Adding to A1c

Diabetes patients and researchers are zeroing in on a collection of endpoints they say would be more useful than HbA1c for choosing among treatment options. The standard endpoint is useful in predicting serious microvascular complications of diabetes. But it does not convey any information about intraday glucose fluctuations that can affect how patients feel and function.

HbA1c measures the levels of glycated hemoglobin, which provides an estimate of average of blood glucose levels over about 2-3 months. At an FDA workshop on Aug. 29, representatives from several patient-led organizations said HbA1c is still an acceptable endpoint for approvability, but they also would like to see data on drug labels describing day-to-day or intraday glucose fluctuations outside of target ranges...