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Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes
Julia Ware1, Janet M Allen1, Charlotte K Boughton1
1From the Wellcome Trust-Medical Research Council (MRC) Institute of Metabolic Science (J.W., J.M.A., C.K.B., M.E.W., R.H.) and the Department of Paediatrics (J.W., M.E.W., A.T., R.H.), University of Cambridge, and the Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust (S.H.), Cambridge, the Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds (F.M.C., J.Y.), and Usher Institute, University of Edinburgh, Edinburgh (J.L.) - all in the United Kingdom; Diabetes and Endocrine Care Clinique Pédiatrique, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg (C.B., U.S.); the Department of Pediatric Endocrinology, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, Brussels (C.B.); the Department of Pediatric and Adolescent Medicine (E.F.-R.), and the Division of Endocrinology and Diabetology, Department of Internal Medicine (J.K.M.), Medical University of Graz, Graz, the Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (B.R.-M., M.T., K.N.), and the Department of Pediatrics I, Medical University of Innsbruck, Innsbruck (S.E.H.) - all in Austria; the Hospital for Children and Adolescents, University of Leipzig, Leipzig, and the Hospital for Children and Adolescents "am Nicolausholz," Bad Kösen - both in Germany (T.M.K.); the Division of Pediatric Endocrinology, Stanford University, Stanford, CA (K.K.H.); Vyoo Agency, Lyon, France (S.R.); and the Jaeb Center for Health Research, Tampa, FL (J.S., L.E.B., C.K.).
Insights
Hybrid closed-loop systems significantly improve glycemic control in young children with type 1 diabetes. This artificial pancreas approach enhances time in target glucose range without increasing hypoglycemia risk.
Area of Science:
- Endocrinology
- Pediatrics
- Biomedical Engineering
Background:
- Type 1 diabetes management in very young children presents unique challenges.
- The efficacy of hybrid closed-loop (artificial pancreas) systems compared to sensor-augmented pump therapy is not well-established in this age group.
Purpose of the Study:
- To compare the effectiveness of hybrid closed-loop therapy versus sensor-augmented pump therapy in children aged 1-7 years with type 1 diabetes.
- To evaluate glycemic control metrics including time in target range, hyperglycemia, hypoglycemia, and HbA1c levels.
Main Methods:
- A multicenter, randomized, crossover trial involving 74 children (1-7 years) with type 1 diabetes.
- Participants underwent two 16-week treatment periods: hybrid closed-loop system and sensor-augmented pump therapy (control), in random order.
- Primary endpoint: difference in percentage of time glucose levels were within the 70-180 mg/dL target range.
Main Results:
- Hybrid closed-loop therapy resulted in an 8.7 percentage point increase in time spent within the target glucose range (P<0.001).
- Significant reductions were observed in time spent in hyperglycemia (-8.5%) and mean sensor glucose levels (-12.3 mg/dL) with closed-loop therapy (P<0.001).
- Time spent in hypoglycemia was similar between the two treatment groups (P=0.74).
Conclusions:
- Hybrid closed-loop systems offer a significant advantage in improving glycemic control for very young children with type 1 diabetes.
- This advanced therapy effectively reduces hyperglycemia without increasing the risk of hypoglycemia.
- The study supports the use of artificial pancreas technology in pediatric type 1 diabetes management.
Background:
The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.
Methods:
In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed.
Results:
A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred.
Conclusions:
A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).
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