycemic variability in diabetic outpatients on insulin therapy

University of Occupational and Environmental Health

Internal Medicine Mori H J Diabetes Investig 2016 July [Epub ahead of print]

457 Clincial effect of real time pulse rate monitoring with a portable pulsimeter on physical exercise therapy for male patients with type 2 diabetes

Kyorin University School of Medicine

Diabetes, Endocrinology and Metabolism

Sumitani Y Diabetol Int 2016; 7: 228-234

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 458 Liberal glycemic control in critically ill patients with type 2

diabetes: An exploratory study University of Adelaide Acute Care Medicine Kar P Critical Care Medicine 2016;

44(9): 1695-1703 459 Achievement rate of glycemic control for therapy with

sitagliptin in type 2 diabetes* Jikei University School of Medicine

Diabetes, Metabolism and Endocrinology

Utsunomiya K Prog. Med. 2015; 35(3): 563-569

460 Effects of switching from dipeptidyl peptidase-4 inhibitors taken once daily to vildagliptin taken twice daily on glycemic control in Japanese patients with type 2 diabetes

Komatsu Clinic Nishiyama K Prog. Med. 2015; 35(9): 1507-1513

461 Usefulness of long-acting exenatide for older diabetic patients with mild cognitive impairment

Kakeyu-Misayama rehabilitation center

Tohyoh S Therapeutic Research 2015; 36(5): 497-502

462 Efficacy and safety of anagliptin add to insulin therapy in Japanese patients with type 2 diabetes

Kawasaki Medical School

Internal Medicine I Kaku K Jpn Pharmacol Ther 2015; 43(12): 1663-1686

463 Efficacy of vildagliptin in patients with type 2 diabetes treated with insulin on glycemic control: Investigation involving switching from another oral hypoglycemic agent

Keio University Endocrinology, Metabolism and Nephrology

Tanaka M Prog. Med. 2016; 36(2): 277-282

464 The pattern of glycemic variability in patients treated with faster-acting insulin*

JCHO Kanazawa Hospital

Internal Medicine Furukawa K Medical Consultation & New Remedies 2016; 53(2): 98-99

465 Efficacy and safety of anagliptin as an add-on to glinides in Japanese patients with type 2 diabetes

Kawasaki Medical School

Internal Medicine I Kaku K Jpn Pharmacol Ther 2016; 44(3): 381-390

466 Relationship of glycemic control markers- 1,5 anhydroglucitol, fructosamine, and glycated hemoglobin among Asian Indians with different degrees of glucose intolerance

Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialities Centre

Aravindakshan T

Indian Journal of Endocrinology and Metabolism 2016; 20(5):690-695

467 Low and exacerbated levels of 1,5-anhydroglucitol are associated with cardiovascular events in patients after first-time elective percutaneous coronary intervention

Juntendo University Graduate School of Medicine

Cardiovascular Medicine Takahashi S Cardiovascular Diabetology 2016; 15: 145

468 Impact of glycemic control with sitagliptin on the 2-year progression of arterial stiffness: a sub-analysis of the PROLOGUE study

Tokyo Medical University

Cardiology Tomiyama H Cardiovascular Diabetology 2016; 15: 150

469 Safety and efficacy of liraglutide treatment in Japanese type 2 diabetes patients after acute myocardial infarction: A non-randomized interventional pilot trial

Saiseikai Kumamoto Hospital

Cardiology Kajiwara M Journal of Cardiology 2017; 69(3): 511-517

470 Repeated 3-minute stair climbing-descending exercise after a meal over 2 weeks increases serum 1,5-anhydroglucitol levels in people with type 2 diabetes

Toyooka Hospital Hidaka Medical Center

Honda H J Phys. Ther. Sci. 2017; 29: 75-78

471 Efficacy and safety of vildagliptin as an add-on therapy in inadequately controlled type 2 diabetes patients treated with basal insulin

Juntendo University Graduate School of Medicine

Metabolism and Endocrinology

Saito D J Clin Med Res. 2017; 9(3): 193-199

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 472 Cross-over study comparing postprandial glycemic

increase after addition of a fixed-dose mitiglinide/voglibose combination or a dipeptidyl peptidase-4 inhibitor to basal insulin therapy in patients with type 2 diabetes mellitus

National Center for Global Health and Medicine Center Hospital

Endocrinology and Metabolism

Sugiyama N Med Sci Monit Basic Res 2017; 23: 36-44

473 Excretion rates of 1,5-anhydro-D-glucitol, uric acid and microalbuminuria as glycemic control indexes in patients with type 2 diabetes

Xuhui District Central Hospital

Endocrinology Ma C Scientific Reports 2017 [Epub ahead of print]

474 Serum 1,5-anhydroglucitol levels slightly increase rather than decrease after a glucose load in subjects with different glucose tolerance status

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Endocrinology and Metabolism

Su H Acta Diabetol 2017; 54(5): 463-470

475 Effects of 50mg vildagliptin twice daily vs. 50mg sitagliptin once daily on blood glucose fluctuations evaluated by long-term self-monitoring of blood glucose

Hokkaido University Graduate School of Medicine

Rheumatology, Endocrinology and Nephrology

Nomoto H Endocr J. 2017; 64(4): 417-424

476 Serum 1,5-anhydroglucitol levels slightly increase rather than decrease after a glucose load in subjects with different glucose tolerance status

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Endocrinology and Metabolism

Su H J Diabetes Investig 2017; 8(51): 40

477 Glucose peaks and the risk of demantia and 20-year cognitive decline

Johns Hopkins Blooming School of Public Health

Epidemiology Rawlings A Diabetes Care 2017 May [Epub ahead of print]

478 The glucose-lowering efficacy of sitagliptin in obese Japanese patients with type 2 diabetes

Okayama University Hospital

Center for Innovative Clinical Medicine

Kodera R Internal Medicine 2017; 56: 605-613

479 Comprehensive metabolomic analysis in blood, urine, fat and muscle in men with metabolic syndrome: A randomized, placebo-controlled clinical trial on the effects of resveratrol after four months' treatment

Aarhus University Endocrinology and Internal Medicine

Korsholm AS Int. J. Mol. Sci. 2017; 18: 554

480 1,5-Anhydroglucitol correlates with postprandial glucose in subjects with type 1 diabetes irrespective of HbA1c responder status

University of Sheffield

Heller SR Diabetes 2017; 66(Supplement 1): A260-A261

481 Effect of therapy of weekly GLP-1 analog given monthly for elderly type 2 diabetes patients in Japan

Chubu Rosai Hospital Diabetes and Endocrinology

Imamine R Diabetes 2017; 66(Supplement 1): A285-A286

482 Decreased visceral fat and improved insulin resistance together with enhanced urinary glucose excretion may be involved in the serum uric acid-lowering effect of dapagliflozin

Takeda General Hospital

Diabetes Center Hige H Diabetes 2017; 66(Supplement 1): A334-A335

483 HOMA-IR/1,5-AG ratio is a novel parameter for predicting the incidence of type 2 diabetes: The AYABE study

Ayabe City Hospital Endocrinology and Internal Medicine

Senmaru T Diabetes 2017; 66(Supplement 1): A415

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 484 A single dose of dapagliflozin, an SGLT-2 inhibitor,

induces higher glycosuria in GCK- and HNF1A-MODY than in type 2 diabetes mellitus

Jagiellonian University Medical College

Metabolic Diseases Hohendorff J Endocrine 2017; [Published online June]

