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 was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.
The study showed 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 to dangerously low levels when a person is asleep. The research is published 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.
According to Guillermo Arreaza-Rubín, M.D., director of NIDDK’s Diabetes Technology Program and project scientist for the study, “Earlier technologies have made the management of type 1 diabetes easier, and this research shows that this artificial pancreas system has the potential to improve the health of people living with type 1 diabetes, while also potentially lifting much of the burden of care from those with the disease and their caregivers.”
This iDCL protocol enrolled 168 participants ages 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 (DKA) occurred in one participant in the artificial pancreas group due to a problem with equipment that delivers insulin from the pump.
Boris Kovatchev, Ph.D, and director of the UVA Center for Diabetes Technology was co-lead author of the study with colleagues Sue A. Brown, M.D., of UVA and Roy Beck, M.D., Ph.D., from the Jaeb Center for Health Research, Tampa, Florida, which was the coordinating center for the study.
“This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods,” said Kovatchev. “In particular, there is a special safety module dedicated to prevention of hypoglycemia, and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.”
“Artificial pancreas technology has tremendous potential to improve the day-to-day lives of people with type 1 diabetes,” said NIDDK Director Griffin P. Rodgers, M.D. “By making management of type 1 diabetes easier and more precise, this technology could reduce the daily burden of this disease, while also potentially reducing diabetes complications including eye, nerve, and kidney diseases.”
For the full article, please visit the National Institutes of Health at https://www.nih.gov/news-events/news-releases/artificial-pancreas-system-better-controls-blood-glucose-levels-current-technology