A new artificial pancreas system that uses advanced control algorithms to automatically monitor and regulate blood glucose levels was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes, according to a multicenter randomized clinical trial based partly at the Icahn School of Medicine at Mount Sinai.
The study showed that the system improved participants' blood glucose control throughout the day and overnight. Overnight glucose control 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 was published October 16th in the New England Journal of Medicine.
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 the Icahn School of Medicine at Mount Sinai. 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 trial has been an important step forward in care for people with type 1 diabetes," said Carol Levy, MD, CDE, Clinical Director of the Mount Sinai Diabetes Center and the lead investigator at the Icahn School of Medicine at Mount Sinai.
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 in which their blood glucose levels remained within the target range of 70 to 180 mg/dL by an average of 2.6 hours per day, 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.
The Control-IQ technology was derived from a system originally developed at the University of Virginia, Charlottesville. 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.
"This system has some unique features to help patients achieve target glucose levels while reducing the risk of hypoglycemia. It has been an exciting study both for patients and the research team," said Dr. Levy. "By making management of type 1 diabetes easier and more precise by using artificial pancreas technology, the potential is tremendous to reduce the daily burden of this disease and improve long-term outcomes for our patients."
The study was primarily funded through the National Institute of Diabetes and Digestive and Kidney Diseases 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 the Mount Sinai Health System
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest integrated delivery system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Gynecology, Nephrology, Neurology/Neurosurgery, and Orthopedics in the 2019-2020 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology, Mount Sinai St. Lukes and Mount Sinai West are ranked 23rd nationally for Nephrology and 25th for Diabetes/Endocrinology, and Mount Sinai South Nassau is ranked 35th nationally for Urology. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and Mount Sinai South Nassau are ranked regionally.
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New England Journal of Medicine