JDRF/NIDDK Artificial Pancreas Project Consortium
History and Purpose
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, providing pumps and sensors with enhanced capabilities that allow for closed-loop experiments to be performed.
Multicenter 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. In March 2006 FDA named the artificial pancreas one of its Critical Path initiatives. In November 2012, following a period of strong engagement with JDRF and other advocates, FDA released a guidance document defining a regulatory pathway for artificial pancreas studies and product approval.
In September 2016, the type 1 diabetes (T1D) community reached a major breakthrough with FDA's approval of the Medtronic 670G hybrid closed loop system. The system is the first ever approved to automate the dosing of insulin to reduce high blood sugar levels.
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