First Outpatient Pilot Studies of a Prototype Artificial Pancreas

For the first time ever, patients with T1D were able to control their diabetes using an artificial pancreas system in a real-life setting. In parallel experiments performed at Montpellier University Hospital and at the Universities of Padova and Pavia two patients with T1D attained near-normal glucose levels after spending one night outside of a hospital while their diabetes was automatically managed by a prototype artificial pancreas system. The patients were able to eat a meal at a restaurant and spend one night at a hotel while using the device. These studies represent the first outpatient pilot trials using an approach developed by investigators in the JDRF Artificial Pancreas consortium including teams from Montpellier University Hospital, the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA). Eight more patients enrolled in the trial will begin outpatient testing in Montpellier and in Padova and the investigators are currently seeking FDA approval to conduct similar pilot studies at the University of Virginia, USA. The research team used already-approved insulin pumps (OmniPod) and continuous glucose monitors (DexCom), which were controlled by a hand-held device created at the University of Virginia by a team led by Drs. Boris Kovatchev and Patrick Keith-Hynes and monitored by the investigators at all times to ensure safety. These pilot clinical studies are aimed at the stepwise deployment and testing of the hardware and software components leading to a pivotal trial of a system that will be run by a cell-phone-type device communicating with CGM sensors and insulin pumps and will be suitable for long-term use at home.

Reference:

The launch of this outpatient pilot study was the subject of an oral presentation by Drs. Boris Kovatchev and Claudio Cobelli at the 2011 Diabetes Technology Meeting in Burlingame CA.

Ramifications for Individuals with Type 1 Diabetes:

The launch of this first outpatient pilot represents a significant step in the development and delivery of a first generation artificial pancreas system designed to minimize both high and low blood sugar levels. An artificial pancreas device with this software would maintain blood sugar within a target range between, for example, 80 mg/dL and 180 mg/dL, by automatically increasing insulin delivery when it senses blood glucose going above the high end of the range, and slowing down or turning off insulin delivery when it senses blood glucose levels moving below the low end of the range. The wearer would still need to manually tell the pump to deliver insulin at times, such as around meals, and adjust insulin delivery rates based on activity, illness, and other variables.

JDRF Involvement:

JDRF funded this study with Dr. Kovatchev, who is a member of the JDRF Artificial Pancreas Consortium.