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Insulin pump with infusion set. Photo by Mbbradford at en.wikipedia [Public domain], from Wikimedia Commons. |
FDA today received a petition urging the administration to issue “clear and reasonable” gui dance for development of an artificial pancreas.
More than 100,000 people throughout the United States signed the petition, which was launched by the Juvenile Diabetes Research Foundation International (JDRF), an organization that funds research to develop a cure for type 1 diabetes, on October 3. The issuing of FDA guidance, the group says, will open the door for further development, testing, and approval of the artificial pancreas.
“The FDA owes it to the diabetes community to issue guidance that honors the petition of the 100,000 signers,” JDRF president and CEO Jeffrey Brewer said in a press release. “If the FDA fails to issue guidance outlined in this petition, patient access will inevitably be delayed. Today Americans are deprived of potentially life-saving insulin pumps with safety features like low glucose suspend, available in the rest of the world for more than 3 years. We don’t want to see the same happen with artificial pancreas systems in the future.”
The artificial pancreas, still in prototype form, is an external device that can control blood sugar through the use of a continuous glucose monitor and an insulin pump paired with software that controls when and how much insulin is provided. The device’s development is a top priority of the JDRF.