The National Institutes of Health said this week that it is funding 4 projects dedicated to testing fully automated artificial pancreas devices in patients with Type I diabetes.
The race to develop an artificial pancreas met a milestone last year, after the FDA approved Medtronic’s (NYSE:MDT) hybrid model of an artificial pancreas – the 1st of its kind to win global clearance.
Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin.
Although the device automatically adjusts insulin levels, it requires that the patient manually enter all carboydrates consumed and approve bolus correction recommendations.
The 4 pivotal trials funded by the NIH will collect data for fully automated artificial pancreas devices, in the hopes of eventually gaining regulatory approval from the FDA.
“These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it,” Dr. Guillermo Arreaza-Rubín, director of the National Institute of Diabetes and Digestive and Kidney Diseases’ diabetes technology program, said in prepared remarks. “Results from these studies could change and save lives.”
The 4 projects, slated to begin in 2017 or 2018, will include larger study groups for longer periods of time compared to previous work, according to the NIH. The study participants will live at home and monitor themselves, while the study staff will remotely monitoring the group, the NIH said.
One of the trials plans to test an automated insulin delivery system in 240 people ages 14 and up with Type I diabetes for 6 months. A 2nd trial said it will test an artificial pancreas in 130 adolescents for a full year.
The 3rd research group will compare Medtronic’s FDA-approved hybrid artificial pancreas to a next-generation system in 100 kids for 3 months.
The 4th trial, which is slated to begin in mid-2018, will enroll 312 people ages 18 and older for 6 months. The study plans to evaluate a bihormonal bionic pancreas system, with a dual-chamber pump to deliver insulin and glucagon.
The research teams will evaluate the systems for safety, efficacy, user-friendliness, physical and emotional health of the study participants and cost.
“Managing Type 1 diabetes currently requires a constant juggling act between checking blood glucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” NIH official Dr. Andrew Bremer said. “Unifying the management of Type 1 diabetes into a single, integrated system could lift so much of that burden.”