485 Plasma mannose levels are associated with incident type 2 diabetes and cardiovascular disease

KTH-Royal Institute of Technology

Science for Life Laboratory

Mardinoglu A Cell Metabolism 2017; 26(2): 281-283

486 Information content of paired measurement of A1C and 1,5-anhydroglucitol relative to post-prandial glucose excursions: a model simulation study

Jefferson University Hospitals

Molligan JD Clinical Chemistry 2016; 62(10, Supplement): S44-S45

487 A single dose of dapagliflozin, an SGLT-2 inhibitor, induces higher glycosuria in GCK- and HNF1A-MODY than in type 2 diabetes mellitus

Jagiellonian University Medical College

Hohendorff J Diabetologia 2017; 60(Suppl 1): S132

488 1,5-Anhydroglucitol correlates with postprandial glucose in subjects with type 1 diabetes irrespective of HbA1c responder status

University of Sheffield

Heller S Diabetologia 2017; 60(Suppl 1): S312-S313

489 Efficacy and safety of fast-acting insulin aspart are maintained over 52 weeks: comparison with insulin aspart in onset 1

UZ Leuven Mathieu C Diabetologia 2017; 60(Suppl 1): S314

490 Risk factors for severe hypoglycemia in black and white adults with diabetes: The Atherosclerosis Risk in Communities (ARIC) Study

Johns Hopkins Bloomberg School of Public Health

Epidemiology and the Welch Center for Prevention

Lee AK Diabetes Care 2017; September [Epub ahead on line]

36 M-7-3A

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Screening

No. Title Institute Department First Author Citation

1 Diabetes mellitus and 1,5-anhydro-D-glucitol JR Tokyo General Hospital

Internal Medicine Ishii S The Journal of Japan Physicians Association 1990; 4(3): 329-330

2 Comparison of 1,5-anhydroglucitol, HbA1c, fructosamine for detection of diabetes mellitus

University of Teikyo Internal Medicine Yamanouchi T Diabetes 1991; 40(1): 52-57

3 Combination assay of 1,5-anhydro-D-glucitol with fasting blood glucose, HbA1c and fructosamine as a screening for diabetes mellitus

JR Tokyo General Hospital

Internal Medicine Ishi S J. of Transportation Med. 1991; 45(3): 99-104

4 Assay of 1,5-Anhydroglucitol for screening for diabetes* Tohoku Kouseinenkin Hospital

Internal Medicine Goto Y Diabetes Frontier 1992; 3(4): 403-406

5 Efficacy of hemoglobin A1c, fructosamine and 1,5-anhydroglucitol as screening tests for diabetes in local communities*

Jichi Medical University Public Health Nagai M Japanese Journal of Public Health 1993; 40(3): 205-212

6 Is serum anhydroglucitol an alternative to the oral glucose tolerance test for diabetes screening?

Human Diabetes and Metabolism Research Centre

Robertson DA Diabetes Medicine 1993; 10(1): 56-60

7 Relationship between multiple diagnosis of diabetes and physical risk in island population*

Nagasaki University Public Health Sueda H Nagasaki Medical Journal 1993; 68(2): 231-242

8 preliminary of screening for diabetes using 1,5-anhydroglucitol*

Fukuoka Kuroki Health Center

Tomooka Y The Journal of Public Health Practice 1993; 57(12): 890-892

9 A study of 1,5-anhydroglucitol as a marker in screening diabetes mellitus

Kameda General Hospital

Clinical Laboratory Noto K Official Journal of the Japanese Society of Human Dry Dock 1993; 8(2): 31-34

10 Improvement of the sensitivity of glucose intolerance screening by combining 1,5-AG, hemoglobin A1c and fasting blood glucose

Mitsui Memorial Hospital

Central Clinical Laboratory

Yano M J. Japan Diab. Soc. 1995; 38(4): 255-260

11 Significance of 1,5-Anhydroglucitol in total health check - Usefulness in the screening of diabetes mellitus and effect of renal dysfunction on it -

Aichi Health Center Tsushita K Japanese Journal of Multiphasic Health Testing and Service 1994; 21(2): 118-122

12 Significance of serum 1,5-anhydroglucitol measurements for screening of diabetes mellitus in human dry dock

Kyoto Second Red Cross Hospital

Internal Medicine Okajima Y Official Journal of the Japanese Society of Human Dry Dock 1993; 8(1): 63-66

13 Diagnostic significance of plasma 1,5-anhydroglucitol measurement in screening for diabetes mellitus

Fukushima Medical College

Internal Medicine Nemoto T J. Japan Diab. Soc. 1995; 38(12): 921-929

14 Comparison of 1,5-anhydroglucitol, HbA1c, fructosamine for screening of diabetes mellitus

Keio University Preventive Medicine and Public Health

Miyakawa M Health Science 1996; 12(1): 44-53

15 Efficacy of hemoglobin-A1c, fructosamine and 1,5-anhydroglucitol in screening for diabetes mellitus

Tochigi Public Health Service Association

Nagashima Y Journal of Preventive Medicine 1994; 294: 42-46

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

16 Effect of age and obesity on glycated haemoglobin and 1,5-anhydroglucitol in screening for type 2 diabetes mellitus

Gunma University School of Medicine

Laboratory Medicine

Tsukui S Diabetes Medicine 1995; 12: 899-903

17 Improvement the accuracy of screening tests for diabetes mellitus with a logistic regression model

Gunma University School of Medicine

Laboratory Medicine

Tsukui S J. Japan Diab. Soc. 1996; 39(4): 241-246

18 Screening of glucose intolerance with fasting blood samples Mitsui Memorial Hospital

Internal Medicine Siba T Japanese Journal of Clinical Medicine 1996; 54(10): 2800-2806

19 Decreased serum 1,5-anhydroglucitol in nondiabetic subjects with a family history of NIDDM

Gunma University School of Medicine

Laboratory Medicine

Tsukui S Diabetes Care 1996; 19(9): 940-944

20 Efficacy of 1,5-anhydroglucitol in screening for impaired glucose tolerance*

Saiseikai Matsuyama Hospital

Clinical Laboratory Yamauchi M The Ehime Journal of Medical Technology 1997; 16: 47-49

21 Screening of glucose intolerance with fasting blood samples Mitsui Memorial Hospital

Internal Medicine Siba T Japanese Journal of Clinical Medicine 1997; 55(Special Edition 1997): 904-909

22 Economic evaluation of alternative indicator for screening for diabetes mellitus

Keio University Preventive Medicine and Public Health

Sirasaya K Preventive Medicine 1999; 29: 79-86

23 Study on cut-off point of 1,5-anhydroglucitol Aichi Health Center Yamamoto K Japanese Journal of Multiphasic Health Testing and Service 1999; 26(3): 241-245

24 Diagnosis and tests for impaired glucose tolerance and borderline type

Hiroshima Atomic Bomb Casualty Council

Health Management & Promotion Center

Ito C Japanese Journal of Clinical Medicine 2005; 63(Special Edition 2): 355-360

25 Plasma anhydro-D-glucitol Hiroshima Medical Association Clinical Laboratory Center

Maeda R Japanese Journal of Clinical Medicine 2005; 63(Special Edition 2): 386-389

