By Aaron J. Kowalski, Ph.D., JDRF Chief Mission Officer
Over the past few years, as commercial artificial pancreas (AP) systems have been in development, a growing number of people have used do-it-yourself (DIY) approaches to “hack” their continuous glucose monitors (CGMs) and insulin pumps to allow them to work together as an automated insulin delivery system. We’ve seen that many of those users have experienced better health outcomes as a result. But those systems, as beneficial as they can be, require some relatively sophisticated steps and are not FDA approved.
From years of studying AP technology and other automated insulin delivery systems, we’ve learned a tremendous amount about how they can benefit people with type 1 diabetes (T1D). These systems can reduce HbA1c, hypoglycemia and hyperglycemia, as well as increase time in range. They can also reduce anxiety, lessen fear of hypoglycemia and improve sleep. Those are some incredible improvements in health outcomes and quality of life for people with T1D. While we are fully committed to driving to a cure as quickly as possible, AP systems will help people until we get there.
To help make DIY AP technology more mainstream, and to ensure ease of use, consistency and safety for the people who want it, JDRF decided we are going to play a role in enabling these and other innovative solutions for people with diabetes. That’s why we are launching a new Open-Protocol Automated Insulin Delivery System Initiative.
As part of this initiative, we’re encouraging manufacturers to make open-protocol communication systems standard on devices like insulin pumps and CGMs. This would allow seamless, secure connectivity between devices – much as your cell phone and personal electronics are able to connect wirelessly. Additional participation by manufacturers will enable more choices for people with T1D so that they can use the devices that help them best manage their diabetes.
It will take cooperation, planning and effort to make this technology standard on all T1D devices. JDRF will provide guidance and some funding to help manufacturers make the transition to open-protocol technology. We will also work with community stakeholders and the Food & Drug Administration (FDA) to create a pathway toward regulating an open-protocol approach, and we will collaborate with experts to resolve legal and logistical questions that must be overcome for open-protocol systems to become widely available.
The advancement of open-protocol technology will give users of insulin-delivery devices more choices for managing their blood glucose levels and greater ability to customize their care. Because we believe in user choice, JDRF is still fully committed to the development of traditional, proprietary commercial AP technologies and the innovation of next-generation systems that will provide an even higher standard of care. At the same time, we are excited about the potential that open-protocol automated insulin systems hold for people with T1D. It’s time for this technology to move forward, and #WeAreNotWaiting to make that happen.