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Medtronic touts data in support of FDA approval of the latest MiniMed glucose monitor

Medtronic presented data in support of FDA approval of its MiniMed 640G glucose monitor and pump at the ongoing annual meeting of the American Diabetes Association in Boston.


A European user evaluation study of 40 adult and pediatric patients found that the device automatically suspended insulin delivery 2,402 times.

"Severe hypoglycemia can have devastating effects on people with diabetes and even milder episodes can really impair quality of life," said lead investigator Dr. Pratik Choudhary, of King's College London in a statement.

"The more we can do to minimize the impact of ypoglycemia, the better we can make lives of people with diabetes. That is why patients in our user evaluation really loved MiniMed 640G with SmartGuard technology, because it effectively and unobtrusively reduced hypoglycemia."

The study was conducted prior to the international launch of the 640G, which remains investigational in the U.S., where a large multi-center pivotal trial is underway.
Meanwhile, the industry bigwig announced the launch of another pivotal trial of its Hybrid Closed Loop system, which is supposed to continuously control glucose levels with less input from patients.

It is the first trial of closed loop technology conducted the U.S., and the key step to securing FDA and international approval of the company's next-gen pump platform and sensor, according to a release.

"Insulin pumps and continuous glucose monitoring systems have greatly improved the ability for people with diabetes to achieve better glucose control and live longer, healthier lives," said Dr. Satish Garg, director of the adult diabetes program at the University of Colorado's Barbara Davis Center for Childhood Diabetes, one of the sites of the pivotal trial.

"However, even with these systems, patients must make hundreds of decisions each day. Simplifying this self-management with a more automated Hybrid Closed Loop system would have a very meaningful impact on these patients' lives."

In addition, diabetes specialist Valeritas, maker of the wearable V-Go Disposable Insulin Delivery Device presented two posters in support of the technology. The company said switching patients to V-Go lowered A1C levels, including by more than 3%. It also said that the V-Go reduces insulin levels by as much as 40% compared to traditional therapy.

The device is indicated for continuous subcutaneous infusion of fast-acting insulin and on-demand bolus dosing.

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