The artificial pancreas will represent the most revolutionary development in diabetes care since the discovery of insulin. JDRF is working hard to ensure that this exciting and potentially life-saving development is not delayed by unnecessary roadblocks.
JDRF has spearheaded great progress since forming the Artificial Pancreas Project (APP) in 2005, which brings together the world’s leading experts to speed the development of automated closed-loop systems. Since then, JDRF has made significant investments in research funding toward advancing this technology, and numerous in-hospital artificial pancreas studies have demonstrated that this innovative technology can improve glucose control. More recently, studies outside of the hospital are beginning to show that people with type 1 diabetes (T1D) can successfully use these systems. Additionally, advancing the artificial pancreas could prevent costly complications that are burdening our economy – a recent study by leading health economics experts showed that an artificial pancreas could save Medicare nearly $1 billion over the next 25 years. Thanks to this significant research progress, there is overwhelming consensus among researchers, clinicians, and patients that testing of this technology should continue so that it is soon available to people with T1D.
The ‘artificial pancreas’ (AP) is a transformational technology and one that is urgently needed by patients. The artificial pancreas combines a ‘continuous glucose monitor’ (CGM) and an insulin pump with sophisticated computer software to provide just the right amount of insulin at just the right time. Artificial pancreas technologies could truly transform the lives of those living with T1D, enabling them to live longer and healthier lives and preventing some of the personal and financial toll diabetes places on our nation. JDRF is accelerating multiple generations of an artificial pancreas that, over time, will more and more closely mimic the functions of the pancreas of someone without diabetes. The technology will be especially helpful overnight, when 50 to 70 percent of hypoglycemic emergencies (dangerous low blood sugar) occur. Even with diligent monitoring, the majority of people with type 1 diabetes still spend many hours a day outside healthy blood sugar levels. While the artificial pancreas is not a biological cure for diabetes, it will reduce dangerous high and low blood sugars, providing a better quality of life now for those suffering from the disease, and helping lower the risk of developing complications.
JDRF’s goal is to speed the development, regulatory approval, clinician adoption and health insurance coverage of effective artificial pancreas technologies. To do so, JDRF is:
As work on the AP research front progressed, JDRF recognized the need for a clear and reasonable regulatory pathway. To address this issue, in 2010, JDRF convened a clinical panel to develop a regulatory roadmap, or “guidance,” and proposed it to FDA. To encourage FDA adoption, JDRF mobilized clinicians, key Members of Congress, and the entire nationwide T1D community. In just 23 days in the fall of 2011, over 100,000 individuals signed a petition for the FDA to advance, not delay, the development of an artificial pancreas – and U.S. Senators, clinicians and people with type 1 diabetes urged FDA to issue clear and reasonable guidance on the artificial pancreas. Watch video coverage of the press conference here. Also, JDRF ran a print ad in The New York Times and The Washington Post, on November 2, 2011.
In November 2012, FDA issued a final artificial pancreas guidance that provides, for the first time, researchers and industry with a clear and reasonable road map of the FDA’s expectations for conducting human studies of artificial pancreas systems, and for their approval for marketing to people with diabetes.
The final guidance includes some very important elements. It allows for a range of scientifically valid study designs, allowing flexibility that will encourage innovation in technologies for people with T1D while ensuring thorough evaluation of such systems before they can be prescribed by doctors. For example, the guidance recognizes “time in range” as a potential endpoint to use in artificial pancreas studies, as well as other measures of glucose control. It allows sponsors the ability to propose statistical measures of efficacy tailored for their systems, and accepts the use of continuous glucose monitoring (CGM) data in evaluating artificial pancreas systems.
Early on in the Artificial Pancreas Project, JDRF conducted the world’s largest clinical trial to test the effectiveness of continuous glucose monitors (CGMs), which are an integral part of the AP system. The trial established the therapeutic value of CGMs in promoting improved blood glucose control. Largely as a result of this trial and JDRF engagement with health care leaders, clinical guidelines now recommend CGMs and insurance companies cover them as a regular part of diabetes care.
By 2014, more than 95% of private health plans cover CGMs, but Medicare does not. JDRF believes Medicare beneficiaries should have access to these important, beneficial therapies that virtually all other people with insurance do, and is working with allies to fight for Medicare CGM coverage.
Again, JDRF is working hard to ensure that this exciting and potentially life-saving development is not delayed by unnecessary roadblocks. The artificial pancreas represents the most revolutionary development in diabetes care since the discovery of insulin, and JDRF will continue to work towards the wide availability of this to people with T1D.