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TITLE: Rapid Hemoglobin A1c Testing for Evaluationof Glucose ControlAUTHOR: Jeffrey A. Tice, MDAssistant Adjunct Professor of MedicineDivision of General Internal MedicineDepartment of MedicineUniversity of CA, San FranciscoPUBLISHER NAME: California Technology Assessment ForumDATE OF PUBLICATION: October 8, 2003PLACE OF PUBLICATION: San Francisco, CA
 
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RAPID HEMOGLOBIN A1C TESTING FOREVALUATION OF GLUCOSE CONTROL
INTRODUCTION
The California Technology Assessment Forum is requested to review thescientific evidence for the use of rapid hemoglobin A1c (HbA1c) testingin the clinic and home settings.
BACKGROUND
Diabetes mellitusDiabetes has been classified into type 1 diabetes mellitus, characterized bylack of insulin production, and type 2 diabetes, characterized by insulinresistance. An estimated 17 million people in the United States are knownto have diabetes mellitus, of which 1.4 million have type 1 diabetes.Current management guidelines recommend target pre-prandial (pre meal) blood glucose values of 90 to 130 mg per deciliter, peak post-prandial(after meal) blood glucose values <180 mg per deciliter, and hemoglobinA1c (HbA1c) levels of 
≤
7.0% (American Diabetes Association 2003).Chronically uncontrolled hyperglycemia leads to a wide range of adversehealth outcomes including retinopathy, nephropathy, neuropathy, andcardiovascular disease. These complications result in significant morbidityand mortality for patients with diabetes. Strategies to prevent or reduce theoccurrence of secondary diabetic complications have been intensivelystudied.Intensive management of glucose levelsTwo large randomized controlled trials demonstrated that intensivemanagement of blood glucose levels reduced the rate of diabeticcomplications compared with conventional management. However,intensive management was also associated with a three-fold increase in therate of severe hypoglycemic events. Intensive management of diabetesmellitus consists of three or more daily injections of insulin, use of aninsulin pump, or use of oral agents to achieve normoglycemia.
 
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BACKGROUND,
continued
The Diabetes Control and Complications Trial (DCCT).
The Diabetes Control and Complications Trial randomized 1441 patientswith insulin-treated diabetes into either intensive management or conventional therapy (Diabetes Control and Complication Research Group1993). The primary endpoint was diabetic retinopathy. Secondaryoutcomes included renal, neurologic, cardiovascular, andneuropsychological outcomes and adverse effects associated with thetreatment regimens.Patients in the DCCT had a mean age of 27 years and were followed for an average of 6.5 years. At baseline, the median HbA1c level was 8.9%. Inthe intensive treatment arm, HbA1c dropped to median of about 7% while patients in the usual care group maintained a median HbA1c of 9%.Patients without retinopathy at baseline who received intensive glucosemanagement had a 76% (95% CI: 62-85%) reduction in retinopathycompared to patients randomized to usual care. Among participants withretinopathy at baseline who were randomized to intensive therapy, therewas a 54% (95% CI: 39-66%) reduction in progression of retinopathy.Furthermore, intensive therapy significantly reduced the risk of microalbuminuria (39%), albuminuria (54%), and clinical neuropathy(60%). The incidence of major cardiovascular and peripheral vascular events was low as expected in this young cohort (0.5 events per 100 person-years vs. 0.8 events, RR 0.59, 95% CI 0.32-1.10). Mortality wasnot reduced by intensive therapy. A trend towards more deaths in theintensively treated group was observed (7 deaths among those randomizedto intensive therapy vs. 4 deaths in the usual care group).Intensive therapy was associated with more than a three-fold increasedrisk of severe hypoglycemia defined as an episode with symptomsconsistent with hypoglycemia in which the patient required the assistanceof another person and was associated with a blood glucose level < 50mg/dl and prompt recovery after therapy for hypoglycemia. The rate of severe hypoglycemia was 62 episodes per 100 person-years in theintensive therapy group versus 19 episodes per 100 person-years in theusual care group. During 5 years of follow-up, 60% of patients in theintensive therapy group experienced at least 1 severe hypoglycemic eventand 36% experienced 3 or more.
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