Medtronic's Insulin Pump with Glucose Monitor Gets FDA Approval

In a healthy person, the body senses insulin need and dispenses the hormone without the person's conscious thought or action. Future technologies may one day be able to mimic this unconscious sensing and dispensing of insulin for people with diabetes.

Last week, medical science moved a step closer to such a "closed loop" system with the FDA's approval of Medtronic's insulin pump and glucose monitoring system.

The MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System sends glucose readings every 5 minutes from a sensor to the pump. These continuous readings allow a user to monitor their glucose throughout the day. The system includes an alarm that vibrates or sounds when blood glucose is too high or too low, especially useful when sleeping. Action can be taken to improve glucose levels after a fingerstick confirmation.

"Integrating an insulin pump with REAL-Time CGM is a major step toward the development of a “closed-loop” insulin delivery system that may one day mimic some functions of the human pancreas."
- Medtronic's press release

MiniMed's REAL-Time System is shown at right:
A - Insulin pump
B - Insulin delivery
C - Glucose sensor
D - Transmitter

If you're interested in just continuous glucose monitoring (CGM) without a pump, MiniMed currently sells the Guardian® RT CGM System.

Or you can buy the MiniMed Paradigm 522/722 insulin pump and use it without the glucose monitoring system. Later, if you decide to try continuous monitoring, you can purchase the REAL-Time Continuous Glucose Monitoring Kit, designed to be used with those pumps. The monitoring kit should be available this summer.

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For Medtronic's press release:
Medtronic Receives FDA Approval for World's First Insulin Pump with Real-Time Continuous Glucose Monitoring

Product Recall - Insulin Pump Adapter

On July 29, Disetronic Medical Systems recalled its D-Tron adapter - for use with the D-Tron and D-TronPlus insulin pumps, and the Accu-Chek D-TronPlus insulin pump.
(A DTronPlus insulin pump is shown. The clear plastic adapter can be seen attached to the right of the pump.)

According to Disetronic:

"Use of the recalled adapter may result in the over delivery of insulin of up to 1.8 units of insulin." This "may pose a potentially life-threatening situation to children using the pump."

Overdelivery of insulin can result in hypoglycemia or low blood glucose. Anyone who requires a small amount of daily insulin or who is insulin sensitive and uses this adapter may be at risk for this condition.

Disetronic has manufactured new adapters. In the meantime, they recommend you inspect your adapter package before use. The affected adapter is marked as Part # REF 3000803. Their website has posted the old, recalled package label (left) and their new package label (right):


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For information regarding replacement of affected D-TRON adapters:
Contact the Disetronic Pump User Support Group at 1-800-688-4578.

For Disetronic's recall notice:
URGENT PRODUCT RECALL: Potential Life-Threatening Situation to Children Using the Pump

For the FDA's press release on the recall:
Disetronic Medical Systems, Inc. Announces a Voluntary Recall of the D-TRON Adapters, Used With the D-TRONplus Insulin Pump