Leona M. and Harry B. Helmsley Charitable Trust Issues Consensus Report On Diabetes In Association With The ADA
In clinical and research settings, diabetes management and glycemic control are assessed using Hemoglobin A1C (HbA1C) testing, which provides a measurement of a person's mean blood glucose levels over the past three months. HbA1C is also a surrogate measure for a person's risk of developing diabetes-related complications. However, despite the tremendous value of the HbA1C to clinical management, there are limitations to what the HbA1C can tell patients and physicians about their diabetes.
The measurement does not capture short-term variations in blood glucose, exposure to hypoglycemia and hyperglycemia, or the impact of blood glucose variations on individuals' quality of life. Recent advances in type 1 diabetes (T1D) technologies and research have made it feasible to assess the efficacy of therapies and technologies using a set of outcomes beyond HbA1C, and to refine definitions of outcomes such as hypoglycemia. However, while definitions for hypoglycemia in clinical care exist, they are not standardized, causing inconsistency in the definitions used in different research studies. This impedes their use in clinical practice, as well as in the development processes for new therapies. A lack of standardized definitions also makes comparison of studies in the literature challenging and may lead to regulatory and reimbursement decisions that fail to meet the needs of people with diabetes...