Artificial Pancreas System Better Controls Blood Glucose Levels than Current Technology
Study based at the Icahn School of Medicine at Mount Sinai and other centers finds new system has safety, efficacy benefits for people with type 1 diabetes
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
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.