Study based at Sansum Diabetes Research Institute and other centers shows safety, efficacy benefits for people with type 1 diabetes

A multicenter randomized clinical trial evaluating 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, based partly at Sansum Diabetes Research Institute, was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.

The system, called “Control-IQ”, 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 to dangerously low levels when a person is asleep. The research is published in the New England Journal of Medicine.

“Real-world results from use of the Control-IQ system over six months show it improved glycemic control and reduced the burden of care for people with type 1 diabetes and their caregivers. These were key goals of our study,” said Jordan E. Pinsker, MD, Director of Artificial Pancreas Technology at Sansum Diabetes Research Institute and one of the principal investigators of the study. “The improvements in glycemic control were consistent across patients starting with a wide range of hemoglobin A1c (5.4-10.6%) and across all ages (14-71 years), including participants who were previously on multiple daily injections (MDI),” said Dr. Pinsker.

The artificial pancreas, also known as closed-loop control, is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers the hormone insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with separate delivery of insulin by multiple daily injections or a pump.

The International Diabetes Closed-Loop (iDCL) Study involves five separate artificial pancreas clinical protocols implemented by 10 research centers, including Sansum Diabetes Research Institute. 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.

This 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 (SAP) 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.

The researchers found that users of the artificial pancreas system significantly increased 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 beginning the trial, while the time in range in the SAP group remained unchanged over six months. Artificial pancreas users also showed 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. “All 168 participants completed the study,” said Dr. Pinsker. “This was a testament to very high patient satisfaction with the closed-loop system.”

The study was funded through NIDDK grant UC4DK108483. Tandem Diabetes Care provided the experimental closed-loop systems, supplies, and technical expertise with device issues. The University of Virginia Strategic Investment Fund Project #88 provided institutional and regulatory support.

About Sansum Diabetes Research Institute:
Sansum Diabetes Research Institute (SDRI) has been on the cutting edge of diabetes research, education, and clinical care since our founding in 1944 by Dr. William Sansum, the first U.S. physician to manufacture and administer insulin in the treatment of diabetes. With an established world class reputation for innovation in the field of type 1 diabetes including the Artificial Pancreas system and diabetes in pregnancy, SDRI is broadening its area of expertise to address a range of issues in type 2 diabetes in an effort to address this growing epidemic.