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The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)

No. 34 May 2004

CCOHTA

P R E -A S S E S S M E N T

Before CCOHTA decides to undertake a health technology assessment, a pre-assessment of the literature is performed. Pre-assessments are based on a limited literature search; they are not extensive, systematic reviews of the literature. They are provided here as a quick guide to important, current assessment information on this topic. Readers are cautioned that the pre-assessments have not been externally peer reviewed.

Introduction Diabetes is prevalent in 5% of the Canadian population.1 Type 2 non-insulin dependent diabetes mellitus (NIDDM) accounts for 85% to 90% of patients with diabetes mellitus. Patients with diabetes have an increased risk for developing complications from cardiovascular (i.e., heart, cerebrovascular and peripheral vascular) disease including neuropathy (leading to limb amputation), retinopathy (leading to blindness) and nephropathy (leading to dialysis and transplant). The clinical management of diabetes ranges from surveillance and primary prevention (preventing disease occurrence) to secondary prevention and management of complications. Regular treatment and the measurement of blood lipid parameters, blood pressure and glycemia used to modify treatment plans are encouraged in patients with type 1 (insulin-dependent) or type 2 diabetes (Figure 1).1

Figure 1: Diagnosis and care of diabetes based on glycemic control

Type 1 or type 2 diabetes

Glycemic control

Complications or death

1. What is the evidence that improved glycemic control delays or leads to fewer complications

2. What is the evidence that testing leads to improved glycemic control?

Management of Diabetes

Diagnosis and screening

HbA

Fructosamine

Fasting plasma glucose

Testing:

Lifestyle – physical nutritional, and disease knowledge education

Antihyperglycemic medications

Treating:

Type 1 or type 2 diabetes

Diagnosis and screening

HbA1c

Fructosamine

Glucose in blood or plasma

Testing

Lifestyle – physical nutritional, and disease knowledge education


Treating: Education about lifestyle, nutrition and disease


Treating

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P R E -A S S E S S M E N T Tests for glycemia are supposed to help patients maintain glycemic control. These tests include fasting blood and plasma glucose measurements, glycosylated hemoglobin measurements (HbA1c) and fructosamine measurements. Traditionally, HbA1c tests are done in a laboratory and blood glucose tests at home. Point-of-care and home-based tests have been developed for HbA1c and fructosamine testing. At issue is the scientific evidence supporting glucose testing in diabetes. The necessary minimum condition for any test is that its output may cause a change in a patient’s clinical management. The test results must also decrease the probability of disease once a new treatment plan is chosen.2

Research Questions Based on the current recommendations for the diagnosis and management of diabetes: 1) What is the scientific evidence that tests of glycemia lead to reduced or delayed

complications in patients diagnosed with type 1 or type 2 diabetes? If there is evidence that testing of glycemia leads to reduced or delayed complications, what is the optimal frequency of testing?

2 a) What is the scientific evidence that testing leads to improved glycemic control?

In particular, what is the evidence that self-monitoring of blood glucose (SMBG), point-of-care or self-monitoring of glycosylated hemoglobin or fructosamine monitoring in any setting will lead to better glycemic control?

b) If there is evidence that testing leads to improved glycemic control, what is the

optimal frequency? c) What is the evidence that testing results are used to modify lifestyle and

medication therapy for persons with diabetes?

3) What is the evidence that improving glycemic control leads to reduced or delayed complications in individuals diagnosed with type 1 or type 2 diabetes?

Assessment Process

Literature was identified by searching MEDLINE® via PubMed (1966-11 Aug 2003), The Cochrane Library (2003 Issue 3), web sites, clinical practice guidelines and clinical trial registries, according to the Canadian Coordinating Office for Health Technology Assessment’s (HTA) checklist.

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P R E -A S S E S S M E N T Summary of Findings

Approximately 1,500 citations were captured during the electronic search. Citations describing research that focuses on the relevant clinical questions are listed in Tables 1 and 2. Trials and observational studies were captured in this preliminary search.

Research question 1)

What is the evidence that testing leads to reduced or delayed complications or death for individuals diagnosed with type 1 or type 2 diabetes? Response to question 1) None of the randomized controlled trials identified compared testing versus no testing and assessed its impact on complications or death. Research question 2 a) What is the evidence that testing leads to improved glycemic control? In particular, what is the evidence that SMBG, point-of-care or self-monitoring of glycosylated hemoglobin or fructosamine monitoring in any setting will lead to better glycemic control? Response to question 2 a) Several reviews, including two systematic reviews of the evidence from RCTs, were found (Table 1). The authors of one systematic review3 conducted a meta-analysis. In children or adult type 1 diabetics, blood glucose monitoring led to a detectable difference in glycosylated hemoglobin (mean difference 0.57%, 95%CI: 1.073 to 0.061) when compared to urine monitoring. On the contrary, no difference between SMBG and urine glucose was detectable from studies involving type 2 diabetics. Further to this, a significant effect on glycemic control from self-monitoring could not be detected. For type 1, we identified one new RCT and eight previously identified RCTs. Three interrupted time-series, five prospective cohort studies, nine retrospective or cross-sectional studies and three surveys were also identified (Table 2). For type 2, two new RCTs were identified (one ongoing), with eight RCTs that were previously identified. Two non-randomized studies, one interrupted time series, two prospective cohort studies, 11 retrospective or cross-sectional cohort studies and four surveys were identified (Table 3).

