Diabetes Self-Management Blog

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.

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.

POST A COMMENT       
  

Comments
  1. Will Medicare cover the use of this new device?

    Posted by Emma |
  2. 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.

    Posted by Ferne |
  3. 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

    Posted by Connie Heyerdahl |
  4. What about those of us who use other insulin pumps? Is this affordable?

    Posted by Ann Martin |

Post a Comment

Note: All comments are moderated and there may be a delay in the publication of your comment. Please be on-topic and appropriate. Do not disclose personal information. Be respectful of other posters. Only post information that is correct and true to your knowledge. When referencing information that is not based on personal experience, please provide links to your sources. All commenters are considered to be nonmedical professionals unless explicitly stated otherwise. Promotion of your own or someone else's business or competing site is not allowed: Sharing links to sites that are relevant to the topic at hand is permitted, but advertising is not. Once submitted, comments cannot be modified or deleted by their authors. Comments that don't follow the guidelines above may be deleted without warning. Such actions are at the sole discretion of DiabetesSelfManagement.com. Comments are moderated Monday through Friday by the editors of DiabetesSelfManagement.com. The moderators are employees of Madavor Media, LLC., and do not report any conflicts of interest. A privacy policy setting forth our policies regarding the collection, use, and disclosure of certain information relating to you and your use of this Web site can be found here. For more information, please read our Terms and Conditions.


Tools & Technology
FDA Approves Remote Glucose-Monitoring Technology (10/23/14)
Information at Our Fingertips (09/04/14)
Support Medicare Coverage of CGMs (09/02/14)
Children With Diabetes "Focus on Technology" Conference (07/28/14)

Diabetes News
FDA Approves Remote Glucose-Monitoring Technology (10/23/14)
Can Grapefruit Juice Prevent Weight Gain, Increase Insulin Sensitivity? (10/16/14)
Low-Carb Diet Improves Quality of Life in Type 2 Diabetes (10/07/14)
Long Hours at Low-Income Jobs Linked to Increased Diabetes Risk (10/02/14)

Diane Fennell
FDA Approves Remote Glucose-Monitoring Technology (10/23/14)
Take Part in the Big Blue Test! (10/15/14)
Can Grapefruit Juice Prevent Weight Gain, Increase Insulin Sensitivity? (10/16/14)
Low-Carb Diet Improves Quality of Life in Type 2 Diabetes (10/07/14)

 

 

Disclaimer of Medical Advice: You understand that the blog posts and comments to such blog posts (whether posted by us, our agents or bloggers, or by users) do not constitute medical advice or recommendation of any kind, and you should not rely on any information contained in such posts or comments to replace consultations with your qualified health care professionals to meet your individual needs. The opinions and other information contained in the blog posts and comments do not reflect the opinions or positions of the Site Proprietor.