26 Diagnosis and tests for diabetes mellitus Hokkaido University School of Medicine

Internal Medicine Niwa H KLINIKA 2004; 31(6): 384-389

27 Screening method for postprandial hyperglycemia using 1,5-anhydroglucitol combined with fasting plasma glucose

Foundation of Kinki Health Administration Center

Shiga Department Clinic

Kanazawa Y J. Japan Diab. Soc. 2006; 49(5): 319-323

28 Effective screening method and follow-up for diabetes mellitus*

Hiroshima Atomic Bomb Casualty Council

Health Management & Promotion Center

Ito C Diabetes Up date 2006; 22: 20-29

29 6. Health checkup・Screening for glucose intolerance in ningen dock checkup*

Jikei University School of Medicine

Wada T Prog. Med. 2006; 26(9): 2097-2100

30 Study using random allocation on the long-term effectiveness of short-term health education programs for prevention of diabetes in middle-aged and elderly subjects

Iwate Medical University

Hygiene and Preventive Medicine

Itai K Health management association research grant bulletin 2007; 23: 9-14

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

31 Screening method for postprandial hyperglycemia using 1,5-anhydroglucitol in order to discover subjects with postprandial hyperglycemia in Ningen Dock

Foundation of Kinki Health Administration Center

Shiga Department Clinic

Kanazawa Y Official Journal of Japan Society of Ningen Dock 2008; 23(3): 570-574

32 Screening for type 2 diabetes in obese youth Univ. Texas Southwestern Medical Center

Pediatrics Shah S Pediatrics 2009; 124: 573-579

33 Efficacy of 1,5-anhydroglucitol in screening for diabetes mellitus*

Asahi General Hospital Central Clinical Laboratory

Hiiro J The Medical Journal of Asahi General Hospital 2009; 31: 10-13

34 Question: Efficacy of markers for screening for prediabetes* Yokkaichi Social Insurance Hospital

Clinical Laboratory Kato M Obesity & diabetes 2011; 10(4): 541-544

35 Are current diagnostic guidelines delaying early detection of dysglycemic states? Time for new approaches

NYU School of Medicine

Bergman M Endocrine 2013; 44(1): 66-69

36 Relationship between serum 1,5-AG levels and macrovascular disease (coronary heart diseases, strokes) in Suita study*

Keio University Preventive Medicine and Public Health

Okamura T Study Report 2013: 53-60

37 Usefulness of postmortem 1,5-anhydroglucitol analysis in forensic diagnosis

Ehime Prefectural University of Health Sciences

Medical Technology

Takaya T Japanese Journal of Medical Technology 2014; 63(6): 680-686

38 Diabetes screening in the workplace by a single casual blood sampling using HbA1c, fructosamine and 1,5-AG: An application of stepwise regression analysis

Hokkaido Chuo Rosai Hospital

Kaji H J. Nor. Occ. Health 2013; 49: 23-28

39 Measurement of postmortem 1,5-anhydroglucitol in vitreous humor for forensic diagnosis

Ehime Prefectural University of Health Sciences

Medical Technology

Takata T J Forensic Sci. 2016; 61(Suppl 1): S150-S153

40 Rational diagnosis of diabetes: the comparison 1,5-anhydroglucitol with other glycemic markers

Ufuk University Internal Medicine Malkan UY SpringerPlus 2015; 4: 587

41 Obesity-related metabolite profiles of black women spanning the epidemiologic transition

Loyola University Chicago

Public Health Sciences

Dugas LR Metabolomics 2016; 12: 45

42 Serum 1,5-anhydroglucitol level as a screening tool for diabetes mellitus in a community-based population at high risk of diabetes

Zhongda Hospital Southeast University

Endocrinology Wang Y Acta Diabetol 2016 November [E-pub ahead of print]

43 The establishment of biological reference intervals of nontraditional glycemic markers in a Chinese population

The Second Affiliated Hospital of Anhui Medial University

Clinical Laboratory Zhou Q J Clin Lab Anal 2016; 1-7

44 Serum 1,5-anhydroglucitol when used with fasting plasma glucose improves the efficiency of diabetes screening in a Chinese population

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Endocrinology and Metabolism

Ying L Sci Rep. 2017 ; 7(1): 11968

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Pediatrics

No. Title Institute Department First Author Citation

1 1-Deoxyglucose (1,5-Anhydroglucitol); A novel metabolic parameter of diabetes*

National Defense Medical College

Pediatrics Yoshioka S Pediatrics of Japan 1983; 24(4): 405-410

2 1-Deoxyglucose (1,5-Anhydroglucitol), Sorbitol (Glucitol) National Defense Medical College

Pediatrics Fujitsuka S Japanese Journal of Pediatric Medicine 1990; 22(2): 211-216

3 Usefulness of determination of serum 1,5-anhydroglucitol in screening for diabetes mellitus in children

Niigata University Pediatrics Asami T The Journal of Child Health 1991; 50(3): 389-391

4 Clinical significance of 1,5-anhydroglucitol in children with diabetes mellitus*

Nihon University Hospital

Pediatrics Urakami T The Journal of Pediatric Practice 1992; 55(3): 448-451

5 Clinical significance of SMBG and 1,5-anhydroglucitol for glycemic control in children with insulin-dependent diabetes mellitus*

Nihon University Hospital

Pediatrics Urakami T Self measurement of blood glucose and management of diabetes 1992; 10th Symposium: 59-63

6 Screening and diagnosis for diabetes mellitus in children* Osaka Rosai Hospital Pediatrics Konishi K The Journal of Pediatric Practice 1993; 56(8): 1522-1527

7 Education of glycemic control* Nihon Medical University

Pediatrics Ooki Y The Journal of Pediatric Practice 1993; 8(77): 1551-1557

8 Study on serum concentration and urinary excretion of 1,5-anhydro-D-glucitol in children with insulin-dependent diabetes mellitus

National Defense Medical College

Pediatrics Fujitsuka S J Jpn Pediatr Soc 1993; 97(6): 1360-1372

9 Evaluation of serum 1,5-Anhydro-D-glucitol in children with diabetes mellitus

Osaka Medical College Pediatrics Tokuda M Clinical Endocrinology 1992; 40(9): 869-873

10 Reliability of 1,5-Anhydro-D-glucitol as a Marker for Detection of Diabetes and an Indicator of Glycemic Control in Insulin-dependent Diabetes Mellitus Children

Nihon University Pediatrics Urakami T Clin Pediatr Endocrinol 1995; 4(1): 25-31

11 Study on polyol metabolism in children with insulin dependent diabetes mellitus*

Hiroshima University School of Medicine

Pediatrics Jinno K Hiroshima M.J. 1998; 46(3,4): 99-106

12 Urinary glucose screening for diabetes mellitus in Kumamoto city - Results and problems over the past 24 years -

Kumamoto University School of Medicine

Pediatrics Kiwaki K J Jpn Pediatr Soc 2001; 105(2): 94-99

13 The associaiton between Juvenile obesity and 1,5-Anhydroglucitol(1,5AG)

Jikei University School of Medicine

Diabetes, Metabolism and Endocrinology

Miyashita Y Diabetes 2007; 50(supple1): S237

14 Serum 1,5-anhydroglucitol (Glycomark TM) levels in children with and without type1 diabetes mellitus

Clinical Care Center Pediatric Nguyen TM Pediatr. Diabetes 2007; 8(4): 214-219

15 Education of diabetes for 7 years-old-girl with type 1 diabetes* National Center for Global Health and Medicine

pharmacology Kanazawa N The Pharmaceuticals 2011; 53(6): 869

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

16 Evaluation of 1,5-anhydroglucitol, hemoglobin A1c, and glucose levels in youth and young adults with type 1 diabetes and healthy controls

Joslin Diabetes Center Pediatric Mehta SN Pediatric Diabetes 2011; 13: 278-284

17 Metabolomic profiles predicting type 1 diabetes Wittmann B Diabetes 2012; 61(SUPPL1): A367

18 The interrelationships of glycemic control measures: HbA1c, glycated albumin, fructosamine, 1,5-anhydroglucitol, and continuous glucose monitoring