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Table 1: Reviews identified for question 2 a)

Citation Type of Report (if known) Conclusions (if known)

Coster, Gulliford, et al. 20003

Systematic review conducted for NCCHTA/NICE

Grimaldi & Sachon 20034

Review Prospective randomized studies are needed to confirm efficiency of SMBG in type 2 diabetes

Goldstein, Little, et al. 20035

Review and guidance

Court 20026 Unknown Kennedy 20017 Review Unknown Norris, Engelgau, et al. 20018

Systematic review of training (which might include SMBG)

Hom 19999 Review Unknown Rindone 199810

Unclear whether this is a review

Halimi 199811 Review Use of SMBG is increasingly recommended by diabetologists and general practitioners, but trials investigating effects of SMBG in NIDDM patients found no benefit for metabolic control or weight loss; we recommend a moderate use of SMBG in NIDDM patients

Faas, Schellevis, et al. 199712

Efficacy of SMBG in NIDDM patients is questionable and should be tested in rigorous high-quality RCT, for which some recommendations are given

Goldstein, Little, et al. 199513

Review Unknown

Goldstein 199414 Review Unknown Patrick, Gill, et al. 199415

Commentary

Wysocki 198916 Review

Blohme 198317

Review

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P R E -A S S E S S M E N T SMBG in type 1 diabetes: Our search revealed one new RCT. Most of the studies identified were cross-sectional cohort studies or surveys. One identified RCT evaluated continuous glucose monitoring as an addition to standard monitoring. Several prospective cohorts were identified; two suggested SMBG can lead to tighter glycemic control (Table 2).

Table 2: Studies of SMBG in type 1 diabetes

Citation Design and Patient Group Results

Ludvigsson & Hanas 200318

RCT of children (n=27) to continued glucose monitoring

HbA1c decreased in unmasked arm (7.70% to 7.31%) after 3 months but not in blind arm (7.75% to 7.65%)

Adams, Mah, et al. 200319

Cross-sectional cohort study of adults (n=4,565)

Lower rates of SMBG associated with lower HbA1c testing frequency and higher HbA1c levels in insulin-dependent

Otieno, Ng'ang'a, et al. 200220

Cross-sectional study (n=?) in Kenyan ambulatory clinic

Morning random blood glucose within usual therapeutic targets of 4 mmol/L to 8 mmol/L predicted good glycemic control (HbA1c≤7.8%) with high sensitivity at the range of 86.3% to 98.4%

Rotchford & Rotchford 200221

Cross-sectional retrospective design (n=253) in South Africa

Blood glucose monitoring not regularly performed and medications rarely modified, mean HbA1c 11.3%

Salardi, Zucchini, et al. 200222

Retrospective cohort (n=28) of CGM users

CGM correlates with HbA1c (r=0.53, p=0.002) and decreased during OL cohort study

Soumerai, Mah, et al. 200223

Quasi-experimental pre-post interrupted time-series design assessing trends two years before and after policy decision to cover

No discernible effect of policy change among insulin-treated patients

Clua Espuny, Puig, et al. 200024

Cost-effectiveness analysis Use of SMBG not cost-effective

Deckers, Hermans, et al. 200125

Adult cohort (n=465) cross-section

Median HbA1c was 8.5% (7.7% to 9.3%); all practised monitoring

Karter, Ackerson, et al. 200126

Survey of 1,160 diabetics 395 SMBG at least three times daily

Frequency of self-monitoring correlated with decreases in HbA1c overall

Levine, Anderson, et al. 200127

Prospective cohort of youths (7 to 16 years old, n=300) in special care

Blood glucose monitoring frequency was sole modifiable predictor of HbA1c (p<0.0001)

Kovatchev, Cox, et al. 200028

Unknown Unknown

Orozco, Laparra, et al. 199929

Unknown Unknown

Evans, Newton, et al. 199930

Diabetes database: type 1 (n=807)

Correlation between reagent strip uptake and glycemic control for 258 patients; 0.7% decrease for every 180 strips used

Cava, Cantos, et al. 199931

Quasi-experimental pre-post assessment of type 1 (n=13) and type 2 (n=72) diabetics

Mean glycemic values reduced compared to previous year

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Strowig & Raskin 199832

Pre-post assessment of intensely treated type 1 diabetics (n=22) using SMBG with storage versus those without

Mean GHb level averaged across all patients during period of memory meter use (6.4%) significantly lower than that during period of meter use without memory (6.9%) (p=0.0004)

Weitgasser, Schnoll, et al. 199833

5-year cohort of type 1 (n=57) diabetics

Frequency of blood glucose measurements increased; HbA1c decreased from 7.3±1.2 to 6.4±1.1% after 5 years (p<0.001).

