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A 13-week trial examining use of the Control-IQ closed-loop insulin delivery system in children aged 2-6 years, results of PEDAP indicate use of the closed-loop system was associated with a 3 hour per day increase in time in range relative to standard care.
Closed-loop control systems of insulin delivery could see its use expand into a new patient population based on the safety and efficacy profile from the PEDAP trial.
A 13-week multicenter trial of 102 children aged at least 2 years of age but younger than 6 years of age with type 1 diabetes, results of the trial indicate use of the Control-IQ system was associated with a 3 hour per day increase in time in target range, with no significant between group difference for time below 70 mg/dL.
“After the resounding success of Control-IQ technology in people ages 6 and up, it is very rewarding to see our youngest patients, and often the most challenging patients to help, benefit as well,” said principal investigator Marc D. Breton, PhD, a researcher at the University of Virginia.2 “With these results, we have now accumulated years of clinical validation of this system across all age groups and look forward to seeing this life-changing technology made available to the broadest possible population.”
As study after study continues to promote the benefits of continuous glucose monitoring and insulin delivery systems, the diabetes community has seen use expand into younger patient populations. In the current study, Breton and a team of colleagues sought to further explore the safety and efficacy of initiating a closed-loop system in children aged 2-6 years who had type 1 diabetes. With this in mind, the Pediatric Artificial Pancreas (PEDAP) trial was designed as a multicenter, unblinded, parallel-group, randomized, controlled trial and was conducted in pediatric diabetes centers at 3 universities in the US.1
With funding from the National Institute of Diabetes and Digestive and Kidney Diseases and the closed loop insulin pump and infusion supplies provided by Tandem Diabetes Care, the trial compared use of the system to standard care. Per trial protocol, patients randomized to standard care continued to use the insulin-delivery method they were using before the trial.1
The primary outcome of interest for the trial was the percentage of time in target glucose range of 70-180 mg/dL. The trial included multiple secondary outcomes of interest, such as percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. Investigators noted time in range was measured using the Dexcom G6 continuous glucose monitoring system.1
From April 28, 2021-January 13, 2022, a total of 102 patients were randomized to the closed-loop group or standard care, with 68 randomized to closed-loop therapy and 34 randomized to standard care. When examining baseline age of the cohort, investigators pointed out 46% were younger than 4 years of age. Further analysis of patient characteristics indicated 65% had been using insulin pumps, 35% had been receiving multiple daily injections, 98% had been using a continuous glucose monitor. Investigators also pointed out the overall study cohort had an HbA1c range of 5.2-11.5% at baseline.1
Upon analysis, the mean percentage of time in range increased from 56.7±18.0% to 69.3%±11.1% during the 13-week follow-up period in the closed loop group and from 54.9±14.7% to 55.9±12.6%, which investigators pointed out was equivalent to a 3 hours per day difference (mean adjusted difference, 12.4 percentage points [95% confidence interval [CI], 9.5-15.3]; P <.001). Additionally, similar treatment effects favoring the closed-loop system when assessing the percentage of time with a glucose level above 250 mg/dL, mean glucose level, and glycated hemoglobin level, with no significant between-group differences in time spent below 70 mg/dL.1
Safety analyses demonstrated there was 2 cases of severe hypoglycemia in the closed-loop group and 1 case in the standard care group. Safety analyses also indicated a single case of diabetic ketoacidosis occurred among the closed-loop group.1
“At the end of the day, this technology significantly improved glycemia and ensured safety of our youngest patients, but perhaps just as importantly it lessened these families’ constant anxiety about glucose levels, especially during the night.” Breton said.2 “It is incredibly rewarding for us to hear about these families’ experiences and how they manage to integrate these new tools in their life, offering some reprieve to the challenges they face.”