A multicenter clinical trial has found that a new artificial pancreas system—which automatically monitors and regulates blood glucose levels—has found that the new system was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes. The trial was conducted partly at the University of Colorado Anschutz Medical Campus and was primarily funded by the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK), part of the National Institutes of Health.
Known as the International Diabetes Closed-Loop (iDCL) study, it involved five separate artificial pancreas clinical protocols implemented by 10 research centers including CU Anschutz. This six-month study was the third phase in the series of trials. It was conducted with participants living their usual day-to-day lives, so the researchers could best understand how the system works in typical daily routines.
The iDCL protocol enrolled 168 participants age 14 or older with type 1 diabetes. They were randomly assigned to use either the artificial pancreas system called Control-IQ or sensor augmented pump (SA)) therapy with a CGM and insulin pump that did not automatically adjust insulin throughout the day. Participants had contact with study staff every two to four weeks to download and review device data. No remote monitoring of the systems was done so that the study would reflect real-world use.
What did the Study Reveal?
That the artificial pancreas (aka closed-loop control) is an all-in-one diabetes management system that tracks blood glucose levels using a continuous glucose monitoring (GCM) and automatically delivers the hormone insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or (GCM) with separate delivery of insulin by multiple daily injections or a pump.
The study evidenced that the system improved participants’ blood glucose control throughout the day and overnight. The latter is a common but serious challenge for children and adults with type 1 diabetes, since blood glucose can drop dangerously low levels when a person sleeps. The recent results were published in the New England Journal of Medicine.
The team found that the artificial pancreas system significantly reduced the amount of time with their blood glucose levels in the target range of 70 to 180 mg/dL by an average of 2.6 hours per day since the beginning of the trial, while the time in range in the SAP ground remained unchanged over six months. Artificial pancreas users also evidenced improvements in time spent with high and low blood glucose, hemoglobin A1c and other measurements related to diabetes control compared to the SAP group.
High adherence to device use in both groups and 100% participant retention were important strengths of the study. During the study, no severe hypoglycemia events occurred in either group. Diabetic ketoacidosis occurred in one participant in the artificial pancreas group due to a problem with equipment that delivers insulin from the pump.
The Investigational Product
The Control-IQ technology was derived from a system originally developed at the University of Virginia, Charlottesville, (UVA) by a team led by Boris Kovatchev, Ph.D., director of the UVA Center for Diabetes Technology with funding support from NIDDK. In this system, the insulin pump is programmed with advanced control algorithms based on a mathematical model that uses the person’s glucose monitoring information to automatically adjust the insulin dose. Tandem Diabetes Care has submitted the results to the U.S. Food and Drug Administration for approval to market the Control-IQ system.
University of Virginia is the lead investigative site andUniversity of Colorado Anschutz Medical Campus and several other research centers were involved in this study. Boris Kovatchev was the co-lead for the study with colleagues Sue A. Brown, MD of UVA and Roy Beck, MD, PhD, from the Jaeb Center for Health Research, Tampa, Florida, which was the coordinating center for the study.
Who is Tandem Diabetes Care?
Tandem Diabetes Care is a public U.S. medical device maker based in San Diego, Ca. The company develops medical technologies for the treatment of diabetes and specialty insulin infusion therapy. With approximately $281 million in revenues, the company stock at present trades at $61.13 per share for a healthy market capitalization of $3.7 billion. The company has approximately $131 million cash.
Call to Action: This clinical trial included interesting real-world attributes for other sponsors to consider. We will track the commercialization process for the Control-IQ technology.