Buysschaert, Maes, et al. 199734

Retrospective cohort (n=1,200) HbA1C also below 8% (controlled) in 50% of patients using 1,100 to 1,200 strips per year

Nathan, McKitrick, et al. 199635

Retrospective pre-post study based on chart review (type 1 n=94 and type 2 n=137)

Increased frequency of self-monitoring and of insulin injections associated with lower HbA1c in IDDM

Tulokas 199536 Unknown Unknown Ikeda & Tsuruoka 199437

Unknown Results of this study of SMBG revealed that it was useful for prevention of chronic complications and for education of diabetes patients

Starostina 1994 (identified from systematic review3)

RCT (not truly random): urine (n=61) versus blood (n=60) versus control (n=60)

Information not available

Ziegher, Kolopp, et al. 199338

Pre-post cohort (n=80) type 1 Fifty-nine patients (79%) were compliant with SMBG and had better metabolic control than non-compliers (HbA1c: 6.7±1.1% versus 7.5±1.9, p<0.05)

Brinchmann-Hansen, Dahl-Jorgensen, et al. 199239

Prospective cohort with follow-up for seven years

Intensified insulin treatment and home blood glucose monitoring improved concentrations of glycated hemoglobin (HbA1) from 11.2% (2.2%) at start of study to mean of 9.5% (1.5%) over seven years of study (p<0.0001)

Gordon, Semple, et al. 199140

RCT with crossover (n=25); trial arms were four-point profiles on 2 days per week; four-point profiles on 1 day per week; two-point profiles on every day of week

No correlation between frequency at which patients altered insulin doses and measures of metabolic control. Altering frequency of SMBG had variable and uncertain influence on frequency at which patients altered insulin doses

Newman, Laqua, et al. 199041

Retrospective cohort of diabetic patients (n=21) who self-monitored glucose levels (via reflectance meter or visual strips) were compared with 17 closely matched patients

SMBG levels alone did not improve mean amount of glycemia in these patients

Larsen, Petersen, et al. 199042

Prospective cohort of diabetics (n=120) evaluated by physicians without HbA1c measurement

Home blood glucose monitoring did not lead to better agreement between classifications

Table 2 cont’d…

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Lam, Ma, et al. 198643

Chinese type 1 (n=38) cohort divided into poor control (n=27) and regular (n=11) groups

After long-term SMBG, 82% of patients in group B had good control (HbA1≤10%) compared with 45% in group A (p<0.05)

Lombrail, Obadia, et al. 198644

Survey of type 1 diabetics (n=282) who routinely visited clinic

Mean HbA1 at time of visit was not statistically different in patients performing home blood glucose testing only (9.3±2.1%), in patients monitoring blood and urine (9.2±2%) or urine only (9.3±1.7%) and in patients who did not practise self-monitoring (9.5±1.8%)

Daneman, Siminerio, et al. 198545

Double crossover study (n=16) of children to urine plus SMBG or urine alone

No significant differences could be detected between two groups at any stage of study

Terent, Hagfall, et al. 198546

RCT, 18 months, (n=37) randomized to individual formal education followed by SMBG (n=10), instruction in SMBG without pre-education (n=8), only formal education (n=9) and a reference group (n=10)

Education did not improve mean HbA1 values; final HbA1 level, however, did not differ significantly between groups

Mann, Noronha, et al. 198447

CT, 18 months, children receiving intensive education (N=20) or education combined with SMBG (N=19)

HbA1c levels showed seasonal fluctuation, but values at beginning and end of study nearly identical to each other in both groups; SMBG group showed a reduction in number of hospital admissions for stabilization of control and for ketoacidosis (p<0.04)

Carney 1983 (identified from systematic review3)

Cluster randomized trial (n=86) to blood versus urine monitoring

Absolute difference in glycated hemoglobin -0.72 (95% CI -1.40 to 0.04)

Miller 1983 (identified from systematic review3)

RCT (n=19) Absolute difference in glycated hemoglobin -0.40 (95% CI -3.95 to 3.15)

Schiffrin & Belmonte 198248

Crossover RCT? In compliant, motivated young adults with insulin-dependent diabetes, frequent self-glucose monitoring is critical for long-term maintenance of glycemic control

Worth 1982 (identified from systematic review3)

RCT crossover (n=38) of urine monitoring versus SMBG (visual) or SMBG (meter) for 60 weeks

Information not available

Walford, Gale, et al. 197849

Cohort (n=67) of type 1 diabetics Patients found self-monitoring more informative than urine tests; their involvement in management of disease resulted in better motivation

