Standards and Guidelines: Myths and Truths The Diagnostic Standard - - PowerPoint PPT Presentation

Standards and Guidelines: Myths and Truths

The Diagnostic Standard for Diabetes Mellitus is Fixed and Immutable

ADA Criteria for Diagnosis of Diabetes

A1C ≥ 6.5% FPG ≥126 mg/dl 2‐hour PG ≥200 mg/dl during OGTT Classic symptoms and random PG ≥200

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1)

The ADA standard for A1C is the same as the AACE standard.

ADA Guidelines: A1C Target AACE Guidelines: A1C Target

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

< 7.0%

“…for selected individual patients, providers might reasonably suggest even lower A1C goals than the general goal of <7%, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Such patients might include those with short duration of diabetes, long life expectancy, and no significant CVD….Conversely, less stringent goals may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, or advanced complications.”

< 6.5%

“…if it can be achieved safely. In patients with a history of severe

hypoglycemia, limited life expectancy, advance micro‐ or macrovascular complications, extensive co‐morbid conditions, or long‐standing DM where the general goal has been difficult to obtain, a goal of 7‐8% may be considered.”

Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print] (Adapted with permission from: Ismail-Beigi F, et al. Ann Intern Med 2011;154:554)

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The ADA and AACE Guidelines for screening of risk factors are the same.

ADA Guidelines: Screening

• Screen for diabetes at age 45 and every 3 yrs

after, or adults of any age with BMI > 25 kg.M2 and one or more additional risk factors

• Screen all at risk individuals. Persons with

prediabetes should have at least annual measure of FPG or OGTT

AACE Guidelines: Screening

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

ADA Guidelines:

Additional Risk Factors for Screening (AACE too)

• Physically inactive
• First‐degree relative with diabetes
• Members of a high risk ethnic population
• Delivered baby > 9 lbs or GDM
• Hypertensive (BP> 140/90 mmHg)
• HDL cholesterol <35 mg/dL and/or

triglyceride levels >250 mg/dL

• Women with polycystic ovary syndrome
• A1c > 5.7% or IGT or IFG on previous testing
• Other conditions associated with diabetes (PCOS,

(severe obesity, acanthosis nigricans)

• History of vascular disease

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

Postprandial glucose control levels are the same in the AACE guidelines as they are in the IDF Postmeal Guidelines

ADA Guidelines

AACE Guidelines

< 180 mg/dL peak postprandial capillary plasma glucose < 140mg/dL 2-hr post meal

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocr Pract. 2007; 13(suppl 1).

IDF Guidelines

• Target PPG levels should seldom rise above 140mg/dL

– PPG levels should return to basal 3 hrs post meal – SMBG is currently the optimal method for assessing plasma glucose levels

• Two hour PPG should not exceed 140mg/dL as long as

hypoglycemia is avoided

International Diabetes Federation. Guidelines for Management of Postmeal Glucose. Available at www.idf.org.

The new ADA Guidelines provide additional new recommendations

• n laboratory evaluation.

ADA

Initial Evaluation for Labs & Referrals

• Laboratory evaluation

– A1c – Fasting lipid profile – Test for urine albumin excretion – Serum creatinine and calculated (GFR) – TSH in T1, dyslipidemia, or women >50 – Liver function tests (LFT) – Screen for Celiac Disease in Children with type 1 diabetes

• Referrals

– Annual dilated Eye Exam – Family planning for women of reproductive age – Registered Dietitian for MNT – Diabetes Self Management Education – Dental Examination – Mental Health Professional (if needed)

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1)

The AACE Guidelines are more detailed on SMBG testing than ADA guidelines

SMBG Guidelines For Patients on Insulin

SMBG should be performed by all patients using insulin (minimum of twice daily and ideally at least before any injection of insulin) More frequent SMBG after meals or in the middle of the night may be required for patients with frequent hypoglycemia, patients not at A1C target, or those with symptoms

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

AACE Guidelines ADA Guidelines

Patients using multiple insulin injections or insulin pump therapy should do SMBG at least prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving For patients using less-frequent insulin injections, SMBG may be useful as a guide to management.

SMBG Guidelines For Patients NOT on Insulin

Patients not requiring insulin therapy may benefit from SMBG, especially to provide feedback about effects of their lifestyle and pharmacologic therapy Testing must be personalized

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

AACE Guidelines ADA Guidelines

When prescribed as part of a broader educational context, SMBG results may be helpful to guide treatment decisions and/or patient self- management for patients using less frequent insulin injections or noninsulin therapies

AACE General Guidelines

• Instruct patients to obtain comprehensive pre‐prandial and

2‐hour postprandial glucose measurements to create a weekly profile periodically and before clinic visits to guide nutrition and physical activity, to detect postprandial hyperglycemia, and to prevent hypoglycemia

• Instruct patients to monitor glucose levels anytime there is

suspected (or risk of) low glucose level and/or before driving

• Instruct patients to monitor glucose levels more frequently

during illness

American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocrine Practice 2007; 13(suppl 1).