Jaeb center for health research

Laboratory Medicine

Beck R Pediatric Diabetes 2011; 12: 690-695

19 Glycemic control indicators in patients with neonatal diabetes mellitus

Asahikawa Medical University

Pediatrics Suzuki S World J Diabetes 2014; 5(2): 198-208

20 Screening for type 2 diabetes and prediabetes in obese youth: evaluating alternate markers of glycemia - 1,5-anhydroglucitol, fructosamine, and glycated albumin

Children's Hospital Colorado

Pediatrics Chan CL Pediatric Diabetes 2016; 17: 206-211

21 Body mass index and indicators of adiposity are adversely associated with cardiovascular biomarkers in youth with type 1 diabetes over 18 months

NICHD Lipsky LM Circulation 2015; 131: AP135

22 1,5-anhydroglucitol, a discriminatory gas chromatography-mass spectrometry(GC-MS) metabolomic marker in adolescents with type 1 diabetes- quantified using the plasma Glycomark assay

Lady Cilento Children's Hospital

Endocrinology Conwell LS Pediatric Diabetes 2015; 16(Suppl. 21): 41-42

23 Value of serum 1,5-anhydroglucitol measurements in childhood obesity in the continuum of diabetes

Konkuk University Medical Center

Pediatrics Yoo HY Ann Pediatr Endocrinol Metab 2015; 20: 192-197

24 Greater diet quality is associated with more optimal glycemic control in a longitudinal study of youth with type 1 diabetes

Ennice Kennedy Shriver national Institute of Child Health and Human Development

Health Behavior Branch

Nansel TR Am J Clin Nutr 2016; 104(1): 81-87

25 Alternate glycemic markers reflect glycemic variability in continuous glucose monitoring in youth with prediabetes and type 2 diabetes

Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

Pediatric Endocrinology

Chan CL Pediatr Diabetes 2016; : 1-8

26 Physical activity (PA) in youth with type 1 diabetes (T1D): variable impact on metabolic outcomes

Joslin Diabetes Center Pediatric, Adolescent and Young adult section

Giani E Pediatric Diabetes 2016; 17(Suppl. 24): 148

27 Glycemic control and variability in association with body mass index and body composition over 18 months in youth with type 1 diabetes

Eunice Kennedy Shriver national Institute of Child Health and Human Development

Health Behavior Branch

Lipsky LM Diabetes Res Clin Pract 2016; 120: 97-103

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Pregnancy

No. Title Institute Department First Author Citation

1 1-Deoxyglucose (1,5-anhydro-D-glucitol) concentration during pregnancy and puerperium

Kurume University School of Medicine

Obstetrics Gynecology

Nakayama Y ACTA OBST GYNAEC JPN 1987; 39(9): 1657-1658

2 Serum levels of 1,5-anhydro-D-glucitol during the normal and diabetic pregnancy and puerperium

Kurume University School of Medicine

Obstetrics Gynecology

Tetsuo M Acta Obset Gynecol Scand 1990; 69: 479-485

3 Efficacy of 1,5-Anhydro-D-glucitol in screening for gestational diabetes mellitus*

Kurume University School of Medicine

Obstetrics Gynecology

Yoshimatsu K Practice 1991: 18-26

4 Clinical significance of 1,5-anhydroglucitol in pregnant women with normal and abnormal glucose tolerance*

Asahikawa Medical University

Obstetrics Gynecology

Sasaki K The World of Obstetrics and Gynecology 1992; 44(2): 17-22

5 Serum 1,5-anhydroglucitol (1,5-AG) in pregnant diabetic Tokyo Women's Medical College

Diabetes Center Sanaka M J. Japan Diab. Soc. 1993; 36(2): 93-100

6 Fetal and maternal 1,5-anhydroglucitol (1,5-AG) in pregnant rats Part II: Distribution of 1,5-AG in normal pregnant rats

Tokyo Women's Medical College

Internal Medicine Morita Y J Tokyo Wom Med Univ 1993; 63(2): 64-69

7 Serum 1,5-anhydroglucitol (1,5-AG) in pregnant diabetics at delivery and in cord serum

Tokyo Women's Medical College

Diabetes Center Sanaka M J. Japan Diab. Soc. 1993; 36(2): 93-100

8 Fetal and maternal 1,5-anhydroglucitol (1,5-AG) in pregnant rats Part I: Alteration of serum 1,5-AG in normal pregnant rats

Tokyo Women's Medical College

Internal Medicine Morita Y J Tokyo Wom Med Univ 1993; 63(2): 191-195

9 Efficacy of 1,5-anhydroglucitol (AG) in management for gestational diabetes mellitus*

Hirosaki University School of Medicine

Obstetrics Gynecology

Tanaka M Practice 1991: 41-47

10 Disorders of carbohydrate metabolism Mie University School of Medicine

Obstetrics Gynecology

Toyoda N Journal of Clinical Laboratory Medicine 1997; 41(7): 783-787

11 Application of GC/MS analysis of urinary sugar and sugar-alcohols to the clinical management of pregnant woman with abnormal carbohydrate metabolism

Tetsuo Hospital Tetsuo M Proceedings of the Japanese Society for Biomedical Mass Spectrometry 1998; 23: 89-93

12 The predictive value of serum 1,5-anhydro-D-glucitol in pregnancies at increased risk of gestational diabetes mellitus and gestational impaired glucose tolerance

The Chinese Univ of HongKong

Obstetrics and Gynaecology

Wing-Hung Tam

Br J Obstet Gynaecol 2001; 108: 754-756

13 Plasma anhydro-D-glucitol(1,5-AG) as an indicator of hyperglycaemic excursions in pregnant women with diabetes

Poznan University of medical

Pharmacology M. Dworacka Diabetic Medicine 2005; 23: 171-175

14 Evaluation of 1,5-anhydroglucitol as marker of glycemic control and birth weight in pregnancy complicated by type 1 diabetes mellitus

Nowak N Diabetes 2012; 61(SUPPL1): A51

15 Metabolomics reveals broad-scale metabolic perturbations in hyperglycemia mothers during pregnancy

Scholtens DM Diabetes 2012; 61(SUPPL1): A340

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

16 1,5-anhydroglucitol (1,5-AG) is strongly associated with neonatal birth weight across all trimesters in pregnancy complicated by diabetes

University of Washington

Medicine/Metabolism Wright L A-C Endocr Rev 2012; 33(03_MeetingAbstract)

17 Interpretation of plasma 1,5-anhydroglucitol in pregnancy using a novel approach to establishing reference change values

Diagnostic Service of Manitoba

Burton TR Clinical Biochemistry 2012; 45(Issues13-14): 1103

18 Evaluation of 1,5-anhydroglucitol as marker of glycaemic control and birth weight in pregnancy complicated by type 1 diabetes mellitus

Jagiellonian University

Metabolic Diseases Nowak N Diabetologia 2012; 55(Suppl1): S437

19 1,5-anhydroglucitol as a marker of maternal glycaemic control and predictor of neonatal birthweight in pregnancies complicated by type 1 diabetes mellitus

Jagiellonian University

Metabolic Diseases Nowak N Diabetologia 2013; 56: 709-713

20 1,5-anhydroglucitol(1,5AG) and neonatal complications in pregnancy complicated by diabetes