OL=open label; B=blinded; RCT=randomized controlled trial; CGM=continuous glucose monitoring; CT=controlled trial; GHb=glycosylated hemoglobin

Table 2 cont’d…

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SMBG in type 2 diabetes: One new RCT was identified. Its results suggest that SMBG used six times during a day, on two days per week, can have a greater impact than no monitoring in type 2 diabetics who do not require insulin. An intention-to-treat analysis was not done. Retrospective cohort studies have produced mixed results: some have suggested increased testing frequency leads to better glycemic control, while some have suggested the opposite. One retrospective cohort suggested that there was no correlation between glycemic control and SMBG type 2 diabetics who take insulin (Table 3).

Table 3: SMBG in type 2 diabetes

Citation Design Highlighted Conclusions

Farmer 200250 (in progress)

RCT to determine effect of SMBG in people with type 2 diabetes; patients trained to use SMBG

Main outcome is HbA1c with additional measurements of risk factors for cardiovascular disease, satisfaction with care, quality of life and costs of care. Structured interviews to be conducted to identify those most likely to benefit

Hoffman, Shah, et al. 200251

Stable, insulin-treated subjects (n=150, age=67) SMBG using different strategies, cohort study

Twice-daily testing strategies, particularly pre-lunch and pre-dinner, assess glycemic control and capture proportion of out-of-range readings

Ozmen & Boyvada 200352

Cohort of patients without retinopathy (n=140, 52.4%), background retinopathy (n=75, 28.1%) or proliferative retinopathy (n=52, 19.5%) taught to use SMBG

In group without diabetic retinopathy at 6- and 12-month controls, mean HbA(lc) concentration <7%, but in group with diabetic (background and proliferative) retinopathy, value could not be reduced below 7%

Adams, Mah, et al. 200319

Cross-sectional study (n=4,565), adults

Higher HbA1c test frequency associated with more monitoring in oral agents

Ingleby, Trowbrudge, et al. 200253

Cohort study Information not available

Meier, Swislocki, et al. 200254

Retrospective cohort study Similar findings observed in cohort of 421 drug-treated patients with paired HbA1c data before and after (policy decision to decrease SMBG to twice weekly)

Schwedes, Siebolds, et al. 200255

Multi-site RCT (n=250) comparing SMBG 6 times/day 2 times per week versus no SMBG; individuals not on insulin

HbA1c decreased more in SMBG group (1.0% (1.08) versus 0.54 (1.41), p=0.0086)



Among 288 patients who initiated SMBG, HbA1c reduced from 10.8% to 8.6% and frequency rose 34%

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Blonde, Ginsberg, et al. 200256

Unknown Unknown

Harris, 200157 Cross-sectional survey from NHANES

Frequency of self-monitoring correlated with increases in HbA1c overall

Karter, Ackerson, et al. 200126

Survey of 23,412 diabetics; 7,500 SMBG at least once daily with retrospective cohort analysis

Frequency of self-monitoring correlated with decreases in HbA1c overall

Franciosi, Pellegrini, et al. 200158

Survey of 3,567 with retrospective cohort analysis

SMBG associated with higher levels of HbA1c in patients not treated with insulin

Lerman-Garber, Lopez-Ponce, et al. 200159

Longitudinal cohort study (n=60) A bimonthly fasting PG correlated well with the HbA1c and is easiest and cheapest way of monitoring glycemic control in type 2 diabetic patients with some preserved insulin reserve (diabetes for <10 years and on treatment with one hypoglycemic agent)

Evans, Newton, et al. 199930

Retrospective cohort type 2 study (n=790)

No correlation between reagent strip uptake and glycemic control for 290 patients with type 2 diabetes who used insulin

Clua Espuny, Puig, et al. 199960

Retrospective cohort type 2 study (n=597)

41.06% of diabetics practised MBG on stable basis, without significant differences showing in either HbA1c percentage, in any of biological variables defining metabolic control in relation to practice or otherwise of MBG or in its frequency

Schiel, Muller, et al. 199961

Cross-sectional study followed by pre-post cohort study of SMBG plus training

Negative correlation (r=-0.17, p<0.001) between frequency of blood-glucose self-tests/week and HbA1c; after training, daily SMBG statistically associated with better quality of metabolic control

Brewer, Chase, et al. 199862

HbA1c values compared with SMBG measurements in subjects who did at least three blood glucose tests per day over 30 days in three age groups: 5 to 11, 12 to 16 and 17 to 35 years (type 1 diabetes)

Strong correlation (P=0.001) found between HbA1c values and average blood glucose; and with percentage of HBG measurements within, above and below target range in each of three age groups (p<0.001)

Clua Espuny, Queralt Tomas, et al. 199863

Crossover, observational study (n=400)

