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“Public Workshop: Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c)”


The standard protocol for diabetes monitoring and management has been a combination of multiple daily blood sugar testing and twice a year HbA1c testing. Blood sugar testing is painful and expensive, and demands a high level of compliance to be useful. The required interval between HbA1c tests means that people with diabetes have to wait an entire six months before they can get an updated analysis of their condition.

The crucial need to develop alternate diabetes monitoring systems has now been recognized by the highest level of the scientific and medical communities. The FDA has scheduled a public workshop to give patients and industry leaders a chance to discuss the future of diabetes management. It is geared specifically towards discussing diabetes outcome measures beyond HbA1c with the aim supporting the development of “novel therapies that directly address the needs” of diabetics.

The workshop was organized in partnership with The diaTribe Foundation, JDRF, the American Diabetes Association, the American Association of Clinical Endocrinologists, and Anna McCollister-Slipp/Scripps. HCM Strategists and The diaTribe Foundation are inviting public participation by asking for submission of video clips and written comments in order to bring as many public voices to the event as possible.

The Epinex Diagnostics team is excited to have the opportunity to participate in this FDA workshop and bring our G1A test to the attention of the participants. Over a decade of scientific research has established that the use of glycated albumin (GA) as a monthly marker for diabetes management is a more effective test to monitor diabetes than HbA1c. We believe that the Epinex G1A monthly point-of-care rapid test for glycated albumin has the potential to revolutionize diabetes monitoring.

Article Source: http://www.fda.gov/Drugs/NewsEvents/ucm499281.htm

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