Artificial pancreas (AP) systems “close the loop” between continuous glucose monitors and insulin pumps, using a computer algorithm to calculate and administer insulin. A new pilot trial published in Diabetes Technology and Therapeutics shows that using a newly designed smartphone app, an AP system can wirelessly connect with different brands of continuous glucose monitors (CGMs), insulin pumps and algorithms to reliably control blood glucose levels.
While small in scale, the study represents the first clinical evaluation of an interoperable artificial pancreas system (iAPS), and was performed as part of an FDA investigational device exception study.
The iAPS “provides a path forward for testing and clinical evaluation of an interoperable AP with modern peripheral devices and state-of-the-art algorithms,” according to the study’s research team from Harvard University, Sansum Diabetes Research Institute, Labrasoft and Joslin Diabetes Center.
An AP system that is comprised of interoperable components, meaning it can connect and work with different devices regardless of manufacturer, has been a longtime goal of advocates for people with type 1 diabetes (T1D), since it comes with such high potential for increased choice and thus enhanced quality of life. Breakthrough T1D has supported multiple studies, such as one recently published in The Lancet, which demonstrates that AP systems offer better glycemic control than other treatment alternatives; however, AP system device interoperability remains a frontier. To this end, Breakthrough T1D’s Open Protocol Initiative supports the development of AP technology that allow devices to “talk” with one another, regardless of whether they have the same manufacturer.
In the iAPS study, participants were instructed to challenge the system by eating out at restaurants, walking extensively, and using the system overnight. Researchers then evaluated how long iAPS stayed connected and the amount of time spent within healthy glucose ranges compared to a previous week of sensor-augmented pump use. The iAPS app demonstrated a non-significant improvement in target glucose range time when compared to the use of a sensor-augmented pump alone, and was significantly more effective at keeping users above a low blood sugar reading of 70 mg/dL.
The study authors have previously been funded by several Breakthrough T1D grants, which helped them develop the iAPS app. This pilot demonstrates the platform is suitable for use in clinical trials. Their future work will focus on refining the system around user acceptance and its evaluation in real-life environments.
Breakthrough T1D is proud to fund researchers working to improve the quality of life for people with T1D, and we are excited by the continued development of artificial pancreas technology. To learn more about the groundbreaking research Breakthrough T1D is funding to automate blood-sugar management, click here.
