MiniMed Jumps First FDA Hurdle with Continuous Glucose Monitor for Physicians’ Use

MiniMed’s continuous glucose monitor appears to have passed through the first phase of FDA approval. An advisory panel, which makes initial recommendations to the entire agency, voted unanimously to recommend approval to the entire FDA.

Only a physician will read glucose levels from this monitor. Patients do not get readings at home to adjust insulin doses. If approved, it will be the first device that measures interstitial fluid glucose rather than blood glucose. Interstitial fluid, found just below the skin, carries glucose to the cells, giving them energy to function.

If the product gets final approval, MiniMed’s plans are to sell the devices to physicians. If a doctor wants a more detailed picture of a patient’s glycemic control, then the patient can take it home. Once at home, the patient inserts a sensor into the abdomen, similar to an insulin pump infusion set. The sensor is connected by wire to a pager-sized monitor that can be attached to a belt or placed in a pocket.

Glucose levels will be measured every five minutes and stored in the monitor’s memory, for a total of 288 readings per day. Sensors last for three days, after which the patient can return the device to the physician, who downloads the information into a computer. From there the physician can get the details of the patient’s control throughout the day, including graphs and charts.

According to Alfred Mann, MiniMed’s chairman and CEO, physicians can use the sensor with patients who are having trouble with control, to determine solutions, or to see if the person is a good candidate for an insulin pump.

MiniMed stresses that FDA approval is not yet final. To get the latest update, call MiniMed’s information line at (800) 933-3322, ext. 4097.

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