Medical Device Daily

Nearly three months ago Medtronic (Minneapolis) presented data at the 69th annual American Diabetes Association (ADA; Alexandria, Vriginia) touting the development of a new platform that could automatically monitor and deliver insulin to patients based on their physiological reactions to environment and activity (Medical Device Daily, June 10, 2009). The med-tech giant said that the release of such a platform was on the horizon.

Now, those claims are made true, as the company reported the global launch of the Paradigm Veo, at this year's annual meeting of the International Society for Pediatric and Adolescent Diabetes (Berlin) in Ljubljana, Slovenia. With this announcement the device is available in more than 50 countries outside of the U.S.

"We're currently in dialogue with the FDA to see what kind of data and what kind of information they need for the PMA approval process," Deanne McLaughlin, a spokeswoman for Medtronic told Medical Device Daily. "So at this time we're not really predicting a launch in the U.S."

She was quick to add however, that the approval in Europe could give the company some much needed momentum in its talks with the FDA.

"People are seeing the device in Europe and are asking when is it going to be available here," she said.

While not completely a closed loop system, the device has a Low Glucose Suspend (LGS) feature that regularly checks a patient's glucose levels 24-hours a day and automatically suspends insulin delivery when glucose levels become too low, protecting against the risk of hypoglycemia (low blood sugar) even when a person is asleep and unable to react.

It includes an insulin pump with a continuous glucose monitoring system, provided by means of a separate sensor and transmitter. According to the company the patient uses readings from the monitor in conjunction with finger stick blood glucose measurements to get a reading. Based on the result, the patient then programs the insulin pump to deliver an appropriate amount of insulin.

But if the data from the sensors show that the patient's glucose levels have dropped below the desired level, the device alarms alert the patient.

If these alarms continue to be ignored, the insulin pump suspends insulin delivery for up to two hours.

Plans call for the company to eventually develop a closed loop system, a system that completely mimics the insulin delivery of a normal pancreas using technology that automatically responds to and treats glucose fluctuations in patients with diabetes.

The company took steps toward realizing this goal with the purchase of virtually all glucose monitoring assets from Precisense (Horsholm, Denmark) (MDD, June 4, 2009). Financial terms of the purchase were not disclosed.

"[The technology procured from] Precisense will start to be baked into our R&D," McLaughlin said. "It's being used internally now and it will take a while for it to emerge."

But Medtronic isn't the only company or entity out there trying to develop a close-loop system. University of California Santa Barbara and Sansum Diabetes Research Institute (both Santa Barbara, California) scientists have demonstrated for the first time that an automated artificial pancreas system (APS) can safely and effectively maintain desired blood glucose levels in patients with Type 1 diabetes.

To achieve this end, researchers tested an automated insulin delivery system comprising Insulet's (Bedford, Massachusetts) OmniPod System and DexCom's (San Diego) STS7 continuous glucose monitor, linked and controlled through UCSB's artificial pancreas software.

The software's insulin delivery algorithm, optimized for each patient, includes a unique safety feature, based on clinical parameters, which prevents insulin-induced low blood glucose levels. Researchers say that more patients need to be tested before their system can be called a true" artificial pancreas.

So there's still quite a bit of ground to cover before catching up with Medtronic, which so far has had a stellar year in sales with its diabetes products.

According to a recent report in MedCity News, Diabetes products made up more than $1.1 billion in revenue in Medtronic's 2009 fiscal year. The report also said that the company's diabetes sales grew to $295 million, in 1Q10 which was 10% more than the previous first quarter thanks to insulin pump and continuous glucose-monitoring product sales.

"The Paradigm Veo is the biggest step thus far in our commitment to closing the loop on diabetes management," says Chris O'Connell, president of the Diabetes business and senior vice president at Medtronic. "While not a cure for diabetes, we believe this automatic feature offers added protection, greater confidence and may lower the risk of injury associated with hypoglycemic events. Equally important, it will give patients and family members more peace of mind."

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com