Eager to hasten adoption of its second-to-market STS continuous glucose monitoring system, DexCom plans to embark any day on a nationwide launch of the just-approved device.

"It is an aggressive schedule," CEO Andrew Rasdal acknowledged. Finalizing the labeling to match FDA's final approval order is a "pretty extensive" exercise, he explained.

But once the packages are complete, "we're pretty much turning the sales representatives loose," he said. The company had started to assemble product components in anticipation of approval and has readied an initial launch quantity of the durable and sensor components of the STS system, he noted.

Shares of DexCom rose $1.79, or 9%, to $21.60 in premarket activity on March 27 - the day the PMA approval was announced - surpassing the company's 52-week high of $20.91 from earlier this month.

DexCom's full scale roll-out marks a different strategy than that recently taken by Medtronic, which initiated a more limited launch of Guardian RT , the first continuous glucose monitor on the U.S. market, in September (¹ Also see "Medtronic’s Guardian “Real-Time” Glucose Monitor Receives FDA Approval" - Medtech Insight, 15 August, 2005., p. 3).

The device giant is offering its product only in select cities to carefully build a case for securing reimbursement based on the experiences of early adopters. Currently, there is no established coverage, coding or payment for this technology.

Medtronic also is using the limited launch to assess the best approaches for training physicians and patients in advance of making the product more widely available.

But Dexcom is operating on the philosophy that broader geographic distribution of the device in the short term will further long-term adoption and reimbursement goals. "Making [the device] widely available...I think will help the cause," Rasdal said. "Payors can choose to ignore it if there is just a smattering of people within their own plans that are requesting" the product, he said.

DexCom has 15 sales representatives positioned to begin selling the STS immediately. Rasdal noted that the company expects to add another 5-15 reps within the next two weeks.

Medtronic is not the only competitor Dexcom is likely to have to contend with in the near future. Both Abbott ( Freestyle Navigator ) and Johnson & Johnson ( GlucoWatch G3 ) expect to gain FDA approval for continuous monitoring systems sometime this year.

Like Medtronic's device, the STS system measures glucose concentrations in the interstitial fluid between tissue cells on a minute-by-minute basis using a small, disposable sensor inserted under the skin. The results are wirelessly transmitted to a hand-held device that alerts diabetic patients to dangerously high or low glucose levels - information that can help them make insulin treatment decisions.

The sensors need to be replaced every three days; however, DexCom plans to file a PMA supplement for a seven-day version of the device after it conducts a clinical trial.

In addition to providing real-time glucose readings, DexCom's device also relays glucose trends to tell patients the direction and rate of their blood sugar changes to allow them to continually adjust their medication, diet and exercise to prevent high or low glucose levels. Medtronic says its second-generation product, which it expects to receive approval for by year-end, will incorporate the trend arrow feature to facilitate predictive modeling for patients.

Self-administered finger-stick tests remain the standard approach for diabetics to monitor glucose levels, but continuous monitoring systems are viewed in the clinical community as a step toward more effective, less invasive diabetes care.

The labeling for STS and Guardian RT requires finger stick tests to confirm results. At this point, the products are only meant as a tool to help the patient decide when a finger stick is needed. But Medtronic and Dexcom are both seeking labeling to support the replacement of finger sticks with continuous monitors.

Removing the finger stick step from the process is vital to achieving what clinicians consider a crucial long-term goal for improving diabetes management - an integrated system, in which a continuous glucose monitor can communicate with an insulin pump for automated treatment adjustments (² Also see "“Smart” Software Emerging As Key To Artificial Pancreas For Diabetes Care" - Medtech Insight, 20 March, 2006., p. 14).

Dexcom Moves Quickly To Tango With Medtronic In Next-Gen Glucose Testing

More from Archive

More from Medtech Insight