protocol title: type 2 diabetes mellitus - ccc-ids.org · 2 3 protocol development & review...

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Protocol Title: Type 2 Diabetes Mellitus

Effective Date: Version: 1.0 (Revised: 6/11/2014)

Approval By: Planned Review Date:

1 Purpose & Objective This protocol provides evidence-based care recommendations in the screening and treatment of patients

with Type 2 Diabetes Mellitus in the primary care setting.

2 Scope of Protocol

2.1 Target Population

This protocol was derived from clinical guidelines for individuals in the CCC population diagnosed with Type

2 Diabetes Mellitus, 18 years of age or older.

2.2 Target Users

This protocol is developed for use in primary care settings.

2.3 Excluded Topics This protocol does not address the clinical management of patients with Pre-Diabetes, Type I Diabetes,

Gestational Diabetes, or Pediatric patients.

2.4 Related Guidelines

Standards of Medical Care in Diabetes-2014. Diabetes Care, January 2014, Vol. 37: Supplement 1, S14-S80;

doi:10.2337/dc14-S014

National Standards for Diabetes Self-Management Education and Support. Diabetes Care, January 2014, Vol.

37: Supplement 1, S144-S153; doi:10.2337/dc14-S144

AACE Comprehensive Diabetes Management Algorithm 2013. Endocrine Practice, 19, 327-335.

Joslin Diabetes Center and Joslin Clinic Guideline for Specialty Consultation/Referral, July 2013.

Diabetes Minimum Practice Recommendations for Children and Adults, Texas Diabetes Council/DSHS,

August 2012.

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3 Protocol Development & Review Process

Protocol Development & Review Process

This protocol originated in the CCC Clinical Protocol Subcommittee, led by an Endocrinologist specializing in

Diabetes. A group of clinical staff met and converged on the items in this document via a Rapid Design

Session. In this session, a facilitator guided the group through the process to extract evidence-based

elements to adequately care for the CCC population impacted by Type 2 Diabetes. The above depiction

describes the approval and subsequent review process for this protocol.

Group Name Approval Date

CCC Diabetes Protocol Subcommittee 4/18/2014

CCC Clinical Protocols Workgroup 4/23/2014

CCC Clinical Delivery System Steering Group 03/2016; 08/2016

CCC Advisory Committee 5/27/2014

CCC Board of Directors 5/13/2014

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4 Screening Criteria & Risk Factors

4.1 Assessing Risk

1. Body Mass Index of ≥25kg/m2 (≥ 23 kg/m2 in Asian Americans) and at least one of the following additional

risk factors:

Physical inactivity

First degree relative with diabetes

High risk race/ethnicity (e.g. African American, Latino, Native American, Asian American, Pacific

Islander)

Women delivering a baby weighing greater than 9 lbs or were diagnosed with Gestational Diabetes

Mellitus (GDM)

Hypertension (>140/90 mmHg or on therapy for hypertension)

HDL <35 mg/dl +/- TG > 250 mg/dl (previously was LDL >100 mg/dl)

Women with polycystic ovarian syndrome

A1C ≥5.7%, Impaired Glucose Tolerance (IGT), or Impaired Fasting Glucose (IFG) on previous testing

Other clinical condition associated with insulin resistance (severe obesity, acanthosis nigricans)

History of Cardiovascular Disease (CVD)

2. In the absence of meeting criteria associated with item #1, general testing should:

Begin at 45 years of age and end at approximately 75 years of age.

(During this period, if life is limited due to other major illness; DO NOT SCREEN)

o If results are normal, testing should be repeated at least at 3-year intervals, with

consideration of more frequent testing depending on initial results

o Refer to Pre-DM protocol

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5 Screening Tests

1. Hemoglobin A1C (A1C)

This test should be performed in a laboratory using a method that is NGSP certified and

standardized to the DCCT assay.

If abnormal Point of Care result, confirm with laboratory assay.

2. Fasting Plasma Glucose (FPG)

If abnormal test result, confirm X1 (on a different day); fasting is defined as no caloric intake for

at least 8 hours.

3. 2 hour Oral Glucose Tolerance Test (OGTT)

The test should be performed as described by the World Health Organization(WHO), using a

glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.

4. Random Plasma Glucose (RPG)

Not a finger stick

≥200mg/dL

In patients with symptoms of hyperglycemia or hyperglycemic crisis

Other considerations

Routine measurement of insulin levels is not recommended

In the absence of unequivocal hyperglycemia, result should be confirmed by repeat testing on a

separate day.

