FDA OKs Insulin Pump Plus Glucose Monitor System

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March 17, 2010 – The FDA has approved Medtronic’s new diabetes management system, which takes patients one step closer to theelusive goal of an artificial pancreas.

The new MiniMed Paradigm REAL-Time Revel System does not entirely close theloop between glucose monitoring and insulin treatment. Patients still have toconfirm 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 invery low increments — as low as 1/40 of a unit per hour — a usefulfeature for children or other people who are sensitive to insulin.

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

In a recent Medtronic study, the new system improved detection oflow-blood-sugar events by nearly 36%, while only very slightly decreasing (by4%) detection of high-blood-sugar events.

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

“Advances such as predictive alerts and smaller [insulin] delivery rates canhelp physicians and patients customize therapy to meet individual needs. Thisultimately 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 1diabetes patients with commercial insurance coverage who have a medicalindication for the device will be reimbursed. A Medtronic spokesperson tellsWebMD that the out-of-pocket costs for such patients is between $500 and$1,200.

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