Hybrid closed-loop control is superior to standard care in young children with type 1 diabetes

Abstract

Recent years have seen the development of technology for the management of patients with type 1 diabetes. One such technology is the closed-loop control systems of insulin delivery. Also known as the ‘artificial pancreas’, this is a system where an insulin pump and a continuous glucose monitor ‘talk’ to each other via a computer algorithm inside a phone or a pump. While evidence for efficacy and safety for this technology in adults or adolescents with type 1 diabetes have been established, the efficacy and safety of initiating a closed-loop system in young children remains unclear. In a 13-week multicentre trial published in the New England J Medicine,¹ children aged 2–6 years were randomly assigned in a 2:1 ratio to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg/dL (3.9 to 10 mmol/L), as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg/dL (13.9 mmol/L) or below 70 mg/dL (3.9 mmol/L), the mean glucose level, HbA1c level, and safety outcomes. A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group). Baseline HbA1c ranged from 5.2% to 11.5%. The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7 ± 18.0% at baseline 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% in the standard-care group (mean adjusted difference, 12.4%) Benefits of close loop system was also seen in the percentage of time that the glucose level was above 250 mg/dL (13.9 mmol/L), on the mean glucose level, and on the HbA1c reduction, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg/dL (3.9 mmol/L). Two cases of severe hypoglycaemia in the closed-loop group and one case in the standard-care group was observed. In addition, one case of diabetic ketoacidosis occurred in the closed-loop group. Overall, this trial provided strong evidence for the safety and efficacy of the hybrid close-loop system for young children with type 1 diabetes compared with standard care.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, (NCT04796779).