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FDA OKs Insulin Pump Plus Glucose Monitor System

The FDA has approved Medtronic’s new diabetes management system, which takes patients one step closer to the elusive goal of an artificial pancreas.

The new MiniMed Paradigm REAL-Time Revel System does not entirely close the loop between glucose monitoring and insulin treatment. Patients still have to confirm the device’s warning with a finger-stick blood sugar measurement.

But the monitor predicts dangerously low or high blood sugar levels. And the pump allows patients to administer insulin in very low increments — as low as 1/40 of a unit per hour — a useful feature for children or other people who are sensitive to insulin.

Moreover, the system comes with a device that plugs into a computer’s USB port and wirelessly uploads information from the insulin pump and glucose monitor. Web-based software helps patients keep close track of their blood sugar control.

In a recent Medtronic study, the new system improved detection of low-blood-sugar events by nearly 36%, while only very slightly decreasing (by 4%) detection of high-blood-sugar events.

In a Medtronic news release, William Tamborlane, MD, chief of pediatric endocrinology at Yale Medical School, says that linking an insulin pump to a continuous glucose monitor improves diabetes patients’ blood sugar control while reducing the risk of blood sugar crashes.

“Advances such as predictive alerts and smaller [insulin] delivery rates can help physicians and patients customize therapy to meet individual needs. This ultimately simplifies some of the complexity of daily diabetes management.”

Medtronic says the system is immediately available to patients.

The retail price of the system is $6,500, but Medtronic says some 90% of type 1 diabetes patients with commercial insurance coverage who have a medical indication for the device will be reimbursed. A Medtronic spokesperson tells WebMD that the out-of-pocket costs for such patients is between $500 and $1,200.

Source:  Medtronic website.

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