Diabetes Artificial Pancreas FDA Approval Plan Finally Outlined


After years of delays, it looks like the FDA is finally outlining a plan to make the artificial pancreas a reality for type 1 diabetics. Yesterday, the organization set forth design and testing recommendations that scientists and device manufacturers should follow in order to speed up the approval process. While safety is of the utmost importance, the FDA has clearly been slow moving in seeing the device to market, especially given the fact that similar devices, such as Medtronics Minimed Paradigm Veo, have been available in Europe for several years. The Veo doesn’t completely close the loop between blood sugar levels and insulin response, but it does suspend insulin delivery temporarily when a user’s blood sugar level drops too low.

According to the FDA, computer glitches, device problems and issues with the insulin used have kept them from moving forward. The FDA has approved more than 20 clinical studies surrounding the artificial pancreas. Until now, the approval of these studies has perhaps been the most positive development in seeing that the device gets into the hands of the three million Americans suffering from type 1 diabetes.

What prompted the FDA to offer its approval guidelines for the device? In early November, the JDRF (Juvenile Diabetes Research Foundation), along with health professionals and lawmakers, including Senator Susan Collins (R-ME) who is the co-chair of the Senate Diabetes Caucus, went to Washington, D.C. to urge the FDA to take the necessary action to see that the device becomes a reality.

If you are not familiar with what exactly an artificial pancreas is, it is not an internal device. Like an insulin pump, it is a portable device that closes the loop between blood sugar testing and insulin delivery (or suspension). The artificial pancreas reacts to a patient’s current blood sugar levels and adjusts insulin delivery as needed.

2 Responses to “Diabetes Artificial Pancreas FDA Approval Plan Finally Outlined”

  1. Rosa Ashton says:

    My 19 year old daughter was diagnosed with type 1 diabetes when she was 10. She has found it a struggle to manage blood sugar levels with injections. How can she get hold of an artificial pancreas that you write about?



    • Kev says:

      Rosa, the artificial pancreas is not yet available. Does your daughter use an insulin pump? I used to be on injections and switching to the pump helped me to stabilize my blood sugar levels. I also drastically adjusted my diet. Those are two ideas that worked for me.

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