FDA Approves First-Generation Artificial Pancreas System

On September 27, the US Food and Drug Administration (FDA) announced the approval of the MiniMed 530G with Enlite, a first-generation artificial pancreas system that automatically shuts off insulin delivery when blood glucose levels drop too low.

The approval represents the first step toward a fully automated, closed-loop artificial pancreas that would control blood glucose levels without requiring user intervention.

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The MiniMed 530G with Enlite, an integrated insulin pump and continuous glucose monitoring system, is the first device approved in the United States with “threshold suspend” — the ability to suspend insulin delivery when glucose levels have fallen too low. When glucose levels reach a predetermined hypoglycemia (low glucose) threshold — which can be set by a health-care provider from anywhere between 60 mg/dl and 90 mg/dl — the system will sound an alarm. If the user is sleeping or otherwise cannot respond to the warning, the device will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.

According to Medtronic, the Enlite sensor (which detects glucose levels) is 31% more accurate than previous sensors and, in tests, it has been able to detect up to 93% of hypoglycemic episodes. The Enlite sensor can be worn for up to six days.

“The diabetes community has eagerly awaited approval of this system that stops insulin delivery when sensor glucose values fall below a predetermined threshold,” said Richard M. Bergenstal, MD.

The MiniMed 530G with Enlite is approved for people with diabetes ages 16 and up. It will be available within the next few weeks at a retail price of $7,350; those with insurance will generally pay from $500 to $1,200 out of pocket, according to Medtronic.

To learn more about the MiniMed 530G with Enlite, read the press release on the Medtronic Web site or see the device’s official site.

  • Emma

    Will Medicare cover the use of this new device?

  • Ferne

    Not only Medicare but the Affordable Health Act? I’ve read that the elderly won’t be getting much treatment and in an article I just read it advised those on Medicare to have cataract surgery, hip replacements etc before Jan. 1st. I am concerned that I won’t get all the necessary blood tests I need every month for blood diseases and since one is terminal I might be considered untreatable.

  • Connie Heyerdahl

    I am a diabetic that takes 5 shots a day and was going to have a pancreas transplant years ago and I could not get it. I have been told I have type 1 and I really want to see if I can have this surgery so if anyone can help me. Thank you

  • Ann Martin

    What about those of us who use other insulin pumps? Is this affordable?