6 Criteria for Diagnosis of Type 2 Diabetes

A1C ≥6.5% or;

FPG ≥126 mg/dL or;

Two-hour Plasma Glucose (PG) ≥200 mg/dL during an OGTT or;

In patients with classic symptoms of hyperglycemia, a random plasma glucose ≥200 mg/dL

Repeat tests to rule out laboratory error

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7 Assessment of Glycemic Control in Diabetes

7.1 Patient Self-Monitoring of Blood Glucose (SMBG)

SMBG frequency and timing should be dictated by patient's specific needs and goals

Ongoing need for and frequency of SMBG should reevaluated at each routine visit

Recommended testing times for Multiple-dose Insulin Therapy: o Prior to meals and snacks o Bedtime

And consider the following:

o Occasionally post-prandially o Prior to exercise o Suspect low blood glucose o After treating low blood glucose until normoglycemic o Prior to critical tasks (e.g., driving)

Ensure patients receive ongoing instruction and regular evaluation of SMBG technique and SMBG results

7.2 A1C

Every 6 months (At least two times a year): o Patients who are meeting treatment goals and have good glycemic control:

Every 3 months (Quarterly): o Patients whose therapy has changed or who are not meeting glycemic goals

Point of Care (POC) testing for A1C provides opportunity for more timely treatment changes

Consider fructosamine testing for patients in whom A1C may not be reliable/appropriate: o Patients with diseases that reduce red blood cell lifespan, such as hemolytic anemia or

hemoglobinopathies such as sickle-cell disease o Any condition that changes serum albumin (such as the nephrotic syndrome)

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8 Glycemic Recommendations for Non-Pregnant Adults with Type 2 Diabetes

A1C o <7%* for most patients

Preprandial Capillary Plasma Glucose o 70-130 mg/dL*

Peak Postprandial Capillary Plasma Glucose o <180 mg/dL* o 2 hours after the beginning of the meal o Post-prandial glucose may be targeted if A1C goals are not met despite reaching preprandial

glucose goals *Goals should be individualized based on:

Individualized goal must be documented

Duration of diabetes

Advanced age

Life expectancy < 5 years

Known CVD or advanced microvascular complications

Hypoglycemia unawareness

Individual patient considerations

More or less stringent glycemic goals may be appropriate for individual patients: More stringent HgA1c 6.5%:

Short diabetes duration

Long life expectancy No significant CVD/vascular complications

Less stringent HgA1c: criteria above

HEDIS Guideline: A1C < 8%

All women of childbearing age with diabetes should be educated about the importance of strict glycemic control prior to conception and should participate in effective family planning. Women with poorly controlled diabetes and pregnancy are at much higher risk for fetal complications.

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9 Medication Treatment (Refer to Diabetes Medications Spreadsheet Attachment)

9.1 Oral Treatment Algorithm

Consider treatment for patients with A1C 6.5 – 6.9%

*Metformin is contraindicated in renal insufficiency (women Cr 1.4, Men Cr 1.5), ESLD, CHF or other

conditions resulting in increased risk of lactic acidosis.

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Other Considerations -

For patients with a recent diagnosis (< 1 year) of Type 2 Diabetes Mellitus and on insulin therapy

with a total daily dose (TDD) < 30 units, consider transition to oral/non-insulin medication

treatment.

For patients with longstanding diagnosis (≥ 10 years) of Type 2 Diabetes Mellitus, consider

immediate initiation of insulin therapy

For patients who cannot administer multiple daily injections (MDI) of insulin, consider premixed

insulin.

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9.2 Profiles of Anti-Diabetic Medications

Reprinted with permission from American Association of Clinical Endocrinologists. Garber AJ, Abrahamson, MJ, Barzilay JI, et al. AACE

Comprehensive Diabetes Management Algorithm. Endocr Pract. 2013;19:327-336.

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9.3 Basal Insulin Treatment Algorithm

For use with patients with A1C ≤ 10%

Refer to Basal-Bolus Insulin Treatment Algorithm (9.4) if A1C > 10%

Other considerations -

*Modify oral treatment -

o Individuals on Metformin should continue, recommend discontinuing TZD, consider tapering

off SU

For patients who cannot administer multiple daily injections (MDI) of insulin, consider premixed

insulin.

(See Next Page for Cont’d Algorithm)

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Basal Insulin Treatment Algorithm Cont’d

(Adapted from 2009 ADA Diabetes Standards of Medical Care)

*Individualized A1C Goal

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Other considerations –

Patients who are not able to self-titrate should be referred to Diabetes Team for titration.

9.4 Basal-Bolus Insulin Treatment Algorithm

For use with patients with A1C > 10%

(Refer to 9.5 Alternate Insulin Algorithm for Patients with A1C > 10% using NPH and Regular Insulin or

Fixed 70/30 Mix Insulin)

**BASAL-BOLUS INSULIN CALCULATION GUIDE** 1. Calculate Total Daily Dose of Insulin on actual body weight:

0.5 units x actual body weight (kg) = Total Daily Dose of Insulin 2. Long-acting Insulin Dose = 50% of Total Daily Dose of Insulin given once daily 3. Rapid-acting Insulin Pre-Meal Dose = 50% of Total Daily Dose of Insulin divided by 3

to be given within 15 minutes before eating or right after eating (Breakfast, Lunch, and Dinner) *Educate patient that rapid-acting insulin should not be given if skipping a meal

