Diabetes community wants glucose control outcomes, PROs

Participants at a Monday FDA workshop to discuss diabetes outcome measures beyond hemoglobin A1c identified hypoglycemic excursions, time in glycemic range and patient-reported outcomes (PROs) as important to build a more informative picture of the absolute and comparative effectiveness of new agents.

Members of FDA, EMA, Health Canada, industry and academia, as well as patients and patient advocacy groups, said HbA1c is a useful endpoint to predict clinical benefit, but said it should be supplemented to be sensitive to excursions outside of the normal glucose range that may require acute medical care or cause burdensome symptoms. ...