JDRF Celebrates Historic Artificial Pancreas Success Bringing Life-changing Benefits to People with Type 1 Diabetes

FDA Approves Medtronic Hybrid Closed Loop System

“On September 28, 2016, the type 1 diabetes (T1D) community reached a major breakthrough with the FDA’s approval of the Medtronic hybrid closed loop system. The system is the first ever approved to automate the dosing of insulin to reduce high blood sugar levels.

“The new Medtronic MiniMed 670G artificial pancreas system is a life-changing breakthrough that allows people with T1D to stay closer to their target blood sugar levels more consistently. JDRF celebrates a decade of dedicated partnership, collaboration, funding and advocacy that have made it possible to reach this landmark goal.

“Today’s announcement is a historical achievement for JDRF and the entire T1D community. After years of laying the ground work, this life-changing breakthrough is a true testament to the reason JDRF exists, which is to accelerate ways to cure, prevent and treat this disease,” said Derek Rapp, JDRF President and CEO.

“The artificial pancreas system is designed to use Medtronic’s MiniMed 670G insulin pump, 4th-generation sensors and a control algorithm to automate basal insulin delivery to maximize the time glucose levels are in a healthy range throughout the day and night. The system is fully integrated between the pump and sensor, with no need for a separate smartphone or CGM monitor. The AP system will give many people with T1D new freedom and peace of mind as for the first time, they may be able to sleep through the night without periodically waking up to check and manage their blood glucose levels.

“A study recently published in the Journal of the American Medical Association (JAMA) found that on the 670G system, 124 patients had no episodes of severe hypoglycemia or ketoacidosis over 12,389 patient days.

“Further, the 670G system kept people with T1D within their desired blood sugar range 73.4% of the time, vs. 67.8% without the system. At night, the most dangerous time for blood sugar highs and lows, the difference was even more pronounced, 76.4% in range vs. 67.8% without the system.

“Les Hazelton, who participated in one 670G trial, explains, “Bottom line: I feel better today and since going into this study, than at any point after I was diagnosed — physically, emotionally, confident in how I’m managing my diabetes. You can get emotional about it. On the good days, if there are enough of them, you recall how you feel — that’s how I feel almost every day now. That’s what it has done to help me.”

“JDRF has been pivotal in developing and pursuing its Artificial Pancreas Project since 2006. In less than 10 years, JDRF transformed the AP field, working closely with numerous partners, researchers and companies to overcome the challenges that prevented AP technology from moving forward. Together, JDRF, the Helmsley Charitable Trust, and the National Institutes of Health’s Special Diabetes Program have funded hundreds of millions of dollars in research across the globe to develop and test sophisticated computer algorithms and components needed for the AP systems. JDRF developed a roadmap to create successively advanced versions of the AP, which has been embraced by manufacturers to guide their own R&D programs. JDRF has also worked with the leadership of the Senate and House Diabetes Caucus and other allies in Congress to provide research funding through the Special Diabetes Program and overcome obstacles that could delay delivery of AP systems to people with T1D.

“JDRF funded early artificial pancreas research as part of its hypoglycemia prevention efforts, and in 2006, JDRF launched the Artificial Pancreas Consortium, made up of leading endocrinologists, mathematicians, and engineers at top research institutions in the U.S. and Europe. JDRF and the FDA partnered to proactively address regulatory obstacles, leading to the 2012 FDA guidance for artificial pancreas device systems, which provided a regulatory pathway for system commercialization.

“This month’s huge leap forward would not have been possible without the support of JDRF’s many partners, notably, the Helmsley Charitable Trust, and everyone in the T1D community who has contributed their time, energy and financial support over the last decade.

“But while this is a breakthrough, it is not the end goal. JDRF remains committed to the search for a cure and to ensure people are healthier and have a reduced diabetes management burden until we get there.

“This is a fantastic step forward, but we are not done, JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology,” said JDRF Chief Mission Officer Aaron J. Kowalski, PhD. “Next generation systems are in the pipeline that could provide even better outcomes with less burden. And our work will not be finished until we cure and prevent T1D.

“More than 10 years of hard work have brought us to this point. In the past decade, JDRF has invested more than $116 million in diverse artificial pancreas research projects, with the goal of aiding the development of multiple, reliable treatment choices for people living with T1D. With continued collaboration and support, imagine what we can accomplish next!”