Clinical Guidelines for the Treatment of Type 2 Diabetes in the Non-Pregnant Adult June 2009

This document contains the following:        

Criteria for Diagnosis Treatment Goals Recommended Frequency of Diabetes Care Components Glycemia Management for the Non-Pregnant Adult, Step 1 Glycemia Management for the Non-Pregnant Adult, Step 2 Glycemia Management for the Non-Pregnant Adult, Step 3 LDL Management for the Non-Pregnant Adult Hypertension Management for the Non-Pregnant Adult

Therapeutic lifestyle changes, self-management education and ongoing monitoring by the patient and provider are important components of diabetes care. Healthcare providers should also be familiar with prescribing information for the medications identified in these guidelines. In addition to the statements above, important information pertaining to specific guidelines can be found on each page.

Disclaimer: These guidelines were established after careful review of current evidence and sound clinical practice and are endorsed by the Partners Diabetes Council. The recommendations serve to assist clinicians in the treatment of diabetes and do not seek to supercede the judgment of healthcare providers. Modifications may be appropriate in a given setting; particular relevant influences may include a given individual’s abilities, co-morbidities, overall health and anticipated lifespan. The responsibility for individual patient care decisions rests solely with healthcare providers.

Diagnosing Diabetes or Pre-Diabetes in the Non-Pregnant Adult An international expert committee reviewed criteria for diagnosis of diabetes in nonpregnant individuals and presented its findings in June, 2009. Noting that A1c better reflects long-term glycemia and better correlates with the occurrence of diabetes-related complications than single or episodic blood glucose measurements in most settings, the report recommended A1c as the primary tool to establish the diagnosis of diabetes and measure diabetes risk. This report is currently under review by the ADA and other national and international diabetes organizations. We offer the generally accepted criteria as well as this new proposal as alternative options for diagnosis.

Traditional Criteria: Diagnostic Criteria for Diabetes   

Random glucose 200 mg/dl with polyuria, polydipsia or weight loss, or Fasting glucose 126 mg/dl in the absence of intervening illness or steroid use*, or Plasma glucose 200 mg/dl at 2 hours on an oral glucose tolerance test (OGTT†) performed with 75 gm glucose administered *Requires confirmation on a separate day † Routine performance of OGTT is not recommended

Diagnostic Criteria for Pre-Diabetes  

Fasting blood glucose of 100-125 mg/dl (Impaired Fasting Glucose – IFG), or Blood glucose of 140-199 mg/dl (Impaired Glucose Tolerance - IGT) at 2 hours on OGTT* performed with 75 gm oral glucose administered As noted above, routine or common performance of OGTT is not recommended

Alternative Criteria: The diagnosis of diabetes is established by the finding of an A1c ≥ 6.5%. Confirmation should be made with a repeat A1c measurement; confirmation is not 2

required when an individual is symptomatic and blood glucose is > 200. Because type 1 diabetes generally appears soon after the onset of hyperglycemia with marked blood glucose elevation, its diagnosis is commonly established without use of the A1c. Those with an A1c of 6 – 6.4% are considered to be at increased risk of developing diabetes.

Those who demonstrate pre-diabetes/increased diabetes risk based on modest hyperglycemia should undertake demonstrably effective preventive interventions including dietary modification with weight loss when appropriate as well as the performance of regular exercise. The additional use of metformin, particularly among individuals under age 60, those with an elevated BMI or with additional risk-related concerns (e.g. metabolic syndrome or vascular disease) should be considered. It is noted that individuals with an A1c below 6%/lesser glucose elevation may still be at risk for developing diabetes later in life and, depending on the presence of other diabetes related risk factors, may also benefit from preventive interventions.

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Major Goal in the Treatment of Diabetes in the Non-Pregnant Adult: Control the ABCs (A1c, Blood Pressure, Cholesterol) A. A1c 500 mg/dl despite initial efforts.

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Recommended Frequency of Diabetes Care Components Action

Frequency Every 6 months if controlled (A1c 40 years and those 30-40 years with (81 mg/day) additional risk factors for vascular disease Review medication At every diabetes care visit management and lifestyle modification measures Psychosocial assessment: As needed. Depression may be present in upwards of 20% Emphasis on assessment of of the diabetes population. unsuspected depression Assess self-management At least annually; more frequently when appropriate skills: testing and insulin management; lifestyle habits; and overall diabetes knowledge A1c

* Some clinicians measure the urine microalbumin / creat on an annual basis (even after elevation is demonstrated) to titrate ACE/ARB dosing.

