Study results presented Sunday at the Scientific Sessions demonstrating the safety and efficacy of artificial pancreas systems for insulin delivery and glycemic control signal that this long-discussed technology is moving closer to approval and widespread use.
Sue A. Brown, MD, Associate Professor at the University of Virginia Health System, presented glycemic outcome results from a six-month, multicenter, randomized controlled trial (RCT) comparing a closed-loop control (CLC) system with sensor-augmented pump (SAP) therapy. Dr. Brown reported that the CLC system improved time-in-target range by 11 percent, reduced A1C by .33 percent, dropped mean glucose by 13, and decreased hyperglycemia of more than 180 by 10 percent.
“One hundred percent of our participants completed this RCT and were actively using the system at the end of the six months (of the trial),” Dr. Brown said. “The benefit of the closed-loop system was realized in the first month and consistently sustained over the six months.”
The study utilized a t:slim X2 Insulin Pump with Control-IQ Technology and Web-based Software Updater, a Dexcom G6 continuous glucose monitor, and unique algorithm features, including automated insulin-correction boluses, a dedicated hypoglycemia safety system, and gradually intensified control overnight, sliding the algorithm target range down to achieve blood glucose levels of approximately 110 mg/dL to 120 mg/dL by the morning. Study participants were randomized 2:1 into the CLC group and SAP group, respectively.
Researchers found their results were consistent across a wide range of A1C measurements, from 5.4 to 10.6, and across a variety of ages, from 14 to 71, including the multiple daily injection participants in this study.
“Participants achieved closed-loop control use rates of a median of 92 percent over the six months, and they reported high rates on ease-of-use, trust, and usefulness. In this RCT, the closed-loop control system was superior to SAP in all of our outcomes tested,” said Dr. Brown, who also noted that there were no hypoglycemic events in either group and one diabetic ketoacidosis (DKA) event in the CLC group due to infusion site failure.
Preliminary results from a French study comparing 24-hour use of a CLC system versus nighttime use in prepubertal children also showed promising results.
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, reported on an interim analysis of the Freelife Kid AP Study that included 30 participants with type 1 diabetes between the ages of 6 and 12. The interim analysis examined the feasibility, safety, and efficacy of closed-loop insulin therapy.
“Closed-loop control with a control-to-range algorithm embedded in an insulin pump wirelessly connected to continuous glucose monitoring is effective more than 95 percent of the time over 12 weeks in prepubertal type 1 diabetes kids,” said Dr. Renard, who added that the study indicates the artificial pancreas system was fully safe with no harmful events when used 24/7 in the study population, including no DKA events, no severe hypoglycemia, and no hospital admissions.
“Overnight results are impressive, more than 80 percent of time-in-range. The time below 60 mg/dl was significantly reduced, so very few risks of hypoglycemia at night,” Dr. Renard said.
The 24/7 portion of the study will be extended to assess the 36-week sustainability of the CLC system, he added.