4. Choose appropriate correctional scale below based on Total Daily Dose of Insulin

*** CORRECTIONAL Insulin ***

LOW DOSE CORRECTION

Patient requires less than 40 units insulin per day. Use this scale if

elderly (> 65 years), or on dialysis

MEDIUM DOSE CORRECTION

Patient requires 40 to 80 units insulin per day

HIGH DOSE CORRECTION

Patient requires greater than 80 units insulin per day or is on high dose

steroids (e.g. prednisone 20 mg per day or greater)

BG (mg/dL) BG (mg/dL) BG (mg/dL)

71-149 0 71-149 0 71-149 0

150-199 + 1 unit 150-199 + 2 units 150-199 + 3 units

200-249 + 2 units 200-249 + 4 units 200-249 + 5 units

250-299 + 3 units 250-299 + 6 units 250-299 +7 units



Greater than 399 mg/dL

+ 6 units & call MD


+ 12 units & call MD


+ 15 units & call MD

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9.5 Alternate Insulin Algorithm – NPH & Regular Insulin or Fixed 70/30 Mix Insulin

For use with patients with A1C > 10%

1. Calculate Total Daily Dose of Insulin on actual body weight:

0.5 units x actual body weight (kg) = Total Daily Dose of Insulin

2. Determine meal pattern of patient. For this regimen, patients must eat 3 meals daily, with

consistent carbohydrate intake at each meal.

3. Intermediate acting insulin should be 2/3 the total insulin dose and regular insulin should be 1/3 of

the total insulin dose (if using a 70/30 mix, this is already calculated for you).

4. Of the 2/3 NPH dose, 2/3 should be in the morning, and 1/3 should be given in the evening. Of the

regular insulin, 2/3 should be given in the morning half hour before breakfast and 1/3 should be

given in the evening half an hour before dinner.

5. Give 2/3 of the total insulin in the morning, 30 minutes before breakfast, and 1/3 in the evening, 30

minutes before supper.

Other considerations –

For patients who eat their heaviest meal in the evening, ½ of the total insulin dose might

need to be taken before supper time.

Patients on NPH usually need a light snack at bedtime (consisting of 10 to 15 grams of CHO

and some protein).

When switching from basal-bolus to NPH/Regular regimen, use the previous total daily

insulin dose. (NPH/regular regimen generally 20% more TDD, than basal bolus.)

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10 Management and Referrals

10.1 Diabetes Minimum Practice Recommendations

(Adapted from Texas Diabetes Council and Texas Department of State Health Services – Diabetes Minimum

Practice Recommendations – Revised 8/9/12)

Complete History & Physical Initial visit and at clinician’s discretion (including risk factors, exercise & diet)

Family History Annually

Education & Counseling

Diabetes Education1 Initial visit, annually, and at clinician’s discretion

Medical Nutrition Therapy Initial visit, annually, and at clinician’s discretion

Exercise Counseling Initial visit and at clinician’s discretion

Preconception counseling and family planning for women of reproductive age

Initial Visit and at clinician’s discretion

Depression Screening2 Initial visit and at clinician’s discretion

Sexual Function (male/female) Initial visit and at clinician’s discretion

Lifestyle/Behavior

Smoking Cessation Initial visit and at clinician’s discretion

Alcohol Reduction Initial visit and at clinician’s discretion

Physical Examination

Blood Pressure Target: <140/90 mm Hg Target: <125/75 mm Hg if ≥1g proteinuria

Every visit

Weight/Height Every visit (Height annually)

BMI Adult Overweight = BMI 25-29.9 Adult Obesity = BMI ≥ 30

Every visit

Foot Exam • Visual inspection for skin and nail

lesions, calluses, infections, deformities • Monofilament & 128 Hz tuning fork • Pedal Pulses

Every visit Annually or as needed Annually or as needed

Oral/Dental Inspection Refer for dental care every 6 months

Every visit

Dilated Fundoscopic Eye Exam (ophthalmology or optometry)

Annually or as indicated by eye specialist

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Laboratory Studies

A1c3 Every 3-6 months

Kidney • BUN/Creatinine • eGFR • Urine MicroAlb:Cr ratio4 • iPTH5

Annually or every 3-6 months if abnormal Annually or every 3-6 months if abnormal Initial visit, then annually (See Footnote) As indicated (if CKD stage 3+)

Liver • AST (SGOT) / ALT (SGPT)

Annually or every 3-6 months if abnormal

Lipid Profile • Triglycerides • HDL • LDL

Annually if at goal; otherwise every 3-6 months

TSH Annually or as needed

Immunizations6

Influenza vaccine Annually

Pneumococcal vaccine Age <65; Repeat ≥ 65 (at least 5 yrs apart)

Tdap Every 10 yrs

Shingles vaccine One time at age 60

Hepatitis A 2 doses

Hepatitis B 3 doses

1Diabetes Education should address self-care behaviors including healthy eating, being active, monitoring, taking

medication, problem solving, reducing risks, and healthy coping (From the American Association of Diabetes Educators

