Related Experiment Video
Updated: Dec 10, 2025
Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
Published on: December 1, 2023
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Marc D Breton1, Lauren G Kanapka1, Roy W Beck1
1From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).
Insights
A closed-loop insulin delivery system, or artificial pancreas, significantly improved glucose control in children with type 1 diabetes over 16 weeks. This advanced technology led to more time within the target glucose range compared to traditional insulin pumps.
Area of Science:
- Pediatric Endocrinology
- Biomedical Engineering
- Diabetes Technology
Background:
- Type 1 diabetes management in children presents challenges in maintaining optimal glycemic control.
- Closed-loop insulin delivery systems, also known as artificial pancreases, are emerging as a potential solution.
Purpose of the Study:
- To evaluate the efficacy of a closed-loop insulin delivery system compared to a sensor-augmented insulin pump in children with type 1 diabetes.
- To assess the impact on time spent within the target glucose range (70-180 mg/dL).
Main Methods:
- A 16-week, multicenter, randomized, open-label trial involving 101 children (6-13 years) with type 1 diabetes.
- Participants were assigned 3:1 to either a closed-loop system or a sensor-augmented insulin pump.
- Continuous glucose monitoring was used to measure the primary outcome: percentage of time glucose levels were in the target range.
Main Results:
- The closed-loop group showed a significant increase in time within the target glucose range (67% vs. 55% in the control group), an average difference of 11 percentage points (2.6 hours/day).
- Both groups maintained low percentages of time with glucose levels below 70 mg/dL (1.6% vs. 1.8%).
- The closed-loop system was active 93% of the time, with no severe hypoglycemia or diabetic ketoacidosis in either group.
Conclusions:
- Closed-loop insulin delivery systems are effective in improving glycemic outcomes in children with type 1 diabetes.
- This technology offers a significant advantage in maintaining glucose levels within the target range, enhancing patient safety and management.
Background:
A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.
Methods:
In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
Results:
A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
Conclusions:
In this 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. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).
Related Concept Videos
01:15Diabetes: Management and Pharmacotherapy
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
01:22Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
01:16Insulin: Dosing Regimen and Adverse Effects
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
01:22Diabetes Mellitus: Type 2 and Gestational
01:13Randomized Experiments
Simple randomization
Simple...
01:17Open and closed-loop control systems
An open-loop control system operates without feedback from the output. It consists of two primary elements: the controller and the controlled process. The controller receives an input signal...