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Advancing the field of closed-loop artificial pancreas research requires expert diabetologists partnering with expert mathematicians and engineers. Consortium investigators include leading endocrinologists and control theorists at top research institutions in the US and around the world. Many of the leading diabetes device manufacturers have also participated--in many cases in parallel with their own in-house closed loop research programs--providing pumps and sensors with enhanced capabilities that allow for closed-loop experiments to be performed. Consortium activities are coordinated by the Jaeb Center for Health Research, an organization with a strong track record of conducting high-impact, diabetes-related human clinical trials.
Progress to Date
Collaboration among Consortium investigators and the coordinating center has contributed to a wealth of shared resources to accelerate Consortium research, including:
- Design, optimization, and clinical testing of multiple algorithmic approaches to closed-loop control
- An in silico simulation platform, accepted by FDA, for validating candidate closed-loop control algorithms in place of animal trials
- Reusable templates for constructing the Investigational Device Exemption (IDE) regulatory documents that must be approved by FDA prior to any in-clinic computer-assisted closed-loop control research involving people
- A series of modular software platforms to support artificial pancreas research, including the UCSB/Sansum Artificial Pancreas System (APS), the UVA-developed DiAs system, and a successor to the DiAs system named inControl
- A secure Consortium Web site to host electronic case report forms (CRFs) for multicenter artificial pancreas studies, a central repository for experimental data, and interfaces to submit candidate control algorithms for centralized validation
Initial clinical research center-based studies in the mid-2000s gave way to transitional studies in a hotel or other transitional environments in the early 2010s, followed by small outpatient or in-home studies by the mid-2010s and culminating with large in-home randomized, controlled studies (RCTs) beginning in 2016/2017. These larger RCTs include several approved or planned studies that FDA considers to be pivotal device trials for artificial pancreas systems.
To be successful, the artificial pancreas must be realized and adopted. The outstanding work and considerable efforts described here must be translated into commercially available products that provide clinically meaningful improvements in glycemic control and quality of life for people with diabetes. The next phase of the JDRF Artificial Pancreas Project aims, in close partnership with industry, to drive towards this goal. Moving forward, the Consortium plans to perform groundbreaking research to include:
The prospects for an artificial pancreas are bright. NIDDK is funding a major artificial pancreas initiative in parallel with ongoing JDRF funding, and the majority of diabetes device companies have stated publicly that “closing the loop’’ is a goal. The reward for this hard work will be people with diabetes living healthier and happier lives.