Statement from Joslin Diabetes Center on FDA Approval for Hybrid Closed Loop Insulin Delivery System
BOSTON – (September 29, 2016) – The diabetes community received exciting news yesterday with the FDA’s approval of two new devices, including the hybrid closed loop insulin delivery system and a new version of continuous glucose monitoring (CGM) for healthcare professionals.
Lori Laffel, M.D., M.P.H., is the Chief of the Pediatric, Adolescent and Young Adult Section at Joslin.
The hybrid closed loop insulin delivery system , called the MiniMed 670G, comes from Medtronic and is approved for persons with type 1 diabetes who are ages 14 years and older.
“It is extremely exciting to see these advances in diabetes technologies aimed at helping optimize glycemic control and health outcomes for persons with diabetes,” said Lori Laffel, M.D., M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section and Senior Investigator and Co-Head of the Section on Clinical, Behavioral and Outcomes Research at Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School.
The approval of the hybrid closed loop insulin delivery system was based on a pivotal, regulatory study that demonstrated safety of the system in 124 patients with type 1 diabetes who ranged from ages 14 to 75. The system consists of a pump that delivers insulin and a CGM that measures interstitial (the space between cells under the skin) glucose levels, communicating to one another wirelessly.
Insulin delivery is based upon an algorithm housed within the system. However, Dr. Laffel notes that it is important for patients and providers to understand that the system still requires substantial input from the patient with respect to inserting the insulin pump, inserting CGM, calibrating the CGM, entering information at meal/snack times in order for the system to provide insulin doses, and confirming insulin bolus doses for elevations in glucose levels.
Despite the continued need for patient input, this is an extremely exciting time for patients and providers alike with the approval of devices that aim to help simplify the lives of persons with diabetes, while at the same time improving glycemic control without increasing risk for severe hypoglycemia.
“The new system will allow better blood glucose control overnight, but still requires people with diabetes to decide on the right amount of insulin with meals and when blood sugars are high. That said, this is really a tremendous step forward and will likely usher in other systems to get approval in the near future,” said Robert A. Gabbay, M.D., Ph.D., Chief Medical Officer at Joslin Diabetes Center and Associate Professor of Medicine at Harvard Medical School. “We at Joslin have always been at the cutting edge of care and look forward to embracing this technology.”
Dr. Laffel expects future studies will be aimed at comparing the efficacy of such hybrid closed loop systems against other forms of therapy in order to assess superiority of outcomes.
The second FDA approval came for a new version of a continuous glucose monitor for healthcare professionals from Abbott, which is able to capture 14 days of continuous glucose data without any input from the patient.
“We look forward to what the future will bring for those living with diabetes, using these tools and new ones to follow,” said Dr. Laffel.