Direct dispensing of reactive strips led to important annual increase in cost (+46.59%) and consumption (+89.25%), but acceptable effectiveness not demonstrated (1.10%)

Miles, 1997 (identified from systematic review3)

RCT SMBG versus urine monitoring

No difference

Table 3 cont’d…

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Oki, Flora, et al. 199764

Survey (n=98) GHb comparable between testers and non-testers; among testers, no difference in mean GHb values based on frequency of SMBG

Gallichan 1994 (identified from systematic review3)

RCT SMBG versus urine monitoring

No difference

Muchmore, Springer, et al. 199465

RCT; 23 overweight (body mass index 27.5 to 44 kg/m2) patients aged 40 to 75 participated in 28-week behavioral weight control program

HbA1c level showed progressive decline in experimental subjects (p<0.05), whereas there was no improvement in control subjects

Klein, Oboler, et al. 199366

Cross-sectional cohort study (n=200)

Home glucose monitoring, particularly of urine, widely practised; convincing evidence of its value in helping patients improve their blood glucose control or preventing complications of disease is lacking

Allen, DeLong, et al. 199067

RCT (n=54) patients randomized to SMBG or urine testing

Both urine-testing and SMBG groups showed similar improvement in glycemic control; in each group, there were significant improvements in fasting plasma glucose (reduction of 1.4±3.2 mM, P<0.03) and glycosylated hemoglobin (reduction of 2.0±3.4%, p<0.01) levels


Retrospective cohort of diabetics (n=120) evaluated by physicians without HbA1c measurement

Home blood glucose monitoring did not lead to better agreement between classifications of poor, moderate and good glycemic control

Rutten 1990 (identified from systematic review3)

RCT with SMBG versus conventional care

Glycated hemoglobin decrease in intervention group; increase in control group

Estey 1989 (identified from systematic review3)

RCT of telephone calls and home visits leading to greater SMBG

No difference

Fontbonne, Billault, et al. 198968

RCT. Poorly controlled diabetic patients (n=208) were randomized to group A, regular HbA1c determinations but no self-monitoring; group B, self-urine glucose monitoring, twice every other day; group C, SMBG twice every other day; and followed six months

At end of study period, decrease of HbA1c over six months (main end point) was not significantly different among three groups (mean±SEM: group A -0.5±0.2%, group B -0.1±0.3%, group C -0.4±0.3%)

Table 3 cont’d…

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Mercelina, Degenaar, et al. 198969

Cross-sectional cohort study (n=98)

Fasting blood glucose and serum fructosamine values cannot replace HbAlc measurement for monitoring diabetic control

Wing, Epstein, et al. 198670

RCT of obese patients with type II diabetes (n=50) assigned either to standard behavioral weight control program or to weight control program that included SMBG levels and focused on weight to blood glucose relationship.

No evidence that addition of SMBG levels to treatment program improved outcome in terms of weight loss, reduction in medication, dietary compliance or mood state

Wing, Lamparski, et al. 198571

Retrospective cohort study (n=282)

Data suggest that frequency and accuracy of SMBG are independent and that neither ensures good glycemic control

Worth, Home, et al. 198272

RCT crossover study (n=38) Despite patients’ enthusiasm and other reports to contrary, home blood glucose monitoring offered no improvement in control over intensive attention and conventional urine glucose monitoring

PG=plasma glucose

Home or point-of-care glycosylated hemoglobin testing

Types 1 and 2 diabetes: One identified RCT and one prospective cohort study further supported the importance of knowing an HbA1c result. One rapid point-of-care test (called “DCA 2000”) was able to produce 82% of results within a “clinically acceptable” error range, suggesting that laboratory testing might be of more value. Two retrospective and cross-sectional cohort studies and one survey were also identified (Table 4).

Table 3 cont’d…

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Table 4: Studies of home or point-of-care glycosylated hemoglobin testing

(type 1 or 2 diabetes)


Rector, Venus, et al. 200173

Survey of 380 members of a health plan given a POC HbA1c kit

55% did not use the kit

Parkes, Ray, et al. 199974

B-D A1c At-Home test kit was evaluated in a clinical trial using 1,625 dried blood spot samples from 59 subjects diagnosed with type 1 or type 2 diabetes collected in an in-clinic setting

B-D A1c At-Home results, which are highly correlated with the standard Cobas Integra Hemoglobin A1c assay, (r2=94.7%), demonstrate excellent within-subject reproducibility for 3- to 10-day-old samples (coefficient of variation =2.7%) and provide a coefficient of variation =3.9%for among-subjects

Le Marois, Bruzzo, et al. 199675

Retrospective blood sample study (n=103)

Of glycemic levels calculated from DCA values using this formula, 82% fell within a clinically acceptable error range when compared with measured glycemic values

Larsen, Horder, et al. 199076

RCT of 240 patients with IDDM: one group of patients and clinicians knew HbA1c, the other did not