ADA General Guidelines

• For individuals who have premeal glucose values within

target but have A1C values above target, monitoring postprandial plasma glucose (PPG) 1‐2 hours after the start

• f the meal and treatment aimed at reducing PPG values

to <180 mg/dL may help lower A1C

• When prescribing SMBG, ensure that patients receive

initial instruction in, and routine follow‐up evaluation of, SMBG technique and their ability to use data to adjust therapy

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1)

Both AACE and ADA have treatment algorithms for type 2 diabetes in their guidelines

Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]

AACE and ADA have similar recommendations for blood pressure and lipid control

AACE and ADA Guidelines Hypertension

• AACE Target BP <130/80
• ADA Target BP <140/80
• First line therapy

ACE inhibitor or ARB, if necessary in combination with other drug classes, along with lifestyle modification

• Individualize treatment according

to specific comorbidities

(ACE inhibitors and ARBs are contraindicated in pregnancy)

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

New in 2013

AACE and ADA Guidelines Dyslipidemia

• LDL<100mg/dL (<70mg/dL if CVD)
• HDL>40mg/dL in men; >50mg/dL in women
• Triglycerides <150mg/dL
• Lifestyle modifications (dietary and physical activity)
• Statins are pharmacologic treatment of choice

– Combination therapy if goals not achieved with monotherapy – If triglycerides>400mg/dL, use fibrates, niacin or fish oil – Niacin may be useful when primary abnormality is low HDL – Drugs other than statins may not impact cardiovascular risk

• Use low dose aspirin prophylaxis routinely for secondary prevention
• f CVD. Use for primary prevention for those at high risk (10 year risk

> 10%). Not recommended if 10 year CVD risk < 5%. In between, use judgment.

American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes Care 2013; 36 (Suppl. 1) American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocr Pract. 2011; 17(suppl. 2)

The ADA and AACE Guidelines do not consider bariatric surgery to be a treatment option for diabetes at this time

“The beneficial effect of surgery on reversal of existing diabetes and prevention of its development has been confirmed in a number of studies.” 2

2American Association of Clinical Endocrinologists

Handelsman Y, Mechanick JI, Blonde L et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care

• Plan. Endocrine Practice 2011; 17(S2), 15

3 International Diabetes Federation: Bariatric Surgical and Procedural Interventions in the Treatment

• f Obese Patients with Type 2 Diabetes , 2011

“Bariatric surgery may be considered for adults with BMI > 35 kg/m2 and type 2 diabetes, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacologic therapy.” 1

1American Diabetes Association. Standards of Medical Care in Diabetes-2013. Diabetes

Care 2013; 36 (Suppl. 1)

“Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities.”3

Bariatric Surgery

In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results.

Philip R. Schauer, M.D., Sangeeta R. Kashyap, M.D., Kathy Wolski, M.P.H., Stacy A. Brethauer, M.D., John P. Kirwan, Ph.D., Claire E. Pothier, M.P.H., Susan Thomas, R.N., Beth Abood, R.N., Steven E. Nissen, M.D., and Deepak L. Bhatt, M.D., M.P.H. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. This article (10.1056/NEJMoa1200225) was published on March 26, 2012, at NEJM.org.

In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures.

Geltrude Mingrone, M.D., Simona Panunzi, Ph.D., Andrea De Gaetano, M.D., Ph.D., Caterina Guidone, M.D., Amerigo Iaconelli, M.D., Laura Leccesi, M.D., Giuseppe Nanni, M.D., Alfons Pomp, M.D., Marco Castagneto, M.D., Giovanni Ghirlanda, M.D., and Francesco Rubino, M.D. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. This article (10.1056/NEJMoa1200111) was published on March 26, 2012, at NEJM.org.

The correlation between A1C and mean plasma glucose is best defined in a table in the ADA standards

Correlation Between A1C and Mean Plasma Glucose Levels

4 5 6 7 8 9 10 11 12 13

A1C%

mean plasma glucose levels (mg/dL) 69 97 126 154 183 212 240 269 298 326

The ADAG Study Updated the Mean Glucose‐HbA1c Relationship

• 10 clinical centers

– Cameroon, Denmark, Italy, Netherlands, and US

• Recruitment

– 300 persons with type 1 diabetes – 300 persons with type 2 diabetes – 100 persons without diabetes

• Excluded those with conditions that may interfere with measurement of glucose
• Distributed by race/ethnicity and A1C percentage (4‐6.5%, 6.6‐8.5%, >8.5%)
• A1c measured centrally q month x 4 mo
• Plasma and ISF Glucose Monitored

– Continuous glucose monitoring (CGM) for 2 days every month for 4 months – 8 point SMBG daily profile during CGM days – 7 point SMBG for 3 days per week (minimum)

Nathan, DM. ADAGE Research Group. Presentation at American Diabetes Association 67th Scientific Sessions. Chicago, 2007. (used with permission)