7 Self-Care Behaviors TM framework found at http://www.diabeteseducator.org/ProfessionalResources/AADE7/

2 Patient Health Questionaire-2 (PHQ2, depression screen) and Patient Health Questionaire-9 (PHQ9, depression

diagnosis)

3 Intensify management if: Absent/stable cardiovascular disease, mild-moderate microvascular complications, intact

hypoglycemia awareness, infrequent hypoglycemic episodes, recently diagnosed diabetes. Less intensive management if: Evidence of advanced or poorly controlled cardiovascular and/or microvascular complications, hypoglycemia unawareness, vulnerable patient (i.e. impaired cognition, dementia, or a history of falls). 4 Because of variability in urinary albumin excretion, two of three specimens collected within a 3- to 6- month period

should be abnormal before considering a patient to have developed increased urinary albumin excretion or had a progression in albuminuria. Exercise within 24 h, infection, fever, CHF, marked hyperglycemia, and marked hypertension may elevate urinary albumin excretion over baseline values. (American Diabetes Association 2014 Practice Guidelines) 5 Consider Nephrology or Endocrinology evaluation if CKD stage 3, proteinuria, elevated iPTH

6Refer to CDC guidelines at http://www.cdc.gov/vaccines/schedules/easy-to-read/index.html for updates

http://www.diabeteseducator.org/ProfessionalResources/AADE7/

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10.2 Comprehensive Diabetes Evaluation

Medical History

• Age and characteristics of onset of diabetes (e.g., DKA, asymptomatic laboratory finding) • Eating patterns, physical activity habits, nutritional status, and weight history • Diabetes education history • Review of previous treatment regimens and response to therapy (A1C records) • Current treatment of diabetes, including medications, medication adherence and barriers thereto,

meal plan, physical activity patterns, and readiness for behavior change • Results of glucose monitoring and patient's use of data • DKA frequency, severity, and cause • Hypoglycemic episodes

• Hypoglycemic awareness • Any severe hypoglycemia; frequency and cause

• History of diabetes-related complications • Microvascular: retinopathy, nephropathy (sensory, including history of foot lesions;

autonomic, including sexual dysfunction and gastroparesis) • Macrovascular: CHD, cerebrovascular disease, and PAD • Other: psychosocial problems (Depression Screening)*, dental disease*

• Preconception counseling for women of child bearing age

Physical Examination • Height, Weight, BMI • Blood pressure determination, including orthostatic measurements when indicated • Fundoscopic examination* • Skin examination (for acanthosis nigricans and insulin injection sites) • Comprehensive foot examination

• Visual inspection for skin and nail lesions, calluses, infections, deformities

• Monofilament & 128 Hz tuning fork

• Pedal Pulses

Laboratory Evaluation • A1C, if results not available within past 2-3 months • If not performed/available within past year

• Fasting lipid profile , including total, LDL, and HDL cholesterol and triglycerides • Liver function tests • Test for urine albumin excretion with spot urine albumin-to-creatinine ratio • Serum creatinine and calculated GFR • TSH in dyslipidemia and women over age 50 years

Referrals • Eye care professional for annual dilated eye exam • Registered dietitian for MNT • DSME (at diagnosis and as needed thereafter) • Dentist for comprehensive periodontal examination • Behavioral Health Professional, if needed *See appropriate referrals for these categories

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10.3 Diabetes Referrals

(Adapted from Joslin Diabetes Center and Joslin Clinic: Guideline for Specialty Consultation/Referral

07/29/13)

All patients with Type 2 Diabetes require assessment by appropriately trained educators for evaluation of

education requirements, diabetes self-management education (DSME), glucose management training,

medical nutrition therapy (MNT), identification and prevention of complications, and activity/exercise

guidance.

Newly Diagnosed – Type 2 Diabetes

When

Diabetes Educator o Initial assessment and DSME, including

blood glucose monitoring, nutrition and physical activity

Registered Dietitian o Medical Nutrition Therapy (MNT)

Eye Care Specialist o Comprehensive dilated eye exam or

validated retinal imaging to evaluate for presence of retinopathy

Dentist o Comprehensive periodontal

examination

Behavioral Health Professional o In select patients for assessment

(coping strategies, support)

Family Planning o Women of reproductive age

Diabetes Specialist / Endocrinologist o Initiate management plan for acute

hyperglycemia in selected patients o Initiate plan for intensive control

At time of diagnosis and as needed thereafter






As needed

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10.4 Glycemic Control Based Referrals

A1C 7.0 – 7.9%

A1C ≥ 8.0%

Consider the following:

Diabetes Educator o General re-evaluation, as well as

DSME, physical activity guidance and ongoing consultation


Diabetes Specialist / Endocrinologist o If individualized patient goals not met

through intensive treatment in office after 6 months

Diabetes Educator o Evaluation, glucose management

training, and ongoing consultation


Diabetes Specialist / Endocrinologist o If individualized patient goals not met

through intensive treatment in office after 6 months

Behavioral Health Professional o Psychosocial assessment (non-

adherence, motivation)

Severe or Recurrent Hypoglycemia

Initiation of Insulin Pump Therapy or Physiologic Insulin Regimen

Diabetes Educator o Training in hypoglycemic treatment

and prevention, use of glucagon, evaluation and education on patient safety issues, and blood glucose awareness training, if available.

