Artificial pancreas draft guidance could hurt Medtronic, others

FDA, industry and diabetes advocates may be heading for a clash over regulators' draft guidance for investigators and manufacturers on the development of artificial pancreas devices.

The Los Angeles Times' Eryn Brown explains that the combination insulin pump/continuous glucose monitor would be like an actual pancreas in that it would tightly control blood sugar levels through the glucose monitor. A computer connected to it would automatically deliver the right dose of insulin into the body through a pump. Such an advance could offer a breakthrough for patients suffering from Type 1 diabetes by helping them monitor and regulate blood sugar around the clock.

But as Reuters reporter Julie Steenhuysen notes in a separate story, diabetes advocates and some in the industry fear that regulators' proposed guidelines released Dec. 1 will hamper development of a viable artificial pancreas system. The proposed guidelines on how clinical trials can be conducted, and how far companies will have to go to prove to regulators that the devices are safe and effective, could delay bringing an artificial pancreas to the U.S. market for months or years, they argue.

Until now, U.S. researchers have had to seek international research partners to test their systems outside of the clinic to determine if they work. Domestically, regulators have only allowed carefully supervised hospital studies so far, Reuters notes, adding that some regulators thought approvals for U.S. clinical testing were taking too long.

Corporations like Medtronic and academics including a team at Boston University are developing variations of an artificial pancreas system, according to Reuters, though both say it will take some time to bring one to market.

The FDA, which will be seeking public comment on the draft guidance in the coming weeks, says its goal is to improve how artificial pancreas systems are studied and approved. The agency said in a statement that the goal of the guidance is to give manufacturers "maximum flexibility" as they seek to bring the device to patients. One positive sign: FDA officials suggest using three phases of clinical trials for the devices so they can be moved "to an outpatient setting as quickly as possible."

- see the Reuters story
- here's the Los Angles Times piece
- check out the FDA release
- here's the FDA draft guidance