Combined Insulin Pump and Glucose Monitoring System Approved

In another step toward an artificial pancreas, the US Food and Drug Administration (FDA) recently approved Medtronic’s MiniMed Paradigm REAL-Time Revel System, the only product on the US market that combines an insulin pump and continuous glucose monitoring (CGM) technology into a single device.


Using an electrode inserted under the skin, the MiniMed Paradigm REAL-Time Revel System measures glucose levels in the interstitial fluid (the fluid between cells) and displays updated glucose levels every 5 minutes. The system can alert the user to rapid changes in blood glucose levels and can also provide predictive alerts warning of impending high or low blood glucose up to 30 minutes in advance so that corrective or preventive action can be taken. (A conventional blood glucose check is required to confirm the CGM data before making any treatment adjustments.) The device does not automatically suspend or change the amount of insulin being delivered. The user must still do this manually.

Highlighted features on the insulin pump include an insulin delivery amount of as little as 0.025 units per hour and the option of a 1:1 carbohydrate ratio setting, useful for people who are relatively insulin resistant.

According to William Tamborlane, MD, chief of pediatric endocrinology at Yale University School of Medicine, “Recent clinical evidence clearly supports that insulin pump therapy combined with continuous glucose monitoring improves patients’ A1C while reducing the relative risk of severe hypoglycemia.”

The system, which is for use in people with Type 1 or Type 2 diabetes who are 18 years old or older, is available immediately. (A separate pediatric model is available for children ages 7–17.)

To learn more about the MiniMed Paradigm REAL-Time Revel System, read the article “FDA Approves Combined Diabetes Management System,” see the product information pages on the Medtronic Web site, or contact the manufacturer at (866) 948-6633.

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  • Willie Cowart

    Do the Veterans Administration use this pump system?

  • Will Ryan

    Let’s hear it for Medtronic (MiniMed)! I’ve wanted a CGM for a long time and now all I need is for Medicare to approve it.

  • Hugh Stepaniuk

    Great news, I have used the Paradigam pump for 3 years and it has been a great help in my Diabetis control. Would like to get a CGM but our great Medicare system need to get on board and approve the cost as a benifit.
    Goog work Medtronic.

  • John Shiffler

    It took me 9 months fighting with my insurance and finally going to binding arbitration to get the CGM and supplies approved, but it was worth the fight!

    On days that I don’t use the CGM (rare), I miss the convenience of being able to look at my pump display and getting an idea of where I’m at glucose-wise.

    If anyone can get this and can get your insurance or Medicare to cover it, it is an incredible help. My A1C have been much better since I got this.

  • Steve Baughn

    I recently acquired a Blackberry Storm. I am looking for a good app to log bg, carbs, and insulin. I am on a mini med pump for 8 months and I find it difficult to carry a pad and pen to log. Can someone help me.

  • amber

    steve baughn: you can sync your meter and pump together so all the glucose results are stored in your pump. then you can download the pump to the minimed web site and print them out.

  • carole

    finally got on a pump but was shocked to find out medicare will not pay for the cgms. This is like approved wear of one shoe without the other. My fingers are all pricked and sore. It’s so difficult to try and get everything organized without this piece to the puzzle but it’s understandable. Look how much money the drug companies make on those strips!!! What if everyone just had a cgms .. wow. Make quite a difference I think…Come on Medicare, step out of the dark ages.