Eric Renard, MD, PhD
Early results from clinical trials in both children and adults show improved glucose control using an artificial pancreas system compared to conventional treatment.
During the Scientific Sessions symposium The Artificial Pancreas in 2019—First Reports of New, Large-Scale Trials and the Path Forward, which begins at 2:15 p.m. Sunday in N-Hall E (North, Exhibition Level), four researchers will share the latest findings and discuss the potential for regulatory approval of an artificial pancreas system in the near future.
“Our first three-month analysis showed there was benefit and safety to use the artificial pancreas 24/7,” said Eric Renard, MD, PhD, Professor of Endocrinology, Diabetes and Metabolism at Montpellier Medical School and Head of Endocrinology, Diabetes and Nutrition at Lapeyronie University Hospital in Montpellier, France. “Glucose control is better when you use the artificial pancreas all the time and there is no more hypoglycemia. We will discuss our latest results in San Francisco.”
Dr. Renard will present nine-month results from the study Multicenter Assessment of the Efficacy of Closed-Loop Insulin Therapy on the Control of Type 1 Diabetes in Prepubertal Children—Comparison between Nocturnal and 24-Hour Use During 18 Weeks of Home Use.
Sue A. Brown, MD, Associate Professor of Research and Medicine in Endocrinology and Metabolism at the University of Virginia Medical School, will present the latest findings from The International Diabetes Closed-Loop (iDCL) Trial—Clinical Acceptance of the Artificial Pancreas, which is being conducted in patients 14 and older.
Both trials involve the same artificial pancreas system using continuous glucose monitoring, insulin pump, and control algorithm, but the active comparators and time frames are different in the studies.
“This is not an investigational product,” Dr. Renard said. “It’s a product that is expected to be launched very quickly after approvals in both Europe and the U.S.”
Dr. Renard’s pediatric study compares continuous use of the artificial pancreas versus nighttime-only use with a pump and continuous glucose monitoring with no algorithm during the day. Dr. Renard will discuss findings from a planned nine-month interim analysis. The trial is scheduled to run 12 months.
“This is the longest experience of the artificial pancreas used in real life in children ages 6 to 13,” Dr. Renard said. “So far, the longest studies have been six months. We had great enthusiasm for recruitment and should be finished with the 12 months of comparison late this year or early in 2020.”
Dr. Brown’s presentation compares the same control-to-range closed-loop artificial pancreas to conventional treatment using continuous glucose monitoring and insulin pump in adolescents and adults over three months.
The impact of moving from conventional treatment for type 1 diabetes to an artificial pancreas system is more profound than researchers expected, Dr. Renard said. They hoped to see significant improvements in patients’ glycemic control and did.
“What’s not shown by the numbers is the major benefit we found for the families,” he said, adding that many parents of children with type 1 diabetes don’t sleep through the night—there’s always at least one parent awake keeping watch.
“From the very start of this 24/7 protocol, the family is completely transformed because both parents can now sleep all night, every night,” Dr. Renard said. “Some mothers started to work where they could not before because they did not sleep nights.”
Children with diabetes also appreciate the change in their parents’ sleep patterns, Dr. Renard added.
“All of the children are happy to wake up with normal glucose levels when they go off to school and know that their glucose will be under control all day. And many of them say they are very happy with this new treatment because my mother can sleep now. It’s quite encouraging to see how much life can change beyond just glucose control.”