Among 222 patients still being followed after one year, mean HbA1c value decreased significantly from 10.1% to 9.5% (p<0.005) in group whose HbA1c level was monitored (n=115), whereas initial and one-year values in control group (n=107) were 10.0% and 10.1% respectively. Patients in group whose HbA1c level was monitored were seen and their insulin regimens changed more often, but they were hospitalized for acute care of their diabetes less often than those in control group. A similar decrease in HbA1c values occurred in control group in following year, when their caregivers knew their HbA1c values


Cohort of diabetics (n=120) evaluated by physicians without HbA1c measurement

Identity between classifications was seen in 52%, but 30% of diabetics were considered in good or acceptable control despite HbA1c values >10.0%

Lenzi, Giampietro, et al. 198777

Longitudinal cohort (n=234, for two years) in type 1 (n=139) and type 2 (n=95)

However, we found that one of every three well-controlled patients (both type I and II subjects) had high values for HbA1

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Fructosamine testing Three RCTs were identified. Two prospective cohort studies and five retrospective studies were also identified.78-80 Little of the available evidence suggested an advantage to using fructosamine testing. One RCT showed that glucose testing was better than fructosamine testing after six months. Several retrospective cohorts suggested that it was poorly predictive of glycemic control. One survey suggested physicians thought that fructosamine measurements were helpful (Table 5).

Table 5: Fructosamine testing


Chen, Chen, et al. 200281

Longitudinal time-series cohort (n=25) of type 2 diabetics

HbA1c measurement correlates more significantly with home capillary blood glucose levels than fructosamine assay, even over previous 2 to 3 weeks

Lindsey, Carter, et al. 200282

Interim results of RCT (n=60+) randomly assigned to collect weekly fructosamine in addition to daily glucose (group 1) or usual care of daily glucose (group 2)

No statistical difference at 3 months (p=0.676) in A1C values for group 1 (7.921%±1.848% versus 7.755%±1.408%) and group 2 (7.800%±1.505% versus 7.971%±1.797%) were noted when compared with baseline

Edelman, Bell, et al. 200183

RCT (n=25) Two groups: glucose-only testing group (14 patients with an initial mean HbA1c of 9.4±0.9%) and a combined glucose plus fructosamine testing group (11 patients with an initial mean HbA1c of 9.2±0.7%)

Study results after 3 months showed that HbA1c values in combined glucose plus fructosamine testing group decreased from 9.2±0.7% to 8.0±0.5% (p<0.0001). In contrast, HbA1c values in glucose-only testing group declined from 9.4%±0.9% to 9.1%±1.3%, a difference that was not significant.

Petitti, Contreras, et al. 200184

RCT (n=140) adults (HbA1c>8%) randomized to fructosamine or glucose monitoring

No significant difference was found between two groups in mean absolute decrease of HbA1c levels at 3 months (0.5% in fructosamine group versus 0.8% in control group; P>0.2), and difference favoured control group at 6 months (0.7% fructosamine versus 1.2% control; p=0.04).

Narbonne, Renacco, et al. 200185

Retrospective blood sample study of diabetics (n=76) and healthy (n=30) subjects

Risk of misclassification was around 10% when fructosamine was used to estimate HbA1c. These results were unchanged when fructosamine was corrected by plasma protein level.

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Austin, Wheaton, et al. 199986

Retrospective cohort comparing fructosamine plus standard tests versus standard tests and survey of physicians

Availability of same-day fructosamine results did not improve diabetes control compared with that obtained using only fasting serum glucose values and prior HbA1c concentrations. Most examining physicians stated that same-day fructosamine concentrations helped them significantly with diabetes management

Cefalu, Wang, et al. 199987

Cross-sectional (n-=51) and prospective cohort (n=20, type 2 diabetes) studies

Fingerstick fructosamine was shown to correlate highly to laboratory fructosamine (r=0.80, p<0.001) and glycated hemoglobin (r=0.81, p<0.001).

Kruseman, Mercelina, et al. 199288

Retrospective blood sample study (n=98)

Despite significant correlation, predictive values of parameters studied for acceptable HbA1c value seemed to be low (37% and 44% respectively)

Gebhart, Wheaton, et al. 199189

Retrospective cohort (n=17) study Of three types of glycated protein assays, fructosamine, with its advantage of speed and simplicity, may offer a more cost-effective alternative

Lim, Jhoo, et al. 198990

Retrospective blood sample study comparing normal (n=50) and NIDDM (n=36) patients

Fructosamine concentration had significant correlation to fasting plasma glucose determined 2 weeks before (r=0.72, p<0.002)

Mercelina, Degenaar, et al. 198969

Duplicate of Kruseman et al. study

Despite significant correlation, predictive values of parameters studied for acceptable HbA1c value seemed to be low (37% and 44% respectively)

POC=point of care Research question 2 b) If there is evidence that testing leads to improved glycemic control, what is the optimal frequency? Response to question 2 b) In type 1 diabetes, where there is evidence to support the assertion that testing leads to glycemic control, two reports (one RCT40 and one interrupted time-series23) were identified. Neither report concludes testing frequency (below two strips a day) has a discernible impact on glycemic control (Table 6).