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Partners Diabetes Care Guidelines FAQs

What is the right HbA1c target for my patient(s)? The correct glycemic target for any patient with diabetes should be based on two ingredients: the demonstrated benefits of near normal glycemia on the long-term complications of diabetes and clinical judgment. The latter ingredient should inform the decision as to how low to go and is based on the balance of risks, effort, patient capabilities and anticipated benefit. While we now have a wealth of data on the magnitude of the benefit, and the risk of hypoglycemia, that can be expected at different levels of chronic glucose control, the decision "how tight is right" for any individual patient requires clinical judgment in concert with an open discussion with the patient regarding the rationale for his/her individual goal, since he or she will bear the burden of selfcare. Regarding the glycemic goals: several high quality clinical trials have shown a large decrease in microvascular complications affecting the eye, kidney and nerve in type 1 and type 2 diabetes. There is no question that the loss of vision, kidney failure, and amputations and other consequences of neuropathy can be substantially reduced with therapy that lowers chronic glycemia, as measured by the HbA1c, to near normal. Such therapy also lowers the risk of cardiovascular disease in type 1 diabetes and probably in type 2 diabetes. The level of HbA1c that is currently recommended is a HbA1c less than 7%. Recent studies have not shown a decrease in cardiovascular disease by trying to lower HbA1c levels even lower (to 6-6.5%) and one of these studies had a significantly higher mortality in the very intensive treatment group. So for now, the recommended level of HbA1c is 30 ml/min.

Alexander Turchin, MD, MS, Division of Endocrinology, Brigham and Women's Hospital

among the elderly? Older adults with diabetes have higher rates of coexisting illnesses such as hypertension and atherosclerosis than older adults without diabetes, so cardiovascular risk prevention strategies should be a primary focus of treatment. Clinical trials have shown that blood pressure and lipid control result in measurable benefits within 2 -3 years, while up to 8 years of intensive glycemic control are needed to see reductions in microvascular complications such as retinopathy, neuropathy, and renal disease. As well, the risks of intensive glycemic control may be greater in elderly patients. A higher prevalence of several common geriatric syndromes, as well as cardiovascular comorbidities, is seen among those with diabetes. These syndromes include polypharmacy, depression, cognitive impairment, urinary incontinence, injurious falls, and pain. Glycemic targets and BP/lipid goals need to be individualized depending on these factors. Quality of life should be weighed against the risks of complicated, costly, and potentially harmful medication and testing regimens. Individualized treatment goals for glycemic control, blood pressure and lipids, are appropriate for older adults. For frail individuals, hemoglobin A1c targets of 7-8% may be reasonable, with a focus on the short term benefits of moderate glycemic control, such as reduction of glycosuria/ polyuria, fatigue, and depression, and improvement in cognitive function and wound healing. For highly functional adults with a life expectancy of 5 years or longer, a hemoglobin A1c target of 7% or lower may be appropriate, although not supported by major clinical trial data demonstrating benefits of such a glycemic target in this age group. Medication risks are more likely in the elderly, including hypoglycemia, hypotension, and increased risk of hepatic or renal dysfunction. Thus, more frequent monitoring of renal function and potassium in those who are given ACE inhibitors, ARBs, or diuretics, and more frequent monitoring of hepatic function in those given niacin or a statin may be required. As well, safe use of metformin may require direct measurement of creatinine clearance with a timed urine collection in individuals over 80 years or those with reduced muscle mass. Avoidance of very long acting oral agents such as glyburide may also be appropriate.

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For a more detailed review of this topic, the reader is referred to the Guidelines for Improving the Care of the Older Person with Diabetes Mellitus, available through the American Geriatric Society at http://www.americangeriatrics.org/products/positionpapers/JAGSfinal05.pdf.

Melanie Brunt, M.D., M.P.H., Chief of Endocrinology, Cambridge Health Alliance

How and why is hypertension approached differently in the setting of diabetes? The approach to the treatment of hypertensive diabetics is different in two ways: drug selection and target blood pressure goals. With respect to drug selection, one of the major, if not the major, risk in diabetes is the development of renal failure requiring renal replacement therapy (dialysis or renal transplantation). Clinical trials have repeatedly shown that agents that disrupt the reninangiotensin-aldosterone cascade are nephroprotective in this patient population. Therefore, all diabetics (whether they are hypertensive or not, but especially if they are hypertensive) should be treated with an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, and/or direct renin inhibitor, as the foundation of their anti-hypertensive regimen. Many believe that diabetic hypertensives should be treated with two of these classes of medications simultaneously in order to maximally protect their renal function, and to prevent stroke, heart attack and death. With respect to treatment goals, we recognize that diabetes is a "cardiac risk equivalent." Patients with diabetes and especially those with concomitant hypertension (and almost always, hyperlipidemia, as well) have a cardiac risk equivalent to patients who have already sustained a myocardial infarction. Thus, we have adopted aggressive treatment goals in this patient population. In clinical trials, it has been repeatedly demonstrated that lowering the blood pressure to