Univ. of Washington Endocrinology Wright LA 49th EASD 2013; No.1293

21 Metabolomics reveals broad-scale metabolic perturbations in hyperglycemic mothers during pregnancy

Northwestern University

Feinberg school of Medicine

Scholtens DM Diabetes Care 2014; 37(1): 158-166

22 1,5 Anhydroglucitol serum concentration as a biomarker for screening gestational diabetes in early pregnancy

Federal University of Parana

Clinical Analysis Boritza KC Clin Chem Lab Med 2014; 52(8): e179-e181

23 1,5-anhydroglucitol as a marker of maternal glycaemic control and predictor of neonatal birthweight in pregnancies complicated by type 1 diabetes mellitus

Jagiellonian University

Metabolic Diseases Nowak N Diabetes Technology & Therapeutics 2014; 16(SUPPL.1): S72

24 1,5 Anhydroglucitol and neonatal complications in pregnancy complicated by diabetes

University of Washington Medical Center

Wright LA Endocr Pract. 2015; 21(7): 725-733

25 1,5-Anhydroglucitol: a new predictor of neonatal birth weight in diabetic pregnancies

University of Washington

Obstetrics & Genecology

Delaney SS Eur J Obstet Gynecol Reprod Biol. 2015; 189: 55-58

26 The early bird catches the worm - predicting the onset of gestational diabetes in the first trimester

Rotunda Hospital Obstetrics & Genecology

Corcoran S J Matern Fetal Neonatal Med 2015; 28(7): 823-824

27 Epidemiology of dysglycemia in pregnant Oklahoma American Indian women

University of Oklahoma Health Sciences Center

Endocrinology Azar M J Clin Endocrinol Metab 2015; 100(8): 2996-3003

28 Indicators of glycemic control in patients with gestational diabetes mellitus and pregnant women with diabetes mellitus

NTT West Osaka Hospital

Internal Medicine Hashimoto K World J Diabetes 2015; 6(8): 1045-1056

29 Correlation between GlycoMark values as an index of glucose levels in pregnant diabetic women and the rate of clinical diabetic complications in infants

Emek Medical Center Ob & Gyn Nachum Z Am J Obstet Gynecol 2016; 214(Suppl 1): S353-S354

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

30 Low levels of serum 1,5-anhydroglucitol during pregnancy compared to blood glucose measured by continuous glucose monitoring

Kitasato University Health Care Center Moriya T Annals of Clinical & laboratory Science 2016; 46(2): 227-228

31 Metabolomic profiling of second trimester amniotic fluid from mothers with diabetes during pregnancy shows evidence of altered fetal metabolism

Alexander J ADA 2016; 76th

32 The association of glycemic markers with plasma adipocytokine levels in women with gestational diabetes

Istanbul University Endocrinology and Metabolism

Oztop N J Diabetes Metab 2016; 7(9)

33 The relationship between proinflammatory cytokines and glycemic markers in gestational diabetes

Istanbul University Dinccag N Diabetes 2017; 66(Supplement 1): A389

34 Maternal and neonatal outcomes and 1,5-anhydroglucitol in pregnancies complicated by diabetes

University of Washington School of Medicine

Walker CL ADA 2017; 77th

35 A computational model of 1,5-AG dynamics during pregnancy

Broad Institute of MIT and Harvard

Zekavat SM Physiological Reports 2017; 5(16): e13375

44 M-7-3A

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Page 45: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Renal Function

No. Title Institute Department First Author Citation 1 The influence of renal failure on diabetic marker, 1,5-anhydro-

D-glucitol, I. - the relation between 1,5-anhydroglucitol and creatinine in serum levels -

Gunma University School of Medicine

Internal Medicine Kohama T Japanese Journal of Medicine and Pharmaceutical Science 1991; 25(3); 697-701

2 The influence of renal failure on diabetic marker, 1,5-anhydro-D-glucitol, II. - the relation between 1,5-anhydroglucitol and urinary albumin -

Gunma University School of Medicine

Internal Medicine Shimizu M Japanese Journal of Medicine and Pharmaceutical Science 1991; 25(3): 703-706

3 Low serum 1,5-anhydroglucitol concentrations in patients with chronic renal failure

Kanto Teishin Hospital Endocrinology and Metabolism

Harada H J. Japan Diab. Soc. 1991; 34(2): 163-166

4 Plasma 1,5-anhydroglucitol concentration in patients with End-stage renal disease with and without Diabetes mellitus

Osaka City University Medical School

Internal Medicine Emoto M Nephron 1992; 61: 181-186

5 Fractional excretion of 1,5-anhydroglucitol Ehime University School of Medicine

Internal Medicine Murakami T J. Japan Diab. Soc. 1993; 31(1): 59-61

6 Effect of enal function on serum 1,5-anhydroglucitol Toranomon Hospital Renal Center Yokoyama K Kidney and Dialysis 1993; 25(3): 415-417

7 Urinary excretion of 1,5-anhydroglucitol (1,5-AG) in patients with diabetic

Juntendo University School of Medicine

Nephrology Takeuchi K Kidney and Dialysis 1993; 35(6): 993-997

8 Quantification of 1,5-anhydroglucitol in uremic serum by LC/MS

Nagoya University Branch Hospital

Clinical Laboratory Niwa T Proceedings of the Japanese Society for Biomedical Mass Spectrometry 1993; 18: 185-188

9 Serum 1,5-anhydroglucitol concentrations in non-diabetic patients with chronic renal failure

Gifu City Hospital Internal Medicine Noguchi T Annual of Gifu City Hospital 1993; 13: 1-6

10 Guanidinoacetic acid in serum, urine and renal cortex from streptozotocin-induced diabetic rats

Juntendo University School of Medicine

Nephrology Kiyatake I Clinical and Experimental Nephrology 1994; 36(6): 709-714

11 1,5-Anhydroglucitol as a Marker for the Differential Diagnosis of Acute and Chronic Renal Failure

Kanbara Municipal Hospital

Internal Medicine Yamada H Nephron 1996; 73: 707-709

12 Plasma 1,5-anhydro-D-glucitol concentration and its relation to other plasma components in renal failure and renal transplant recipients

The Queen Elizabeth Hospital

Endocrine & Diabetes

Phillipov G Clin. Chim. Acta 1996; 247: 51-58

13 Renal Tubular Function Affects Glycosuria-Related Urinary Excretion of 1,5-Anhydroglucitol

Osaka City University Medical School

Geriatric Medicine Fujisawa T Diabetes Care 1999; 22(5): 863-864

14 Serum concentration and renal handling of 1,5-anhydro-D-glucitol in patients with chronic renal failure

Kansai Medical University

Internal Medicine Shimizu H Ann Clin Biochem 1999; 36: 749-754

15 Markers of glucose tolerance - management of diabetes* Tokyo Women's Medical College

Diabetes Center Inoue A The Japanese Journal of Clinical Dialysis 2005; 21(7): 844-851

16 Glycemic control of diabetes patients or dialysis Okayama University Graduate School of Medicine

Medicine and Clinical Science

Fukuoka K Kidney and Dialysis 2007; 63(5): 649-654

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 17 Hyperglycemia and diabetic renal change in a model of

polyvinyl alcohol bioartificial pancreas transplantation Kyoto University Organ

Reconstruction and Biomaterials

Sakata N Pancreas 2007; 22(5): 602-603

18 Glucose metabolism in diabetic patients with chronic renal failure

Saitama Medical University

Endocrinology and Diabetes

Yamaguchi M Clinical Endocrinology 2008; 56(4): 411-417

19 Question: Relationship between postprandial hyperglycemia and renal tubular function*

Nippon Medical School Internal Medicine Ouchi M Obesity & diabetes 2008; 7(6): 821-823

