IMPACT study shows FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia during glucose monitoring.- Abbott Diabetes

Abbott announced the results of the IMPACT clinical trial, which demonstrated that the FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia (low glucose levels, defined as less than 70 mg/dL1) for people with type 1 diabetes. People in the trial who used Abbott's FreeStyle Libre sensor and reader system spent 38 percent less time in hypoglycemia, as compared to people who managed their glucose with traditional self-monitoring of blood glucose (SMBG) systems (pricking a finger to draw a drop of blood that is added to a test strip inserted into a glucose meter). Data were presented at the American Diabetes Association's 76th Scientific Sessions.

Data from the study also showed that the FreeStyle Libre system reduces all measures of hypoglycemia without increasing HbA1c (an average measurement of glucose levels in the blood over the past 90 days, typically understood to be the 'gold standard' of measuring overall glucose control) versus SMBG, showing that the FreeStyle Libre system can safely and successfully replace the need for routine finger sticks as a tool for managing diabetes.

Traditional self-monitoring of blood glucose among people with both type 1 and type 2 diabetes falls short of U.S., E.U. and other key guidelines that recommend at least 4-8 self-tests per day, with the consensus that the more testing per day, the better people have an understanding of their glucose levels and can manage their diabetes accordingly. In actuality, data shows that people test less than three times per day--the biggest obstacle being the pain and hassle of routine finger sticks. But when people with diabetes do not monitor their glucose levels regularly, additional complications including hypoglycemia can become life-threatening.