Diabetes Specialist / Endocrinologist o If recurrent episodes of severe

hypoglycemia Consider the following:

Behavioral Health Professional

Diabetes Educator o Training in pump use.

Registered Dietitian o Training in carbohydrate counting

Diabetes Specialist / Endocrinologist

Eye Care Specialist o Comprehensive dilated eye exam or

validated retinal imaging to evaluate for presence of retinopathy

Continuous Glucose Monitoring

Diabetes Educator o Training in continuous glucose monitor

(CGM) use.

Registered Dietitian o Training in carbohydrate counting

Diabetes Specialist / Endocrinologist

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10.5 Psychosocial Referrals

Psychosocial for Newly Diagnosed Diabetes

Need to Develop Skills for Coping with Diabetes

-Specific behavior/psychological problems associated with newly diagnosed diabetes -Depression/anxiety/general stressor -Adherence concerns -Diabetes burnout -Complications

Diabetes Educator o Diabetes Self-Management Education

(DSME) Consider the following for selected patients:

Behavioral Health Professional o Assessment of coping strategies,

support, etc.

Diabetes Educator o Diabetes Self-Management Education

(DSME)

Behavioral Health Professional o Such as a social worker,

psychologist/psychiatrist, psychiatric nurse practitioner

Eating Disorders

-Binge-eating disorder -Intentional insulin omission or reduction for purposes

of caloric purging -Unexplained DKA or repeatedly elevated A1Cs in which

psychological cause is suspected

Hypoglycemia Unawareness or Prevention of Recurrent

Severe Hypoglycemia

Registered Dietitian o Appropriate Medical Nutrition Therapy

(MNT)

Behavioral Health Professional o With specific expertise in eating

disorders and in the context of a multidisciplinary team approach

Diabetes Specialist / Endocrinologist Consider the following for patients with recurrent hypoglycemia:

Diabetes Educator o Blood glucose awareness training

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10.6 Cardiovascular Referrals

Blood Pressure

Blood pressure ≥ 140/80 mmHg on 3 occasions

Lipid Management

Diabetes Specialist / Endocrinologist o If secondary cause is suspected

Hypertension specialist or Nephrologist o For difficulties in blood pressure

management or inability to reach goals with conventional treatment over a 6-12 month period


Registered Dietitian o Review sodium intake, weight

management issues and lifestyle modification (i.e. DASH eating plan)

Consider stress reduction/relaxation training

LDL Cholesterol ≥ 100 mg/dL with or without cardiovascular disease

o Registered dietitian for MNT and physical activity program

o Endocrinologist/Lipid Specialist if LDL goal not met within 12 months

Triglycerides ≥ 200 mg/dL (fasting sample) and non-HDL cholesterol > 130 mg/dL


o Endocrinologist/Lipid Specialist after aggressive lifestyle and medical intervention

Chylomicronemia (TG ≥ 1000 mg/dL) o Registered dietitian for MNT and

physical activity program o Endocrinologist/Lipid Specialist

Combined dyslipidemia (LDL-C ≥ 100 mg/dL, and TG ≥ 200 mg/dL, or HDL-C < 40 mg/dL)


o Endocrinologist/Lipid Specialist after aggressive lifestyle and medical intervention

o

Intolerance to statins or insufficient therapeutic response


o Endocrinologist/Lipid Specialist

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Cardiovascular Referrals Cont’d

Cardiovascular Management – Known Present Conditions

Presence of: -Known CAD -Unstable angina -Chest pain suggestive of ischemia -CHF -PVD -ECG changes consistent with ischemia -Arrhythmias including: atrial fibrillation, atrial flutter, SVT, ventricular tachycardia, second and third degree heart blocks

Cardiovascular Management –

At Risk

At risk patients - Type 2 Diabetes and at least one of the following:

- Microalbuminuria -Overweight/Obesity: BMI >25 kg/m2

-Dyslipidemia: LDL-C ≥100 mg/dL, HDL-C <40 mg/dL, TG >200 mg/dL -Known macrovascular disease (PAD) -Family h/o CAD: under 55 y/o -Hypertension: >140/90 mmHg on 3 occasions -Smoker -Starting physical activity program

Cardiologist

o Consultation to establish optimal medical treatment

Smoking Cessation Program Consider the following:

Registered Dietitian o MNT especially if BMI, lipid and/or

blood pressure goals are not achieved.

