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First Artificial Pancreas Outpatient Trial in the U.S. Gets FDA Approval

Published: March 28th, 2012

Category: Education and Research

Did you hear the great news about the first artificial pancreas outpatient trial in the U.S. being approved by the FDA? To help ensure that progress like the artificial pancreas continues to improve the lives of those with diabetes by simply sending an email to your members of Congress.

You can send an email to your legislators asking them to sign on to a letter acknowledging the important research contributions made by the Special Diabetes Program.

Excerpt from the JRDF statement on FDA Approves AP Trial:

NEW YORK, March 19, 2012 — JDRF applauds the recent approval by the U.S. Food and Drug Administration (FDA) of the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes (T1D). The JDRF-funded study will test an artificial pancreas (AP) system’s ability to function outside of a hospital setting, and is similar to the current outpatient trials being conducted in Europe.

The study is part of the first outpatient trials using an approach developed by the JDRF-supported Artificial Pancreas Consortium, an international research group including teams from Montpellier University Hospital (France), the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA).

“We commend the FDA for its leadership and this concrete step in meeting its commitment to accelerate the development of artificial pancreas systems. These technologies could truly transform the lives of those living with type 1 diabetes, enabling them to live longer and healthier lives, and preventing some of the personal and financial toll diabetes places on our nation,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. “While this is a small feasibility study, this is a major step forward in the field of artificial pancreas research and we congratulate the researchers and the FDA on this important milestone.”

The approval of this milestone study follows a major 18-month long effort by JDRF and allies to ensure a clear and reasonable regulatory pathway for outpatient artificial pancreas studies, and ultimately for AP systems to be approved and made available by the FDA. JDRF-funded studies have shown improved clinical outcomes from early trials of prototype AP systems.  In early 2011, JDRF proposed guidance to the FDA, based on recommendations from an external expert panel.  In the following months, over 100,000 people in the diabetes community signed JDRF’s petition, and numerous leading clinical organizations, as well as over 60 Senators and 250 Representatives joined JDRF in urging FDA to act. The FDA met its promised deadline and released draft guidance for AP systems on December 1, 2011.

For more information, please read the rest of the statement.

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