FDA to Decide the Future of Diabetic Finger Pricks

On Thursday, an FDA Advisory Committee will hear discussion on allowing Continuous Glucose Monitoring (CGM) devices to be used for non-adjunctive endpoint measurement, replacing the traditional finger-prick to measure HbA1c or glucose levels in a patient’s blood. While CGM--as a medical device under the CDRH--has been used in clinical settings for a number of years, the FDA has not recommended its use in clinical trials. The EMA recommended the use of CGM in clinical studies back in 2012 because it delivers a more detailed, holistic view of an individual’s glucose levels.   Sam Osman, head of Cardiac Safety and Connected Devices at Quintiles, offered the following illustrative example: a finger-prick done twice a day is a photo snapshot of the event. The CGM is a video or continuous report that can relate information to events, if needed. Are spikes happening after eating? Is someone on the verge of slipping into a hypoglycemic coma while asleep? How much time did someone spend in target range? CGM can provide those answers. Osman also noted that the deviation range for finger-prick measures is between 15% to 20%, while CGM is deviating between 8% to 13%.   In anticipation of and in answer to clients’ increased interest in this area, Quintiles recently announced its new CGM service offering. Osman says a wearable sensor the size of a thumbnail is applied to the skin, which transmits electrical signals from the body wirelessly to a receiver or, iPhone, which is the monitoring device. The device reminds patients every seven days to change the sensor. Osman says it’s ideal for clinical studies because it fits into the patient’s lifestyle and they don’t have to remember to take a finger-prick or write down numbers right away. “We have used, or are currently using CGM in Phase I, II and III studies, with conversations around Phase IV and outcomes studies,” confirms Osman.    Sponsors are gaining interest in CGM capabilities in drug development for a number of reasons, according to Osman. Differentiations for claim labeling is a clear choice for drug developers. With the ability to monitor glucose continuously, sponsors can design trials that will inform claims that are more effective for glucose management, which in turn could impact payers’ decisions. For example, if two compounds reduce HbA1c, but one compound reduces it too much (increasing hypoglycemia risk) and the other does within the range of ideal glucose management, payers would more likely put the latter on formulary. The goal is better treatment of glucose variability and improving time in target range.   For diabetics, lowering HbA1c means less risk for a serious cardiac event, however, to be in the recommended range also equals less overall stress to the heart. Future uses of CGM include in artificial pancreas studies; post-surgery or gestational diabetes, which are situational cases; and insulin pumps where CGM could automatically adjust a patient’s insulin to the ideal range, without manual intervention.   Osman concludes, “It was the right time for us to get on the market. We think in this case, it’s good to get more data to drive better clinical decision making”