Exercise Physiologist and/or Cardiac Rehab

Program

o On recommendations of Cardiologist

Smoking Cessation Program Consider the following:

Registered Dietitian o MNT especially if BMI, lipid and/or

blood pressure goals are not achieved.

Exercise Physiologist and/or Cardiac Rehab

Program

o On recommendations of Cardiologist

See Lipid Management, Blood Pressure, Neuropathy Management, Management of Sexual Dysfunction sections

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10.7 Risk Management & Diabetes Complications Referrals

Management of Feet

*At risk includes patients who smoke, have vascular insufficiency, neuropathy, retinopathy, nephropathy, history of ulcers/amputations, structural deformities, infections, skin/nail

abnormalities, anticoagulation therapy, or who cannot see/feel/or reach feet.

Renal Status

-Rapid rise in creatinine level (e.g., 0.8-1.4 mg/dL in 12 months) -GFR < 45 ml/min -Uncertain etiology of nephropathy -Problems with management of ACE inhibitors -Anemia due to renal disease -Difficulties in management of hyperkalemia -Difficulties in management of hyperphosphatemia -Persistent proteinuria (> 300 mg/24 hrs) -Albuminuria that progressively increases over a six month -period -Presence of unexplained hematuria

At-Risk* Patients with Acute Problems

o Diabetes Educator for foot care and Diabetes Self-Management Education (DSME)

o Podiatrist for routine care and evaluation

o Consider physical therapist consult for falls prevention and gait training

Current Ulceration or Non-Healing Ulcer, or Infection


o Podiatrist or vascular surgeon for evaluation and follow-up care

Limb-Threatening Ulcer or Infection o Diabetes Educator for foot care and

Diabetes Self-Management Education (DSME)

o Podiatrist or vascular surgeon for immediate evaluation and treatment

Claudication Symptoms Severe Enough to Cause Disability or Decreased Quality of Life


o Vascular management team (vascular surgeon, interventional radiologist, or cardiologist) for diagnostic evaluation and treatment, if indicated.

o Vascular surgeon for surgical bypass or related procedures, if indicated.

Diabetes Educator o Evaluation and Diabetes Self-

Management Education and management of diabetes and kidney disease

Registered Dietitian o Medical Nutrition Therapy (MNT) for

GFR < 60 ml/min

Nephrologist

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Risk Management & Diabetes Complications Referrals Cont’d

Eye Care Management

Neuropathy Management

All Patients o Annual referral for comprehensive

dilated eye exam or annual validated retinal imaging to determine level of retinopathy. Follow-up and management based on level of retinopathy as determined above, but not less than annually.

o Prior to intensifying blood glucose control or initiating intensive exercise (e.g., high impact sports, free weights, exercises involving Valsalva maneuver)

New loss of vision, blindness, eye pain, red eye/ocular inflammation, floaters, flashes of light, double vision

o Immediate evaluation with ophthalmologist specializing or trained in managing eye diseases in patients with diabetes

Women with known diabetes who are planning pregnancy or who are pregnant

o Comprehensive dilated eye exam: Prior to planned pregnancy, early in first trimester, with follow-up as determined by level of eye disease, six to eight weeks postpartum

Patients with established visual loss following appropriate evaluation

o Diabetes Self-Management Education (DSME) Program specializing in vision impaired and adaptive devices

o Vision rehabilitation specialist to maximize vision

Acute weakness with or without pain including suggestions of diabetic amyotrophy

o Immediate evaluation with neurologist o Consider physical therapist consult for

falls prevention and gait training

Rapidly progressing neuropathy o Evaluation with neurologist

Severe painful neuropathy non-responsive to first-line therapy

o Evaluation with neurologist

Severe autonomic neuropathy including: - Cardiovascular, including orthostatic hypotension - Gastrointestinal, including gastroparesis and other bowel motility disorders - Urogenital, including: bladder motility disturbance, erectile dysfunction - Sudomotor (gustatory hyperhidrosis)

o When gastroparesis affects glycemic control, refer to Diabetes Educator for Diabetes Self-Management Education (DSME)

o Registered Dietitian for Medical Nutrition Therapy (MNT)


o Evaluation with neurologist, gastroenterologist, or urologist

o Physical Medicine & Rehabilitation o Pain Management

Subacute/chronic weakness indicative of neuropathy

o Evaluation with neurologist o Consider physical therapist consult for

falls prevention and gait training

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Risk Management & Diabetes Complications Cont’d

Periodontal Disease Management

Management of Sexual

Dysfunction

At initial visit and annually o Discuss need for dental exams at least

every six months o Diabetes Educator for overview of

dental care

Gingivitis/Periodontitis o May need dental

evaluation/treatment every 3-4 months

Dentist o Regular follow-up at least every 6

months o Oral symptoms such as sore, swollen,

or bleeding gums, loose teeth, or persistent mouth ulcers

Prosthodontist o If edentulous, for restoration of

functional dentition

Presence of structural/functional abnormality o Diabetes Educator for Diabetes Self-

