Abstract and Introduction
Abstract
Objective—To review the evidence about the impact of hypoglycemia on patients with diabetes that has become available since the past reviews of this subject by the American Diabetes Association and The Endocrine Society and to provide guidance about how this new information should be incorporated into clinical practice.
Participants—Five members of the American Diabetes Association and five members of The Endocrine Society with expertise in different aspects of hypoglycemia were invited by the Chair, who is a member of both, to participate in a planning conference call and a 2-day meeting that was also attended by staff from both organizations. Subsequent communications took place via e-mail and phone calls. The writing group consisted of those invitees who participated in the writing of the manuscript. The workgroup meeting was supported by educational grants to the American Diabetes Association from Lilly USA, LLC and Novo Nordisk and sponsorship to the American Diabetes Association from Sanofi. The sponsors had no input into the development of or content of the report.
Evidence—The writing group considered data from recent clinical trials and other studies to update the prior workgroup report. Unpublished data were not used. Expert opinion was used to develop some conclusions.
Consensus Process—Consensus was achieved by group discussion during conference calls and face-to-face meetings, as well as by iterative revisions of the written document. The document was reviewed and approved by the American Diabetes Association's Professional Practice Committee in October 2012 and approved by the Executive Committee of the Board of Directors in November 2012 and was reviewed and approved by The Endocrine Society's Clinical Affairs Core Committee in October 2012 and by Council in November 2012.
Conclusions—The workgroup reconfirmed the previous definitions of hypoglycemia in diabetes, reviewed the implications of hypoglycemia on both short- and long-term outcomes, considered the implications of hypoglycemia on treatment outcomes, presented strategies to prevent hypoglycemia, and identified knowledge gaps that should be addressed by future research. In addition, tools for patients to report hypoglycemia at each visit and for clinicians to document counseling are provided.
Introduction
In 2005, the American Diabetes Association Workgroup on Hypoglycemia released a report entitled "Defining and Reporting Hypoglycemia in Diabetes". In that report, recommendations were primarily made to advise the U.S. Food and Drug Administration (FDA) on how hypoglycemia should be used as an end point in studies of new treatments for diabetes. In 2009, The Endocrine Society released a clinical practice guideline entitled "Evaluation and Management of Adult Hypoglycemic Disorders," which summarized how clinicians should manage hypoglycemia in patients with diabetes. Since then, new evidence has become available that links hypoglycemia with adverse outcomes in older patients with type 2 diabetes and in children with type 1 diabetes. To provide guidance about how this new information should be incorporated into clinical practice, the American Diabetes Association and The Endocrine Society assembled a new Workgroup on Hypoglycemia in April 2012 to address the following questions:
How should hypoglycemia in diabetes be defined and reported?
What are the implications of hypoglycemia on both short- and long-term outcomes in people with diabetes?
What are the implications of hypoglycemia on treatment targets for patients with diabetes?
What strategies are known to prevent hypoglycemia, and what are the clinical recommendations for those at risk for hypoglycemia?
What are the current knowledge gaps in our understanding of hypoglycemia, and what research is necessary to fill these gaps?