20 Close relationship between serum concentrations of 1,5-anhydroglucitol and uric acid in non-diabetic male subjects implies common renal transport system

Kinki General Hospital Internal Medicine Koga M Clin Chim Acta. 2009; 410: 70-73

21 Renal failure* Japanese Red Cross Kumamoto Hospital

Chouno M Clinical nursing practice 2010; 31(1): 90-100

22 Serum 1,5-anhydroglucitol concentrations are a reliable index of glycemic control in type 2 diabetes with mild or moderate renal dysfunction

Kangbuk Samsung Hospital

Internal Medicine Kim WJ Diabetes Care 2012; 35: 281-286

23 Use of complementary markers in assessing glycaemic control in patients with diabetes and chronic kidney disease undergoing iron or erythropoiesis stimulating agents

University of Hull Diabetes Konya J Diabetic Medicine 2012; 29(Supp.1): 5-6

24 Use of complementary markers in assessing glycaemic control in people with diabetic kidney disease undergoing iron or erythropoietin treatment

University of Hull Diabetes and Endocrinology

Konya J Diabet Med. 2013; 30(10): 1250–1254

25 Serum uric acid in relation to serum 1,5-anhydroglucitol levels in patients with and without type 2 diabetes mellitus

Nippon Medical School Internal Medicine Ouchi M Clinical Biochemistry 2013; 46(15): 1436-1441

26 Change in urinary N-acetyl-β-D-glucosaminidase levels relevant to postprandial glycemic control conditions in subjects without diabetes mellitus

Nippon Medical School Internal Medicine Ouchi M Clin Chim Acta 2014; 433: 88-92

27 Postprandial glycemic control conditions in relation to urinary N-acetyl-β-D-glucosaminidase in patients with type 2 diabetes mellitus without low glomerular filtration rate

Nippon Medical School Internal Medicine Ouchi M Diabetes technology & therapeutics 2014; 16(1): 41-47

28 Are there better alternatives than haemoglobin A1c to estimate glycaemic control in the chronic kidney disease population?

Ghent University Hospital

Renal division Speeckaert M Nephrol Dial Transplant 2014; 0: 1-11

29 Relationship between serum 1,5-anhydroglucitol, as an indicator of postprandial glycemic control and serum uric acid, considering the renal threshold for glucosuria in the elderly

Nippon Medical School Internal Medicine Ouchi M J Nippon Med Sch 2014; 81(3): 188-189

30 Serum metabolomic profiling and incident CKD among African Americans

University of Texas Health Science Center at Houston

Epidemiology Yu B Clinical Journal of the American Society of Nephrology 2014; 9(8): 1410-1417

31 Glycemic management in ESRD and earlier stages of CKD Joslin Diabetes Center Renal division Williams ME Am J Kidney Dis. 2014; 63(2): S22-S38

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation 32 Association between pulse wave velocity and a marker of renal

tubular damage(N-acetyl-β-D-glucosaminidase) in patients without diabetes

Dokkyo Medical University School of Medicine

Pharmacology and Toxicology

Ouchi M J Clin Hypertens 2015; 17(4): 290-297

33 Metabolite markers of incident CKD risk Massachusetts General Hospital

Nephrology Rhee EP Clin J Am Soc Nephrol 2014; 9(8): 1344-1346

34 Effect of renal function on serum concentration of 1,5-anhydroglucitol in type 2 diabetic patients in CKD stages I-III: a comparative study with HbA1c and glycated albumin

Diabetesinstitut Heidelberg

Clinical Studies Hasslacher C J of Diabetes 2016; 8: 712-719

35 Metabolomics reveals differential changes in the energy generating pathways of the detrusor and urothellium caused by diabetes

Wang Y Journal of Urology 2016; 195(4S supplement): e414

36 Interactions between kidney disease and diabetes: dangerous liaisons

School of Medicine, Pontificia University Católica do Paraná

Pecoits-Fiho R Diabetol Metab Syndr 2016; 8: 50

37 Serum levels of 1,5-anhydroglucitol and risk of incident end-stage renal disease

Johns Hopkins Bloomberg School of Public Health

Epidemiology Rebholz CM Am J Epidemiol. 2017; 186(8): 952-960

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Other Diseases

No. Title Institute Department First Author Citation

1 Clinical significance of serum 1,5-Anhydroglucitol (AG) concentration in patients with liver cirrhosis

Osaka Prefectural Hospital

Gastroenterology and Metabolism

Kanda T Medical Journal of Osaka Prefectural General Hospital 1990; 13(1):15-18

2 A clinical study of 1,5-anhydro-D-glucitol in sera of malignant tumor patients

Saitama Cancer Center

Clinical Laboratories Ishii M Japanese Journal of Medicine and Pharmaceutical Science 1991; 25(3): 691-696

3 Serum 1,5-Anhydroglucitol concentrations in patients with liver cirrhosis

Kanazawa University First Department of Internal Medicine

Yamagishi S J. Japan Diab. Soc. 1992; 35(5): 381-384

4 Clinical significance of serum 1,5-Anhydroglucitol level in liver cirrhosis

Osaka Prefectural Hospital

Gastroenterology and Metabolism

Kanda T J. Japan Diab. Soc. 1992; 35(11): 899-907

5 Clinical significance of HbA1c serum fructosamine and 1,5-AG in diabetic patients complicated with liver cirrhosis

Osaka Prefectural Hospital

Gastroenterology and Metabolism

Kanda T J. Japan Diab. Soc. 1993; 36(11): 847-854

6 Clinical studies of long-term glycemic control markers in patients with chronic liver disease

Fukui-ken Saiseikai Hospital

Internal Medicine Bando Y J. Japan Diab. Soc. 1997; 40(1): 17-24

7 Clinical evaluation of serum 1,5AG levels in patients with liver cirrhosis

Kanazawa University Hospital

Clinical Laboratories Shibayama M Rinsho Byori 1997; 45(12): 1187-1190

8 Treatment of diabetes mellitus complicated with liver cirrhosis Osaka Prefectural Hospital

Gastroenterology and Metabolism

Kanda T Clinic All-Round 1998; 47(6): 1910-1917

9 Polyol Profiles in Down Syndrome National Institute on Aging

Laboratory of Neurosciences

Shetty HU J Clin Invest 1995; 95(2): 542-546

10 Serum 1,5-anhydro-D-glucitol levels in liver cirrhosis Kanazawa University School of Medicine

Biochemistry Yamagishi S Acta Diabetol 1998; 35: 65-66

11 Treatment of diabetes mellitus complicated with liver cirrhosis* Osaka Prefectural Hospital

Gastroenterology and Metabolism

Kanda T medicina 2000; 37(13): 2002-2004

12 Glycemic control marker in diabetes with liver cirrhosis Kawasaki Medical School

Internal Medicine Oomoto K Medical Practice 2000; 17(10): 1755

13 1,5-anhydroglucitol assay does not correlate with oral glucose tolerance test in cystic fibrosis patients

Walter Reed Army Medical Center

Endocrinology Kinnaird KEH Endocr Pract. 2009 Oct 15, 1-10[Epub ahead of print]

14 Effects of thyroid hormone on A1C and glycated albumin levels in nondiabetic subjects with overt hypothyroidism

The Catholic University of Korea

Internal Medicine Kim MK Diabetes Care 2010; 33(12): 2546-2548

15 1,5-Anhydroglucitol levels are low irrespective of plasma glucose levels in patients with chronic liver disease

Kinki Central Hospital Internal Medicine Koga M Annals of Clinical Biochemistry 2011; 48: 121-125

16 Lack of correlation between 1,5-anhydroglucitol assay and oral glucose tolerance test in patients with cystic fibrosis

Walter Reed Army Medical Center

Endocrinology Kinnaird KEH Endocrine practice 2010; 16(2): 167-170

17 Method-dependent HbA1c values in a family with hemoglobin Himeji

Kuma Hospital Nishihara E Clinica Chimica Acta 2011; 412: 1689-1692

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

18 Glycemic variability is an independent prognostic factor for development of hepatic fibrosis in nonalcoholic fatty liver disease

Kochi Medical School Gastroenterology and Hepatology

Ono M Journal of Hepatology 58 (suppl.1), S545, 2013

19 Metabolomics profile of response to supplementation with β-carotene in the alpha-tocopherol, beta-carotene cancer prevention study

National Cancer Institute

Nutritional Epidemiology Branch

Mondul AM Am J Clin Nutr 2013; 98: 488-493

20 Metabolomics in epidemiology: Sources of variability in metabolite measurements and implications

National Cancer Institute

Cancer Epidemiology and Genetics

Sampson JN Cancer Epidemiol Biomarkers Prev. 2013; 22(4): 631-640

21 Glycemic variability is an independent predictive factor for development of hepatic fibrosis in nonalcoholic fatty liver disease

Kochi Medical School Hospital

Gastroenterology and Hepatology

Ochi T Hepatology 2013; 58(4) suppl: 505A

22 Glycemic variability is an independent predictive factor for development of hepatic fibrosis in nonalcoholic fatty liver disease

Kochi Medical School Gastroenterology and Hepatology

Hashiba M PLOS ONE 2013; 8(11): 1-9

23 Metabolome analysis for diagnostic approach to gastroenterological cancer

Kobe University Graduate School of Medicine

Gastroenterology Suzuki M The Cell 2014; 46(3): 107-110

24 Metabolome alteration in critical illness according to vitamin D status: A prospective cohort study

Brigham and Woman's Hospital

Renal Division Christopher K Crit Care Med 2014; 42(12 Suppl.): A1443

25 Biomarker discovery for the pancreatic cancer by the serum metabolomics based on gas chromatography mass spectrometry

Kobe University Gastroenterology Kobayashi T SHIMAZU Review 2014; 70(3,4): 117-121

26 Hyperglycemia in patients with hematologic malignancies The Ohio State University Wexner Medical Center

Endocrinology Healy SJ Curr Diab Rep 2015; 15: 8

27 Searching biomarkers by metabolome analysis* Kobe University Graduate School of Medicine

Metabolomics Research

Yoshida M Sysmex Scientific Seminar 2014; 37th: 39-45

28 Gastroenterological cancer diagnosis by metabolomics-discovery of pancreatic cancer biomarker

Kobe University Graduate School of Medicine

Metabolomics Research

Yoshida M Rinsyo Byori 2015; 63(4): 450-456

29 Plasma metabolite biomarkers for the detection of pancreatic cancer

Shanghai Key Laboratory of Diabetes Mellitus

Translational Medicine

Xie G Journal of Proteome Research 2015; 14(2): 1195-1202

30 Dose-finding quantitative 18F-FDG PET imaging study with the oral pan-AKT inhibitor GSK2141795 in patients with gynecologic malignancies

Imperial College London

Ovarian Cancer Action Research Centre

Gungor H J Nucl Med 2015; 56(12): 1828-1835

31 Urine metabolite profiles predictive of human kidney allograft status

Weill Cornell Medical College in Qatar

Physiology and Biophysics

Suhre K J Am Soc Nephrol 2016; 27(2): 626-636

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

32 Pancreatic cancer screening using a multiplatform human serum metabolomics system

Kobe University Graduate School of Medicine

Gastroenterology Sakai A Biomark. Med. 2016; 10(6): 577-586

33 Potential usefulness of apolipoprotein A2 isoforms for screening and risk stratification of pancreatic cancer

National Cancer Center Research institute

Chemotherapy & Clinical Research

Honda K Biomark. Med. 2016; 10(11): 1197-1207

34 Metabolomics in cancer biomarker research Shanghai Jiao Tong University

Education Key Laboratory of Systems Biomedicine

Wang X Curr Pharmacol Rep 2016; 2: 293-298

35 A potential tool for diagnosis of male infertility: Plasma metabolomics base on GC-MS

Central South University

Research Center of Modernization of Chinese Medicines

Zhou X Talanta 2016; 147: 82-89

36 High fasting insulin concentrations may be a pivotal predictor for the severity of hepatic fibrosis beyond the glycemic status in non-alcoholic fatty liver disease patients before development of diabetes mellitus

Kochi Medical School Gastroenterology and Hepatology

Masuda K Hepatology Research 2016 [Epub ahead of print]

37 Global and targeted metabolomics of synovial fluid discovers special osteoarthritis metabolites

Wenzhou Medical University

Biochemistry Zheng K Hepatology Research 2016 [Epub ahead of print]

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GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

Reviews

No. Title Institute Department First Author Citation

1 1,5-Anhydroglucitol : A Novel Serum Marker for Screening and Monitoring Diabetes Mellitus?

Univ. of Pennsylvania Pathology Anne L. Frattali CLIN.CHEM. 1994; 40(11): 1991-1993

2 Serum 1,5-anhydroglucitol(1,5AG): New clinical marker for glycemic control

Teikyo University Medicine II Toshikazu Yamanouchi

Diabetes Res. Clin. Pract. 1994; 24(Suppl.): 261-268

3 Monitoring glycaemic control in diabetic patients Pharmaceutical Medicine 1996; 10: 69-70

4 Intolerancia glicida y diabetes mellitus en el anciano Sixto FT Geriatrika 1997; 13(1): 41-44

5 Laboratory Diagnosis and Monitoring of Diabetes Mellitus Beth Israel Medical Center

Clinical Chemistry Kenneth Emancipator

American Society of Clinical Pathology 1999; 112(5): 665-674

6 1,5-anhydroglucitol (GlycoMarkTM) as a marker of short-term glycemic control and glycemic excursions

Ohio State Univ. Dungan KM Expert Rev. Mol. Diagn. 2008; 8(1): 9-19

7 Serum 1,5-anhydroglucitol (GlycoMark TM): A short term glycemic marker

Univ. North Carolina Buse JB Diabetes Technology & Therapeutics 2003; 5(3): 355-363

8 American college of endocrinology pre-diabetes consensus conference: Part three

Mount Sinai School of Medicine

Endocrinology Bloomgarden ZT

Diabetes Care 2008; 31(12): 2404-2409

9 Assessing postprandial glucose using 1,5-anhydroglucitol: An integrative literature review

Brigham Young Univ. Nursing Christensen BL J Am Acad Nurse Pract 2009; 21(10): 542-548

10 Difficulties in interpreting HbA1c results Pomeranian Medical Univ.

Homa K Polskie Archiwum Medycyny Wewnetrzne J 2010; 120(4): 148-153

11 Determining Glycemic Control Smith J Advance for nurse practitioners 2010; 17(8): 39-40

12 Beyond hemoglobin A1c - need for additional markers of risk for diabetic microvascular complications

Irl B. Hirsch JAMA 2010; 303(22): 2291-2292

13 The clinical use of hemoglobin A1c Johns Hopkins Univ. Saudek CD J Diabetes Sci Technol 2009; 3(4): 629-634

14 Circulating biomarkers of glycemia in diabetes management and implications for personalized medicine

U.S. Air Force Medical Corps

True MW J Diabetes Sci Technol 2009; 3(4): 743-747

15 Reexaming metrics for glucose control University of Washington

Internal Medicine Rubinow KB JAMA 2011; 305(11): 1132-1133

16 The quest for the perfect biomarker of long-term glycemia: new studies, new trials and tribulations

Harvard Medical Center

Endocrinology Joo-Pin Foo Metabolism Clinical and Experimental 2011; 60: 1651-1654

