American Diabetes Association Issues Hypoglycemia Position Statement
November 22, 2016
Levels to be reported during clinical trials defined, based upon recommendations by International Hypoglycemia Study Group
Hypoglycemia is a condition characterized by abnormally low blood glucose, which in extreme cases can lead to unconsciousness and death. It's an important health consideration for people with diabetes as well as for researchers studying the treatment of diabetes. The American Diabetes Association has joined with the European Association for the Study of Diabetes (EASD) to issue a hypoglycemia position statement containing recommendations for identifying hypoglycemia and for reporting hypoglycemia in clinical studies.
The detailed statement is featured in the article "Glucose Concentrations of <3.0 mmol/l (54 mg/dl) Should Be Reported in Clinical Trials," to be published in the January 2017 issue of Diabetes Care, and online on November 21, 2016. The article is being simultaneously published in Diabetes Care by the American Diabetes Association and in Diabetologia by the European Association for the Study of Diabetes.
The International Hypoglycemia Study Group—a team of international experts in the field of diabetes and endocrinology—examined current research on hypoglycemia to create proposed hypoglycemia levels and recommended what levels should be reported during clinical trials. The lack of a standard hypoglycemia value made it difficult in clinical studies to compare the effects on hypoglycemia of different insulins and other medications, educational interventions or new technologies.
"We formed our multi-disciplinary group three years ago with a goal to increase awareness of hypoglycemia as a major side effect of current treatment in diabetes by educational activities among the diabetes community—including patients, their families and professionals—to benefit patient care," said corresponding author of the article, Simon R. Heller, professor of clinical diabetes, University of Sheffield, and director of research and development and honorary consultant physician, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, U.K. "We developed the idea that a re-classification of hypoglycemia would be useful and are delighted that both the American Diabetes Association and EASD have agreed."
The International Study Group suggests that a level of <3.0 mmol/l (54mg/dl) be defined as denoting serious clinically important hypoglycemia, whether that level is associated with symptoms or not, and that incidences of hypoglycemia within that range be reported during clinical trials and in clinical practice.
The statement outlines proposed glucose levels to define severe hypoglycemia as:
- Level 1: A glucose alert value of 3.9 mmol/l (70 mg/dl) or less. This need not be reported routinely in clinical studies, although this would depend upon the purpose of the study.
- Level 2: A glucose level of <3.0 mmol/l (<54 mg/dl) is sufficiently low to indicate serious, clinically important hypoglycemia.
- Level 3: Severe hypoglycemia, as defined by the American Diabetes Association, denotes severe cognitive impairment requiring external assistance for recovery.
The complete statement will be published online at http://dx.doi.org/10.2337/DC16-2215 on Nov. 21, 2016.
About Diabetes Care®
Diabetes Care is a monthly journal of the American Diabetes Association to increase knowledge, stimulate research, and promote better health care for people with diabetes. To achieve these goals, the journal publishes original articles on human studies in the following categories: clinical care, education and nutrition; epidemiology, health services; and psychosocial research; emerging treatments and technologies; and pathophysiology and complications. The journal also publishes the Association's recommendations and statements, clinically relevant review articles, editorials and commentaries. Topics covered are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators and other health professionals. Diabetes Care is the highest-ranked, peer-reviewed journal in the field of diabetes treatment and prevention.
About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation’s leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn)