Earlier-than-anticipated approval of its Paradigm real-time insulin pump and continuous glucose monitoring system again puts Medtronic one step ahead of the competition in moving toward "closed-loop" diabetes management, the company suggests.

The integrated Paradigm system, approved via PMA supplement on April 13, consists of a disposable glucose sensor inserted under the skin, a transmitter that relays glucose values via radio frequency and a "smart" insulin pump that receives the signal and delivers insulin "in a way that [approximates] the functioning of a human pancreas," according to Medtronic.

Because the system still requires confirmatory fingerstick testing and final authorization by the user before insulin is administered, it is considered an "open-loop" system.

Formerly, Medtronic had projected that therapy of this kind would be available in 2007 (¹ Also see "“Smart” Software Emerging As Key To Artificial Pancreas For Diabetes Care" - Medtech Insight, 20 March, 2006., p. 14). Now the company says it will begin shipping the system's continuous glucose monitoring component this summer. The pump is already available.

The company maintains that a closed-loop system - wherein information from the sensor is processed automatically to regulate insulin delivery - remains four to five years away.

Nonetheless, "this new [open-loop] technology will help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications," the firm says in an April 13 release announcing the approval.

With the sensor communicating glucose levels every five minutes, the pump is able to display up to 288 readings per day - nearly 100 times more information than three daily fingersticks, according to Medtronic.

In addition, the pump displays three-hour and 24-hour trend graphs, as well as arrows indicating how fast - and in which direction - glucose levels are moving, Medtronic says.

The pump's Bolus Wizard calculator provides recommended dosage levels based on current glucose levels, food intake and personalized information preset by the user.

In fact, the physical components for a closed-loop system are already in place, a Medtronic spokesperson observed in an April 13 interview.

The challenge now is improving the algorithms that drive the technology's predictive ability and adding inputs related to lifestyle activities and outlier events that can have an impact on glucose levels, he said.

Meanwhile, Medtronic will evaluate consumer data in an effort to gauge users' response to continuous glucose monitoring, which was first made available through the August 2005 approval of its Guardian RT system.

In a March 16 interview, Sethu Reddy, MD, chair of Cleveland Clinic's endocrinology department, suggested that concerns about the accuracy of the sensor component of monitoring technology have factored in the preservation of fingerstick testing.

The Medtronic rep suggested that as patients' comfort levels increase, the company will explore opportunities to optimize convenience by keeping fingerstick testing to a minimum.

Guardian, which interacts with a handheld monitor rather than a pump, has been rolled out on a limited basis to build a case for reimbursement and to cultivate an understanding of the best techniques for training users.

The next-generation version of Guardian could be available nationwide later this year, Medtronic says. Additionally, the firm will publish clinical data on Guardian's performance later this year to support its efforts toward securing coverage.

DexCom's STS continuous monitoring system, second to receive FDA's go-ahead, should launch nationally "any day," the company has said (² Also see "Dexcom Moves Quickly To Tango With Medtronic In Next-Gen Glucose Testing" - Medtech Insight, 3 April, 2006., p. 5).

Abbott and Johnson & Johnson have projected approvals in 2006 for their Freestyle Navigator and GlucoWatch G3 continuous glucose monitoring technology, respectively.

- Ryan Nelson

Medtronic Moves Closer To Closed-Loop Diabetes Care With Paradigm

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