17 The roles of glycated albumin as intermediate glycation index and pathogenic protein

Yonsei University Health System

Kim KJ Diabetes Metab J 2012; 36: 98-107

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Page 52: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

18 The challenge of the use of glycemic biomarkers in diabetes: Reflecting on Hemoglobin A1C, 1,5-Anhydroglucitol, and the glycated proteins Fructosamine and Glycated Albumin

Nutrition at the University of Washington

Metabolism, Endocrinology

Wright L.A.-C Diabetes Spectrum 2012; 25(3): 141-148

19 Predicting outcomes and assessing control with alternate glycemic markers

Ohio State University Endocrinology Dungan KM Diabetes Technology & Therapeutics 2012; 14(9): 749-752

20 1,5-Anhydroglucitol in diabetes mellitus Gangneung Asan Hospital

Endocrinology and Metabolism

Kim WJ Endocrine 2013; 43: 33-40

21 Glucose variability Mayo Clinic the Mayo College of Medicine

Service FJ Diabetes 2013; 62(5): 1398-1404

22 Capsule commentary on radin, pitfalls in hemoglobin A1c measurement: When results may be misleading

University of California San Francisco

San Francisco VA Medical Center

Kenneth R J Gen Intern Med 2014; 29(2): 363

23 Glycated albumin - more than the missing link in the evaluation of diabetes control

University of Medicine and Pharmacy Craiova

Dinu IR Rom J Diabetes Nutr Metab Dis. 2014; 21(2): 137-150

24 1,5-anhydroglucitol and glycated albumin in glycemia Municipal Kawanishi Hospital

Diabetes and Endocrinology

Koga M Advances in Clinical Chemistry 2014; 64: 269-301

25 Beyond HbA1c and glucose: the role of nontraditional glycemic markers in diabetes diagnosis, prognosis, and management

Johns Hopkins University

Epidemiology Parrinello CM Curr Diab Rep 2014; 14: 548-557

26 Efficacy of voglibose in type 2 diabetes Kawasaki Medical School

Internal Medicine Kaku K Expert Opin. Pharmacother. 2014; 15(8): 1181-1190

27 Glycemic variability: Clinical implications Medwin Hospital Endocrinology Krishna SVS Indian J Endocrinol Metab. 2013; 17(4): 611-619

28 Voglibose: An alpha glucosidase inhibitor Medical College and Sir Sayajirao General Hospital

Medicine Dabhi AS Journal of Clinical and Diagnostic Research 2013; 7(12): 3023-3027

29 Post-prandial hyperglycaemia Indraprastha Apollo Hospital

ACODE Jindal R JIACM 2013; 14(3-4): 242-246

30 Optimizing diabetes management: Comprehensive analysis of glucose monitoring data and use of better metrics for glycemic control

Institute of Diabetes Kohnert KD Biology. Medicine. Geography Series 2013; 4(72): 6-15

31 Overview of current and upcoming strategies implied for the therapy of type 2 diabetes mellitus

Amity University Rajasthan

Amity Institute of Biotechnology

Choudhury SR Current Diabetes Reviews 2014; 10(4): 275-282

32 Short-term intensive insulin therapy at diagnosis in type 2 diabetes: plan for filling the gaps

Sun Yat-sen University of Medical Science

Guangdong Provincial Key Laboratory of Diabetology

Weng J Diabetes Metab Res Rev 2014; [Epub ahead of print]

52 M-7-3A

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Page 53: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

33 Diet and glycaemia: the markers and their meaning. A report of the unilever nutrition workshop

Unilever R&D Alssema M British Journal of Nutrition 2015; 113: 239-248

34 Sodium glucose cotransporter 2 inhibitors Washington State University

Pharmacotherapy White Jr JR Med Clin N Am 2015; 99: 131-143

35 Early phase metabolic research with reference to special populations

Procil Institute for Clinical Research

Morrow LA Translational Research Method for Diabetes, Obesity and Cardiometabolic Drug Development 2015: 225-242

36 Glycemic variability and oxidative stress: A link between diabetes and cardiovascular disease ?

Keio University School of Medicine

Internal Medicine Saisho Y Int. J. Mol. Sci. 2014; 15: 18381-18406

37 Monitoring glycemia in diabetes The Ohio State University Wexner Medical Center

Endocrinology Healy SJ Med Clin N Am 2015; 99(1): 35-45

38 Utility of different glycemic control metrics for optimizing management of diabetes

Institute of Diabetes Kohnert KD World J Diabetes 2015; 6(1): 17-29

39 Amadori albumin in diabetic nephropathy Rajiv Gandhi Center Diabetes and Endocrinology

Neelofar K Indian J Endocrinol Metab. 2015; 19(1): 39-46

40 Insulin initiation: bringing objectivity to choice Bharti Hospital Kalra S Journal of Diabetes & Metabolic Disorders 2015; 14: 17

41 Alternative biomarkers for assessing glycemic control in diabetes: fructosamine, glycated albumin, and 1,5-anhydroglucitol

Inha University Hospital

Pediatrics Lee JE Ann Pediatr Endocrinol Metab. 2015; 20(2): 74-78

42 Glycemic variability: How do we measure it and why is it important ?

Dong-A Medical Center

Endocrinology and Metabolism

Suh S Diabetes Metab J 2015; 39: 273-282

43 Impact of carbohydrates on weight regain University Hohenheim Nutrition Medicine Bosy-Westphal A

Curr Opin Clin Nutr Metab Care 2015; 18(4): 389-394

44 Ethnicity considerations in diagnosing glucose disorders The Alfred Hospital Hare MJL Current Diabetes Reviews 2016; 12(1): 51-57

45 The utility and pitfalls of the currently used measures of glycaemia in the diagnosis and management of diabetes mellitus

Vardhman Mahavir Medical College

Medicine Sharma BD JIACM 2015; 16(3-4): 227-235

46 Glycemic variability and diabetes complications: Does it matter? Of course it dose!

University of Washington School of Medicine

Hirsch IB Diabetes Care 2015; 38(8): 1610-1614

47 Update on pre-diabetes: Focus on diagnostic criteria and cardiovascular risk

University of Catania Clinical and Experimental Medicine

Pino AD World J Diabetes 2016; 7(18): 423-432

53 M-7-3A

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Page 54: GlycoMark Compendium of Evidence

GlycoMark Compendium of Evidence

The GlycoMark test is FDA-cleared for intermediate monitoring of glycemic control in people with diabetes. Please note that these studies may involve findings that discuss indications that are more specific than or beyond those currently cleared by the FDA for the GlycoMark test. This scientific information is NOT presented to make promotional claims about the GlycoMark test. The intent of providing this information is to disseminate the scientific literature currently available about the GlycoMark test. Please read these studies to understand the strengths and limitations of the data. Should you have questions please contact GlycoMark Regulatory Affairs at (888) 744-0221 or [email protected].

No. Title Institute Department First Author Citation

48 Metrics beyond hemoglobin A1C in diabetes management: Time in range, hypoglycemia, and other parameters

University of Washington Medical Center

Medicine Wright L.A.-C Diabetes Technology & Therapeutics 2017; 19(Supplement 2): S16-S26

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