An artificial pancreas, a device that automatically regulates insulin dosage for Type 1 diabetes patients based on real-time glucose data, may be a reality soon. Medtronic ($MDT) is nearing final data for a pivotal trial of its Hybrid Closed Loop System. It reportedly expects to submit to FDA for approval by the end of June, with an anticipated launch by April 2017.
The 127-patient pivotal trial is slated to have final data on its primary outcome in May; the study just started last June. The 10-site study is slated then to expand to more than 1,000 Type 1 diabetes patients, a report in the local Colorado paper the Aurora Sentinel said.
The story came after a recent visit by FDA Commissioner Dr. Robert Califf and Colorado Senator Michael Bennet to one of the pivotal study sites, the Barbara Davis Center for Diabetes on the Anschutz Campus in Aurora, CO.
Support for the development of the artificial pancreas has been an ongoing issue for Bennet, who has been in discussions with the FDA since 2011 on the topic. The FDA released guidance on an approval process for artificial pancreas devices in 2012 that the agency then finalized in 2014.
"We're making great progress and I think these are going to continue to help people," Dr. David Maahs, a principal researcher in several ongoing artificial pancreas trials told the Sentinel. "They're gradually going to get better and better. Like with cell phones, you went from having a brick phone, to a flip phone, to an iPhone one. I wish it were quicker, but that's how technology works."
The Medtronic pivotal trial is for its MMT-670G insulin pump in conjunction with its closed loop algorithm. There is no statistically powered primary endpoint in the pivotal study, rather there is a primary outcome measure that is a descriptive analysis of reduction in A1C. Abbott's ($ABT) hand-held diagnostic analyzer, i-Stat, is being used for blood glucose value reference validation.
The secondary outcome is the event rate for severe hypoglycemia at one year, this is also not a statistically powered endpoint.
"After years of research and development, the critical components of a closed loop system are here," said Medtronic Diabetes CMO and VP of global medical, clinical & health affairs Dr. Francine Kaufman in a statement at the pivotal trial start. "We are thrilled to be partnering with the world's leading investigators to do the clinical work to bring this technology to market so that it can help people with diabetes enjoy even greater freedom and better health."