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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 in Europe. Many of the leading diabetes device manufacturers have also participated, 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. Regulatory affairs are streamlined by an advisory group of experienced JDRF personnel and outside consultants, ensuring good coordination with the Food and Drug Administration and other regulatory bodies. JDRF and FDA have partnered to proactively address regulatory obstacles, and in March 2006 the FDA named the artificial pancreas one of its Critical Path initiatives.
Progress to Date
Collaboration among Consortium investigators and the coordinating center has produced 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 modular software platform -- the Artificial Pancreas System (APS) -- with a protocol-independent user interface and hooks to incorporate an arbitrary control algorithm and control various CGM and pump devices
- A secure Consortium Web site with a central repository for experimental data and interfaces to submit candidate control algorithms for centralized validation, and upload or download clinical data sets
Ongoing and recently completed in-clinic studies at the end of 2011 include investigations into hypoglycemia prediction and avoidance as well as fully-automated closed-loop control investigations using MPC and PID/PD-based algorithms. The most recent developments include the first-ever feasibility trials of portable, outpatient-based closed-loop control 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 JDRF Consortium plans to perform groundbreaking research to include:
- outpatient studies of hypoglycemia minimization "low-glucose suspend" (LGS) systems
- expanded outpatient studies of full closed-loop control systems under carefully-monitored conditions
- expanded studies of dual hormone (insulin and glucagon) devices, and methods to improve insulin kinetics
The prospects for an artificial pancreas are bright. The NIH is conducting a major artificial pancreas initiative, and the majority of diabetes device companies are participating in the JDRF Artificial Pancreas project effort and 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.