Type I diabetes comes with a lifetime commitment to maintaining health. Patients have to measure blood glucose levels and adjust insulin levels as necessary as indicated by multiple finger stick blood tests daily. Glucose monitors can reduce the number of finger sticks to two a day for calibration to be sure the monitor is working accurately. Any progress in maintaining or improving blood glucose management with less personal attention is a win. On that basis, testing completed and reported on earlier this month by medical device giant Medtronic is a huge win.
Medtronic’s successful test of its hybrid closed-loop (HCL) insulin delivery system was deemed safe, acceptable, and associated with improved glucose control during extended at-home use. In its role as a substitute for the human pancreas, the HCL system was tested with 124 subjects who have Type I diabetes. All were 14 years old or older, 55 were male and 69 female. During the test, the patients needed to do only one finger stick a day, for calibration measurements. In three months of testing with the system — a total of 12, 389 patient days — no diabetic ketoacidosis (DKA), severe hypoglycemia, or serious device-related adverse events were reported. At the end of the study, 99 of the patients opted to remain in a continued-access program.
At this time, the Medtronic HCL is approved for investigative use only in the U.S. The results of the test were reported at the 76th Scientific Sessions of the American Diabetes Association in New Orleans earlier this month. At that time Richard M. Bergenstal, M.D., of the International Diabetes Center in Minneapolis said, “The ability for people with diabetes to achieve better glucose control and live longer, healthier lives has significantly improved with insulin pumps and continuous glucose monitoring systems. However, patients must still make frequent decisions each day while using today’s systems. Simplifying this self-management and adding a little peace of mind with this more automated Hybrid Closed Loop system would impact these patients’ lives in a very meaningful way.” Once FDA clears the system, it could have a major positive impact on the lives of diabetics.