This morning, we announced that data from the pivotal trial of our Hybrid Closed Loop (HCL) system were published in the Journal of the American Medical Association (JAMA) and concurrently presented at the annual meeting of the European Association for the Study of Diabetes (EASD).
The data demonstrated the safety of the system and showed people with type 1 diabetes on the therapy experienced less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia, and reduced A1C compared to baseline data using sensor augmented pumps.[i] This shows the system’s ability to automate insulin dosing 24 hours a day has the potential to impact people with diabetes lives in a very meaningful way – particularly at night when it’s most challenging to maintain target blood glucose levels.[i]
Our Hybrid Closed Loop study is the first pivotal U.S. trial of closed loop technology, and the largest and longest at-home closed loop study with over 12,000 study days included in the evaluation. The system is designed to continuously drive glucose levels to a specific target 24 hours a day by tailoring insulin dosing to maximize the time glucose levels are in a healthy range. The study enrolled 124 people with type 1 diabetes ages 14 and older at 10 centers (nine in the U.S. and one in Israel).[i]
This is another exciting milestone as we make progress towards making our most advanced SmartGuard technology available to people with diabetes. Generating robust clinical evidence for our therapies is critical as we expand the reach of our therapies to people with diabetes around the world.
Medtronic Diabetes continues to lead the way in delivering the most advanced system for automated insulin delivery, bringing us closer to realizing our aspiration of commercializing the world’s first artificial pancreas. With each new advancement in our phased approach, we are enabling people with diabetes around the world to enjoy greater freedom by simplifying the disease management experience and better health through our advanced algorithms. Our commitment to enhancing quality of life for people with diabetes is a critical component in the successful treatment of this burdensome disease.
[i] Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. Published on-line ahead of print September 15, 2016 at jama.com (Online First).
Tags: artificial pancreas
, automated insulin delivery
, clinical trial
, closed loop technology
, hybrid closed loop
, integrated system
, pivotal trial