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.

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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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