Medtronic Diabetes (Northridge, California) has received FDA approval of the MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System, which its parent company, Medtronic (Minneapolis), said is the "first time in the history of diabetes management" that an insulin pump is integrated with glucose monitoring, though that integration still requires some patient action.

The new technology, the MiniMed Paradigm Real-Time System, "will help patients take immediate corrective or preventive action" toward maintaining normal glucose levels, ultimately helping patients to avoid complications down the road by maintaining tight glucose control, Medtronic said.

Steve Sabicer, senior manager, public relations, of Medtronic Diabetes, told Medical Device Daily that he expects the system to "have a huge impact on the diabetes industry. It's the only system out there that can do this, and I think it's going to be a significant event for Medtronic, as well."

The Paradigm Real-Time System is made up of two components: a Real-Time Continuous Glucose Monitoring (CGM) System and a MiniMed Paradigm insulin pump. The Real-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays up to 288 readings a day, or "nearly 100 times more information than three daily fingersticks."

The "integration" described by Medtronic is the ability of the pump to automatically deliver the correct amount of insulin, via special algorithms, as indicated by the sensor. The patient, however, still has to take action - pushing a button on the pump to verify the correct dosage being delivered.

This is accomplished with a Bolus Wizard calculator on the pump - essentially making it "smart" - to manage the often complex math for patients. The pump is worn outside the body on a belt, Sabicer said.

The system also does not eliminate the need for fingersticks.

"Currently the FDA labeling requires a fingerstick for therapy, and we require a fingerstick for calibration [every 12 hours]; however, we will . . . as the data presents itself, look to pursue labeling that doesn't require a fingerstick," Sabicer said.

Medtronic said the closer integration of insulin pump with Real-Time CGM is a "major step" toward the development of a closed-loop insulin delivery system that will mimic some functions of the human pancreas, meaning it will require no fingersticks or patient action to operate.

Last August, Medtronic Diabetes reported the PMA-supplement approval of its Guardian RT continuous glucose monitoring system, which was a major step toward this next-generation system combining glucose monitoring with the ability to administer therapy (Medical Device Daily, Aug. 12, 2005).

"The approval of the MiniMed Paradigm Real-Time System opens the door to the next generation of diabetes management," said Robert Guezuraga, president of Medtronic Diabetes, in a statement. "As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives."

The continuous glucose sensor of the system is a sensor inserted under the skin using the Sen-Serter, a device that patients or their caregivers can use to insert the sensor. The sensor measures glucose in the interstitial fluid found between the body's cells. It is typically discarded and replaced after three days of use.

Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the insulin pump, which displays the glucose value, three-hour and 24-hour trend graphs. It also includes arrows to indicate how quickly glucose is moving up or down.

An alarm alerts patients when glucose levels become too high or too low so that the "smart" pump can be activated.

Sabicer told MDD that the pump will cost between $800 and $1,500, depending on insurance, while the CGM starter kit will cost $999.

In a report on the announcement of the Paradigm Real-Time pump, Larry Biegelsen, senior analyst, medical devices, for Prudential Equity Group (New York), said that FDA approval of the system "comes about six months ahead of our expectations."

"This is the first device to integrate an insulin pump with continuous glucose monitoring technology," Biegelsen wrote. "We believe that continuous glucose monitoring devices are likely to be a game-changing technology for the treatment of diabetes, because CGM devices have the potential to replace inconvenient fingerstick tests and provide tight glucose control, which may lead to better outcomes and reduced healthcare costs."

Biegelsen wrote that Medtronic is currently the market leader in the $800 million insulin pump market.

"The Paradigm Real-Time gives [Medtronic] access to the $5 billion glucose monitoring market, a major new opportunity for the company," he wrote.

However, Biegelsen said Prudential expects "the uptake of the [device] to initially be slow as it will take time for [Medtronic] to convince payers to reimburse the device and sensors."

Prudential estimates the CGM market will exceed $1 billion in total sales. The report forecast Medtronic diabetes sales of $739 million in FY06.

Late last month, DexCom (San Diego) was FDA-approved for its STS Continuous Glucose Monitoring System, a sensing device inserted beneath the skin for a three-day period and signaling the user when additional insulin must be delivered. That approval was hailed by the Juvenile Diabetes Research Foundation (New York) as one of the steps important for reaching the ultimate goal of a true artificial pancreas (MDD, April 4, 2006).