Medical device maker Medtronic Inc. said Thursday that U.S. regulators had approved a system for diabetics that continually monitors blood-sugar levels and recommends insulin doses to control them.
The device, approved by the Food and Drug Administration, relays blood-glucose readings every five minutes from a sensor inserted under the skin to a pager-size pump, the Minneapolis-based company said. The pump displays current blood-sugar levels and shows on a chart the trend over the last three and 24 hours to help patients precisely adjust their insulin levels.
The system does not eliminate the need for insulin shots, but it takes Medtronic a step closer to developing a device to replace the pancreas, which produces insulin to convert blood sugar to energy, analysts said.
The company is working to persuade insurers to cover the $7,000 monitoring system, which would provide far more information than patients get from testing blood taken from their fingers three times daily.
"Having better control of your blood glucose ... is going to represent, ultimately, an important therapeutic advance," said Bruce Nudell, an analyst with Sanford C. Bernstein & Co.
Glucose monitoring and insulin shots prevent complications such as blindness, kidney disease and nerve damage in diabetes patients.
The Medtronic system would be used primarily by patients with Type 1 diabetes, which often occurs early in life when the insulin-producing cells of the pancreas are destroyed. As many as 1 million Americans have that form of the disease.
For now, Medtronic's system is more of an advance scientifically than financially, analysts said.
"Now, they need proof" that the system works better than older products in the $6-billion-a-year market for blood-sugar monitoring, Nudell said. "That's what will be needed to get insurers to pay extra for the sensor."
Medtronic shares fell $1.11 to $49.93.