Management Education (DSME) o Urologist for structural/functional

abnormality

Presence of hormonal abnormality or no specific etiology identified

o Males – Erectile Dysfunction Specialist (Endocrinologist or Urologist), or physician who specializes in men’s sexual health, if specific diagnosis in question or failure of trial with oral medication or concern with using oral therapy with specific patient

o Females – OB/GYN or physician who specializes in women’s sexual health for dyspareunia, arousal issues

Psychological issues suspected o Behavioral Health Professional, ideally

with experience in sexual dysfunction

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10.8 Emergency Department Referrals When Patient is Physically Present at Clinic*

Hyperglycemia

+ one or more of the following

Hypoglycemia (BG < 70 mg/dL)

+ one or more of the following

Symptomatic

Ketonuria

Tachycardia (pulse > 120 bpm)

New onset – BG ≥ 500 mg/dL

Pregnancy – BG ≥ 200 mg/dL

*Alarm Signs & Symptoms o Altered Mental Status (AMS) o Chest Pain o New Onset Shortness of Breath (SOB)

without prior diagnosis o Not tolerating PO o Focal Neurologic Changes o Fever ≥ 100.5 ◦F o Vomiting o Abdominal Pain o Infection

Patient is on Sulfonylurea or Long-acting Insulin

*Alarm Signs & Symptoms o Altered Mental Status (AMS) o Chest Pain o New Onset Shortness of Breath (SOB)

without prior diagnosis o Not tolerating PO o Focal Neurologic Changes o Fever ≥ 100.5 ◦F o Vomiting o Abdominal Pain o Infection

*Each clinic should follow their own

hypoglycemic protocols

Acute Loss of Vision

Diabetic Foot

Any occurrence of acute loss of vision

Acute loss of pulses in feet

Cyanosis

Cellulitis

Wet gangrene

*Considerations for Mode of Transportation to Emergency Department –

Ability to maintain airway

No focal neurologic changes

No cardiac signs and symptoms

If patient goes by private car, patient should not drive.

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11 Treatment Considerations for the Hypertensive Diabetic

Blood Pressure goal of 140/90 mmHg (ADA recommends 140/80 mmHg)

Treat Hypertension with or without micro albuminuria with ACE/ARB (First line)

Consider a Thiazide Diuretic and Calcium Channel Blocker as alternative agents

*Reference Hypertension Protocol

12 Diabetes Education

The CCC adopted the ADA National standards for Diabetes Self-Management Education and Support (DSME).

STANDARD 1

Internal Structure

The provider(s) of DSME will document an organizational structure, mission statement, and goals. For those

providers working within a larger organization, that organization will recognize and support quality DSME as

an integral component of diabetes care.

STANDARD 2

External Input

The provider(s) of DSME will seek ongoing input from external stakeholders and experts in order to promote

program quality.

STANDARD 3

Access

The provider(s) of DSME will determine who to serve, how best to deliver diabetes education to that

population, and what resources can provide ongoing support for that population.

STANDARD 4

Program Coordination

A coordinator will be designated to oversee the DSME program. The coordinator will have oversight

responsibility for the planning, implementation, and evaluation of education services.

STANDARD 5

Instructional Staff

One or more instructors will provide DSME and, when applicable, DSMS. At least one of the instructors

responsible for designing and planning DSME and DSMS will be a registered nurse, registered dietitian, or

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pharmacist with training and experience pertinent to DSME, or another professional with certification in

diabetes care and education, such as a CDE or BCADM. Other health workers can contribute to DSME and

provide DSMS with appropriate training in diabetes and with supervision and support.

STANDARD 6

Curriculum

A written curriculum reflecting current evidence and practice guidelines, with criteria for evaluating

outcomes, will serve as the framework for the provision of DSME. The needs of the individual participant will

determine which parts of the curriculum will be provided to that individual.

STANDARD 7

Individualization

The diabetes self-management, education, and support needs of each participant will be assessed by one or

more instructors. The participant and instructor(s) will then together develop an individualized education

and support plan focused on behavior change.

STANDARD 8

Ongoing Support

The participant and instructor(s) will together develop a personalized follow-up plan for ongoing self-

management support. The participant’s outcomes and goals and the plan for ongoing self-management

support will be communicated to other members of the health care team.

STANDARD 9

Patient Progress

The provider(s) of DSME and DSMS will monitor whether participants are achieving their personal diabetes

self-management goals and other outcome(s) as a way to evaluate the effectiveness of the educational

intervention(s), using appropriate measurement techniques.

STANDARD 10

Quality Improvement

The provider(s) of DSME will measure the effectiveness of the education and support and look for ways to

improve any identified gaps in services or service quality using a systematic review of process and outcome

data.

