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Version 4.0 EVIDENCE VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus Recommendation Sources LE QE SR 1 Type 1 DM (short duration) Microvascular Outcomes: DCCT Research Group, 1993 I Good A Progression to non-proliferative retinopathy, microalbuminuria, neuropathy Macrovascular: Nathan et al., 2005 I-2 Fair B Myocardial infarction, stroke, cardiovascular death 3 Type 2 DM (longer duration) Microvascular: Duckworth et al., 2009 (VADT) I Good A Progression to proteinuria. Gerstein et al., 2007 ADVANCE 2008 Gaede et al., 2003 Gaede et al., 2008 Gerstein et al., 2008 2 Type 2 DM (new diagnosis) Microvascular: UKPDS 33 I Good A Progression to microalbuminuria. Macrovascular Holman et al., 2008 I-2 Fair B LE-Level of Evidence; QE = Quality of Evidence; SR = Strength of Recommendation (see Appendix A) D. Adjust the Glycemic Target According To Patient Factors OBJECTIVE Determine a target range for HbA 1 c that can be safely achieved taking into consideration individual risk, benefit, and patient’s preference. BACKGROUND The risks of therapy are different for each patient, depending upon the individual’s medical, social, and psychological status. Thus, the risks of a proposed therapy must be balanced against the potential benefits. Patients should be invited to participate in decision-making regarding glycemic targets, therapies, and goals of treatment. RECOMMENDATIONS 1. Risks of a proposed therapy should be balanced against the potential benefits, based upon the patient’s medical, social, and psychological status. DISCUSSION Factors to consider in lowering the HbA 1 c target include, but are not limited to: • Appropriate medical support and psychosocial environment • Pregnancy or the intention to become pregnant • Willingness and ability to self monitor blood glucose and to make appropriate lifestyle change Factors to consider in raising the HbA 1 c target include, but are not limited to: • History of severe, recurrent hypoglycemia • The possible consequence of adverse effects associated with hypoglycemia (e.g., consider cardiovascular disease, anticoagulation, and use of dangerous equipment) • Alcohol or substance abuse Module G: Glycemic Control Page 49
Version 4.0 VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus • The presence of multiple end-stage microvascular complications, including macular edema, proliferative retinopathy and macroproteinuria, especially with elevated serum creatinine • Symptomatic cardiovascular disease Factors that demonstrate patient preference: • Quality of life • Specific risks of patient therapeutic options E. Set a Glycemic Target Range after Discussion with the Patient OBJECTIVE Establish the patient’s readiness and willingness to achieve the target. RECOMMENDATIONS 1. The patient and provider should agree on a specific target range of glycemic control after discussing the risks and benefits of therapy. 2. The patient should be assessed for knowledge, performance skills, and barriers (e.g., psychosocial, personal, or financial), and if necessary referred to a primary care case manager or endocrine/diabetes clinic to address barriers for achieving treatment goals. DISCUSSION A target range of HbA 1 c based upon life expectancy, microvascular complications, and family history, is a starting point for shared decision making with the patient. It does not mean that a lower HbA 1 c level will not be beneficial, nor does it mean that the provider and the patient should not discuss a lower one. Rather, it implies that there are reduced benefits of excellent glycemic control in the setting of limited survival expectation or pre-existing moderate-to-advanced microvascular complications of diabetes. These factors should be taken into account when evaluating the risks and benefits of pharmacological therapy, as well as patient preferences. In addition, it should be recognized that reduction in risk from decreasing HbA 1 c is a continuum, so a target level does not have to be exactly 7.0, 8.0, or 9.0 percent. The patient should make the final decision about a specific target value of glycemic control after a full discussion of the risks and benefits of therapy with his or her provider. Providers should consider that some patients might require more immediate, urgent, or aggressive management in primary care. Some cases may require referral to an endocrine/diabetes clinic or to a case manager, in order to meet glycemic control target goals. F. Is Patient High-Risk? OBJECTIVE Identify the patient for whom consultation with, or referral to a subspecialty multi-disciplinary team would be appropriate to assist in the development of a treatment plan and/or supervise ongoing care. RECOMMENDATIONS 1. The indications to consider a consultation or referral to specialty include patients who: • Have type 1 DM; especially patients with history of hospitalizations for metabolic complications and/or patients who are receiving intensive insulin therapy • Have new-onset insulin-requiring DM • Have marked insulin resistance • Have contraindications or intolerances to medications typically used in managing diabetes • Have recurrent episodes of incapacitating hypo- and/or hyperglycemia • Have poor recognition of hypoglycemia and who have a history of severe hypoglycemic reactions (including coma, seizures, or frequent need for emergency resuscitation) • Have visual and/or renal impairment Module G: Glycemic Control Page 50
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