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Standardized definitions for outcome measures beyond A1c for patients with type 1 diabetes

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Dr KK Aggarwal    24 November 2017

A new joint consensus statement from the American Association of Clinical Endocrinologists AACE American Association of Diabetes Educators AADE American Diabetes Association ADA Endocrine Society JDRF International Leona M and Harry B Helmsley Charitable Trust Pediatric Endocrine Society and T1D Exchange standardizes definitions for clinically meaningful outcome measures beyond HbA1c for patients with type 1 diabetes. Glycosylated hemoglobin or HbA1c is a commonly used parameter to evaluate glycemic control as it provides a measurement of the mean blood glucose levels over the past three months. A1c is also a surrogate measure for a person s risk of developing diabetes related complications. According to the statement there are limitations to what the HbA1C can tell patients and physicians about their diabetes such as it does not detect short term variations in blood glucose exposure to hypoglycemia and hyperglycemia or the impact of blood glucose variations on the quality of life of the patient. Recent advances technologies such as continuous glucose monitoring CGM have made it feasible to assess the ef 64257 cacy of therapies and technologies using a set of outcomes beyond HbA1c in type 1 diabetes. The statement says that while hypoglycemia has been defined in clinical care these definitions are not standardized. Published online November 21 2017 in the journal Diabetes Care the consensus statement has developed definitions for outcomes beyond HbA1c including hypoglycemia hyperglycemia time in range and diabetic ketoacidosis DKA in type 1 diabetes. Three levels of hypoglycemia have been defined Level 1 hypoglycemia Measurable glucose concentration 70 mg dL 3.9 mmol L but 8805 54 mg dL 3.0 mmol L that can alert a person to take action. Level 2 hypoglycemia Measurable glucose concentration 54 mg dL 3.0 mmol L that needs immediate action. Level 3 hypoglycemia Severe event characterized by altered mental and or physical status requiring assistance. Two levels of hyperglycemia have been defined Level 1 Eevated glucose glucose 180 mg dL 10 mmol L and glucose 8804 250 mg dL 13.9 mmol L Level 2 Very elevated glucose glucose 250 mg dL 13.9 mmol L Time in range has been defined as percentage of readings ranging from 70 180 mg dL 3.9 10.0 mmol L per unit of time. CGM is used to obtain data from which time in range can be derived. Diabetic ketoacidosis Elevated serum or urine ketones greater than the upper limit of the normal range and Serum bicarbonate 15 mmol L or blood pH 7.3 Source ADA Press Release Diabetes Care. 2017 Dec 40 12 1622 1630

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