Medtronic Brings Realization of Artificial Pancreas One Step Closer

Late last year, I reported that many experts would be willing to place bets on the efficacy of an artificial pancreas to treat diabetes...if only FDA would permit it. Then, FDA published draft guidance on the artificial pancreas, eliciting guarded optimism among industry experts that the FDA's move could finally represent the first step toward making this technology available in the United States.

Now, Medtronic claims that is has taken the next step in the direction of developing an artificial pancreas, publishing results of the company's in-clinic Automation to Simulate Pancreatic Insulin Response (Aspire) study online and in the March edition of Diabetes Technology & Therapeutics. The study met its efficacy endpoints, demonstrating that compared with conventional pump therapy, patients using the company's MiniMed Paradigm integrated insulin pump and continuous glucose monitor experienced a 19% reduction in the time spent below the low-glucose threshold. The pump system's low-glucose suspend (LGS) automation capability automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value. Interestingly, while it is commercially available outside the United States, the Paradigm system is limited to investigational use in the United States.

The study showed that diabetes patients using the Medtronic's system spent less time below 70 mg/dL, the low-glucose value at which insulin was suspended. And the study group's average drop in blood glucose values remained higher than that experienced by patients using conventional insulin pumps. In addition, the low-glucose suspension did not result in rebound hyperglycemia.

"Until now we have never had a therapy designed to automatically intervene when blood glucose becomes dangerously low, which is the greatest fear and biggest challenge in achieving better glucose control in patients with diabetes," remarks Satish K. Garg, professor of medicine and pediatrics at the Barbara Davis Center for Childhood Diabetes and lead author of the study. "Therapies that help people with diabetes stay within normal range are important and we look forward to continue advancements in this area. It makes sense to stop insulin delivery when a low glucose threshold is met and that is how LGS is designed."

Beyond the sheer newsworthiness of Medtronic's announcement, the creation of an artificial pancreas should open new avenues for designers and developers of medical devices and their components suppliers to refine and perfect the technology--both during the development phase and after such a device hits the market. Many medical device manufacturing experts will be required to develop such a device, including sensor specialists, electronics experts, pump providers, and software developers. In that light, Medtronic's announcement that its study satisfies a variety of efficacy endpoints should be greeted positively not only by diabetes patients but also by medical device manufacturing companies. --Bob Michaels