Patients who report clear symptoms of hypoglycemia but have no blood glucose readings can be classified as having ”probable symptomatic hypoglycemia,” according to a new task force report from two specialty groups.
The updated hypoglycemia classification should foster more accurate reporting in clinical trials, John Anderson, MD, president of medicine and science for the American Diabetes Association (ADA), told MedPage Today.
”Now there is a bucket to put these patients in,” Anderson said during a phone interview, noting that these cases can easily be discounted in clinical trials.
The ADA and The Endocrine Society jointly published the task force report online in their respective journals, Diabetes Care and the Journal of Clinical Endocrinology and Metabolism.
Anderson noted that the other categories of hypoglycemia — severe, symptomatic, and asymptomatic — remain largely the same as those published in a 2005 task force report.
In addition to probable symptomatic hypoglycemia, the group also added a pseudo-hypoglycemia category, which is defined as reported hypoglycemic symptoms with a blood sugar reading above 70 mg/dL.
Anderson said the update was largely driven by data from the ACCORD trial, which found a higher risk of death for patients who were pushed to lower targets for blood glucose control — with hypoglycemia being the likely culprit.
It was also prompted by the availability of newer antidiabetic agents that have come on the market since 2005 and carry a lower risk of hypoglycemia, but at a higher price tag than older agents that make patients more prone to low blood sugar.
”Both societies thought it was a good time to take a fresh look back over 7 years’ worth of new data,” Anderson said, adding that the 10-member task force debated the document over a period of 9 months.
The report also emphasizes the need for tailored approaches to treatment as highlighted in the ADA and EASD diabetes managment guidelines published last year, with a focus on children and the elderly, for whom hypoglycemia can have more serious consequences.
And it provides tools to help patients and clinicians incorporate hypoglycemia reporting into routine clinic visits: ”Patients may have hypoglycemia, but no one is asking about it,” Anderson said, pointing to the ”hypoglycemia patient questionnaire” included in the report.
From www.medpagetoday.com
Primary source: Diabetes Care
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.
____
Läs hela artikeln utan lösenord på
Diabetes Care Publish Ahead of Print, published online April 15, 201
http://care.diabetesjournals.org/content/early/2013/04/12/dc12-2480.full.pdf+html
Nyhetsinfo
www red DiabetologNytt
