Artificial pancreas system is safe and can effectively control type 1 diabetes in children aged 6 and older: Study
Fewer than 1 in 5 children with type 1 diabetes can successfully keep their blood glucose in a healthy range with current treatment, which may have serious consequences on their long-term health and quality of life, say experts. Now, a clinical trial at four pediatric diabetes centers in the US has found that a new artificial pancreas system -- which automatically monitors and regulates blood glucose levels -- is safe and effective at managing blood glucose levels in children as young as age six with type 1 diabetes.
The analysis reveals that children using the artificial pancreas system had a 7% improvement in keeping blood glucose in range during the daytime, and a 26% improvement in nighttime control compared to the control group. According to the research team, nighttime control is of particular importance for people with type 1 diabetes, as severe, unchecked hypoglycemia (very low blood glucose levels) can lead to a seizure, coma, or even death.
“The study found that the artificial pancreas did a better job keeping the children’s blood glucose in the target range. The average amount of time in the target range during the day was 7 percentage points higher using the artificial pancreas, while nighttime control was 26 percentage points higher. The average amount of time overall, where participants’ blood-glucose levels were within the target range, was 11 percentage points higher than in the control group, which equals 2.6 more hours per day in range,” lead author Dr Marc D Breton, associate director for research, Center for Diabetes Technology at the University of Virginia (UVA), told MEA WorldWide (MEAWW).
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 insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.
The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. Results from the trial have been published in the New England Journal of Medicine (NEJM). The artificial pancreas technology used in this study, the Control-IQ system, has an insulin pump that is programmed with advanced control algorithms based on a mathematical model using the person’s glucose monitoring information to automatically adjust the insulin dose. This technology was derived from a system originally developed at the University of Virginia, Charlottesville, with funding support from NIDDK.
The four-month study was part of a series of trials conducted in the International Diabetes Closed-Loop (iDCL) study. Besides UVA, study sites included University of Colorado, Aurora; Stanford University School of Medicine, Palo Alto, California, and Yale University School of Medicine, New Haven, Connecticut. Jaeb Center for Health Research served as the data coordinating center. Based on data from the iDCL trials, Tandem Diabetes Care has received clearance from the US Food and Drug Administration (FDA) for use of the Control-IQ system in children as young as age six years.
“Data from this and other studies has prompted the FDA to approve the device for use by children ages 6 and older. We now strive to make this technology available for all patients older than 2 years old. Furthermore, we are developing and testing the next installments of artificial pancreas technology, building personalized, adaptable systems that can better manage meals and physical activities without any user inputs,” Dr Breton told MEAWW.
Between June 21, 2019, and August 30, 2019, the randomized clinical trial enrolled 101 children between ages 6 to 13 at the four sites. They were randomly assigned either to the experimental group (78 participants), which used the artificial pancreas system or to the control group (23 participants), which used a standard continuous glucose monitor and a separate insulin pump. Check-ins and data collection were conducted every other week for four months. “Study participants were instructed to continue about their daily lives so that the researchers could best understand how the system works in the typical routines of the children,” explains Dr Breton.
The results show that during the 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. A total of 16 adverse events, all classified as minor, occurred in the artificial pancreas group during the study, with most due to problems with the insulin pump equipment. Three events occurred in the control group. No cases of severe hypoglycemia or diabetic ketoacidosis, which is a complication caused by very high blood glucose levels, occurred during the study.
“The improvement in blood glucose control in this study was impressive, especially during the overnight hours, letting parents and caregivers sleep better at night knowing their kids are safer. Artificial pancreas technology can mean fewer times children and their families have to stop everything to take care of their diabetes. Instead, kids can focus on being kids,” emphasizes protocol chair Dr R Paul Wadwa, professor of pediatrics at the Barbara Davis Center for Childhood Diabetes, University of Colorado.
The iDCL study is one of four major research efforts funded by NIDDK through the special statutory funding program for type 1 diabetes to test and refine advanced artificial pancreas systems. The studies, with additional results forthcoming, are looking at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost, say authors.
“For decades, NIDDK has funded research and technology development to create a user-friendly automated device that could ease the constant burden of type 1 diabetes, from the finger sticks and insulin injections to the insulin dose calculations and constant monitoring while improving diabetes control outcomes and preventing both short- and long-term complications of the disease,” writes Dr Guillermo Arreaza-Rubín, director of NIDDK’s Diabetes Technology Program and project scientist for the study. He adds, “The artificial pancreas is a culmination of these years of effort, and it’s exciting to see how this technology may benefit children with type 1 diabetes and their families, and hopefully benefit everyone with diabetes in the future.”