Table 5 cont’d…

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Table 6: Studies of optimal frequency for SMBG Citation Design Highlighted Conclusions

Gordon, Semple, et al. 199140

RCT with crossover (n=25): trial arms were four-point profiles on 2 days per week; four-point profiles on 1 day per week; two-point profiles on every day of week

No correlation between frequency at which patients altered insulin doses and measures of metabolic control. Altering frequency of SMBG had variable and uncertain influence on frequency at which patients altered insulin doses



No discernible effect of policy change among insulin-treated patients

Research question 2 c) What is the evidence that testing results are used to modify lifestyle and medication therapy for persons with diabetes? Response to question 2 c) No trial was identified that examined the influence of testing on modifying behaviour. An abundance of research exists (including one systematic review) to describe the influence of educational strategies on modifying behaviour. Research question 3) What is the evidence that improving glycemic control leads to reduced or delayed complications in individuals diagnosed with type 1 or type 2 diabetes? Response to question 3) Type 1 diabetes: Evidence from two randomized controlled trials (RCTs)91,92 including one involving >1,400 patients followed for 6.5 years shows that the development and progression of retinopathy, nephropathy and neuropathy can be delayed by more intensive therapy tailored to target HbA1c and blood glucose goals. Further supportive evidence was available from three longitudinal cohort studies and a cross-sectional survey (Table 7).

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Table 7: Studies of the effect of glycemic control on reductions in mortality and morbidity in type 1 diabetes

Author(s), Year Design Results

Kawano, Omori, et al. 200193

Cross-sectional survey (n=6,472)

Prevalence of diabetic neuropathy as determined by attending physician increased with disease duration and worse control of diabetes. Study found that most diabetics suffered from neurological symptoms, although half of such symptoms were not considered to be those of diabetic neuropathy by physicians

Kullberg & Arnqvist 199594

Longitudinal cohort of adults diagnosed before 31 and with a duration of diabetes of >20 years, follow-up 9.4 years

Patients without retinopathy had a mean HbA1c±SEM for the whole follow-up period of 6.3±0.19%; the 117 patients with background retinopathy but not macula edema, 7.0±0.08

Kullberg, Finnstrom, et al. 199495

Longitudinal cohort of adults diagnosed before 31 and with a duration of diabetes of <25 years, follow-up 9.2 years

Patients with mean HbA1c>8% had higher relative risks for background retinopathy, compared with patients having HbA1c≤7%

The Diabetes Control and Complications Trial (DCCT) Research Group 199391

MC unblinded RCT type 1 diabetics with no retinopathy (n=726) or mild retinopathy (n=715) randomized to intensive or conservative therapy for 6.5 years

76% RRR (62% to 85%) in retinopathy; 26% RRR (8% to 50%) in macular edema; 60% RRR (38% to 74%) in neuropathy

Brinchmann-Hansen, Dahl-Jorgensen, et al. 199239

Longitudinal cohort study with follow-up for seven years

Mean value for HbA1>10% was associated with increased risk of progression of retinopathy; mean value <8.7% was associated with diminished risk

Reichard, Britz, et al. 199092

RCT (n=97) for five years comparing intensified treatment to regular treatment

HbA1c (normal range 3.9% to 5.7%) was reduced from 9.5±0.2 (mean value±SEM) to 7.4±0.1% in the ICT group (P=0.0001) and from 9.5±0.2 to 9.0±0.2% in RT group (P=0.004). Lower HbA1c levels during study significantly reduced risk of deterioration (P=0.01). Improved blood glucose control slowed progression of microangiopathy during 3-year period in patients with non-proliferative retinopathy, but at price of increased frequency of serious hypoglycemic episodes and gain in body weight

MC=multi-centre; SEM=standard error of the mean; RRR=relative risk reduction; ICT=intensified treatment; RT=regular treatment

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P R E -A S S E S S M E N T Type 2 diabetes: Fourteen reports describing six RCTs, and observational studies of retrospective (n=4) and prospective (n=2) designs were found (Table 8). One RCT96 was designed to examine the effect of glycemic control on all-cause mortality and morbidity in newly diagnosed type 2 diabetics. No effect on mortality from intensive glycemic control (<6 mmol/L) after 10 years was detectable. The results also suggest approximately 20 (95% CI 10 to 500) patients would have to apply strict control for 10 years to avoid one complication. Most of these complications were retinopathic. Heart disease was unaffected by tight glycemic control. Individuals with tighter glycemic control did not necessarily do better than those on less strict control suggesting that other factors (such as the drug used) may be more important than simply maintaining glycemic control. Results from the four other RCTS suggest retinopathy and nephropathy may be minimized, however, the reported effect of glycemic control on heart disease has been inconsistent.97