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13 Protocol Development Team

Name Affiliation

Mark Hernandez MD *Chief Medical Officer

Community Care Collaborative (CCC) & Seton Healthcare Family

Mrinalini Kulkarni-Date MD

*Clinical Champion

Seton Healthcare Family

Tamarah Duperval-Brownlee MD Lone Star Circle of Care

Aida Garza PharmD CommUnityCare

Becky Goldsmith RN, CDE Seton Healthcare Family

Andy Hofmeister EMT-P Austin Travis Co. EMS

Alina Ramos MD CommUnityCare

Laura Miles RD, LD, CDE Central Health / Community Care Collaborative

Lola Okunade MD Lone Star Circle of Care

Cathy Tomlinson RN CommUnityCare

Susan Dubois MD CommUnityCare

Richard Peavey MD People’s Community Clinic

Veronica Buitron-Camacho, MSN, RN Community Care Collaborative

Curk McFall, MSN, RN Community Care Collaborative (CCC) & Seton Healthcare Family

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14 References

Standards of Medical Care in Diabetes-2014. Diabetes Care, January 2014, Vol. 37: Supplement 1, S14-S80;

doi:10.2337/dc14-S014

National Standards for Diabetes Self-Management Education and Support. Diabetes Care, January 2014, Vol.

37: Supplement 1, S144-S153; doi:10.2337/dc14-S144

AACE Comprehensive Diabetes Management Algorithm 2013. Endocrine Practice, 19, 327-335.

Joslin Diabetes Center and Joslin Clinic Guideline for Specialty Consultation/Referral, July 2013.

Diabetes Minimum Practice Recommendations for Children and Adults, Texas Diabetes Council/DSHS,

August 2012.

30

15 Glossary of Abbreviations

Abbreviation Term

A1C

Hemoglobin A1C

ACE

Angiotensin-Converting Enzyme

ADA

American Diabetes Association

AGI

Alpha-Glucosidase Inhibitors

ALT

Alanine Aminotransferase

AMS

Altered Mental Status

ARB

Angiotensin Receptor Blocker

AST

Aspartate Aminotransferase

BC-ADM

Board Certified-Advanced Diabetes Management

BCR-QR

Bromocriptine- Quick Release

BMI Body Mass Index

BUN

Blood Urea Nitrogen

CAD

Coronary Artery Disease

CCC

Community Care Collaborative

CDE

Certified Diabetes Educator

CGM

Continuous Glucose Monitoring

CHD

Coronary Heart Disease

CHF

Congestive Heart Failure

CHO

Carbohydrate

CKD

Chronic Kidney Disease

COLSVL

Colesevelam

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Cr

Creatinine

CVD Cardiovascular Disease

DASH

Dietary Approaches to Stop Hypertension

DKA

Diabetic Ketoacidosis

DPP-4i

Dipeptidyl Peptidase-4 Inhibitor

DSME

Diabetes Self-Management Education

DSMS

Diabetes Self-Management Support

ECG

Electrocardiogram

eGFR

Estimated Glomerular Filtration Rate

ESLD

End-Stage Liver Disease

FPG Fasting Plasma Glucose

GDM

Gestational Diabetes Mellitus

GFR

Glomerular Filtration Rate

GI Sx

Gastrointestinal Side Effects

GLN

Glinide

GLP-1

Glucagon-like Peptide-1

GLP-1 RA Glucagon-like Peptide-1 Receptor Agonists

GU

Genitourinary

HDL

High Density Lipoprotein

HDL-C

High Density Lipoprotein-Cholesterol

HEDIS Healthcare Effectiveness Data and Information Set

Hr

Hour

HYPO

Hypoglycemia

Hz Hertz

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IFG Impaired Fasting Glucose

IGT Impaired Glucose Tolerance

iPTH

Intact Parathyroid Hormone

kg

Kilogram

LDL Low Density Lipoprotein

LDL-C

Low Density Lipoprotein-Cholesterol

MD

Doctor of Medicine

MDI

Multiple Daily Injections

MET Metformin

MicroAlb

Microalbumin

MNT

Medical Nutrition Therapy

NPH

Neutral Protamine Hagedorn

OB-GYN

Obstetrician-Gynecologist

OGTT Oral Glucose Tolerance Test

PAD

Peripheral Artery Disease

PG Plasma Glucose

PO

By Mouth

POC Point of Care

PP Postprandial

PRAML

Pramlintide

PVD

Peripheral Vascular Disease

qHS At Every Bedtime

RPG Random Plasma Glucose

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SGLT-2

Sodium Glucose Cotransporter-2

SGOT

Serum Glutamic Oxaloacetic Transaminase

SGPT

Serum Glutamic Pyruvic Transaminase

SMBG Self-Monitoring of Blood Glucose

SOB

Shortness of Breath

SU

Sulfonylurea

SVT

Supraventricular Tachycardia

Tdap

Tetanus, Diphtheria & Acellular Pertussis Vaccine

TDD

Total Daily Dose

TG

Triglycerides

TSH

Thyroid Stimulating Hormone

Tx

Treatment

TZD

Thiazolidinedione

protocol title: type 2 diabetes mellitus - ccc-ids.org · 2 3 protocol development & review...

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