Table 8: Studies of the effect of glycemic control on mortality and

morbidity in type 2 diabetes

Report Design Results

Wanjohi, Otieno, et al. 200298

Cross-sectional cohort study Only 48% had HbA1c<8% while 36% had HbA1c>9%; it was established that 26% had albuminuria

Rush, O'Connor, et al. 200199

Retrospective time series using HMO database

HbA1c decreased from 8.56% to 7.33% (1994 to 2000). Average Charlson score during same period 1.48 to 1.76 (comorbidity increased)

Wagner, Sandhu, et al. 2001100

Retrospective cohort study Those with 1% HbA1c improvement in 1 year maintained for additional year were associated with cost savings

Levin, Coburn, et al. 2000101

MC RCT of 153 men with type 2 diabetes (1 insulin injection every morning) comparing intensive treatment stepped plan from 1 evening injection of insulin, alone or with glipizide, to multiple daily injections designed to attain near-normal glycemia levels (same as Abraira study)

Intensive glycemic control retards microalbuminuria in patients who have had type 2 diabetes for several years but may not lessen the progressive deterioration of glomerular function

Azad, Emanuele, et al. 199997

Same as Levin study Our conclusion was that 2 years of meticulous glycemic control did not decrease overall prevalence of peripheral or autonomic neuropathy. Prevalence rose equivalently and significantly in both treatment arms

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Guillausseau, Massin, et al. 1998102

Longitudinal cohort study (n=64) for 7 years

Relative risk for developing retinopathy (RR) was 7.2 (CI 95%: 1.61 to 32.4) in patients with mean HbA1 during follow-up above median value of cohort (8.3%) compared with patients with HbA1 during follow-up below this value

UK Prospective Diabetes Study (UKPDS) Group 199896

MC unblinded RCT (n=4,209). Type 2 diabetics stratified into overweight versus normal weight. Overweight randomized to strict control with insulin, strict control with sulfonylurea, less strict control. Normal weight randomized to strict-insulin, strict-sulfonylurea, strict-metformin and less strict. Mean follow-up 10 years

Tight control (<6 mmol/L) did not prevent mortality. NNT to avoid one complication 19.6 (95% CI 10 to 500) patients have to apply strict control for 10 years. Macrovascular complications unaffected by tight control

Abraira, Colwell, et al. 1997103

Same as Levin study Mild and moderate hypoglycemic events were more frequent in intensive than in standard treatment arm (16.5 versus 1.5 per patient per year respectively). Mean insulin dose was 23% lower in standard treatment arm (p<0.001). There were 61 new cardiovascular events in 24 patients (32%) in intensive treatment arm and in 16 patients (20%) in standard treatment arm (p=0.10).

Malmberg 199778 RCT secondary prevention of diabetic patients (n=620), (majority type 2 diabetes) who had suffered an MI randomized to acute insulin-glucose infusion followed by long-term intensive insulin

Those who had intensive insulin treatment had absolute reduction of mortality of 11% (44% versus 33%) compared with regular therapy group after 3.4 years of follow-up

Rindone, Austin, et al. 1997104

Retrospective cohort Glucose control was independent of number of strips dispensed. Home glucose monitoring strips did not affect the management of patients with NIDDM taking a sulfonylurea agent in primary care setting

Ohkubo, Kishikawa, et al. 199579

RCT of type 2 diabetes (n=110) Those who received multiple insulin injections had 24% absolute reduction in progression of retinopathy and 20% reduction in progression of nephropathy after 6 years of follow-up, when compared with conventional therapy group

Table 8 cont’d…

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Gallichan 1994105 Survey plus RCT: SMBG versus urine testing

Trial showed no significant difference in the diabetes control of blood testers and urine testers over six months

Morisaki, Watanabe, et al. 1994106

Cohort (n=114) for 5 years Incidence of progression of retinopathy increased linearly as function of HbA1c level: 2% in those with HbA1C<0.070 and 62% in those with HbA1C>0.090

Goldner, Knatterud, et al. 197180

RCT comparing insulin, tolbutamide and phenformin (n=1,027) versus placebo

No treatment prevented microangiopathic or cardiovascular complications of diabetes, but trial was stopped prematurely due to rise in phenformin mortality and tolbutamide cardiovascular mortality

MC=multi-centre; CI=confidence interval; MI=myocardial infarction

Conclusions The biggest cost of implementing intensive control of blood glucose concentrations in type 2 diabetes relates to the use of home blood glucose monitoring.107 Most diabetics in Canada are type 2, yet it is in this population that evidence seems to be most lacking. In particular, factors other than glycemic control may play an important role in influencing overall morbidity. Whether self-monitoring in this population will lead to better glycemic control or established clinical benefit is unclear. The answers to these questions will lead to large resource implications.

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