1. In very young children with type 1 diabetes, a hybrid closed-loop therapy provided significantly improved glycemic children.

2. The hybrid closed-loop therapy did not significantly increase the time spent in hypoglycemia in very young children with type 1 diabetes.

Evidence Rating Level: 1 (Excellent)

Study Rundown: In very young children, managing Type 1 Diabetes is difficult due to the high variability of insulin requirements and challenges in maintaining recommended glycemic control without constant caregiver monitoring. Hybrid closed-loop systems (also known as an artificial pancreas) offer an algorithm that automatically adjusts insulin delivery based on real-time sensory glucose levels and improves glycemic control in older children and adolescents, but there is a gap in knowledge as to understanding its effectiveness in improving glycemic control for very young children. This study found that the hybrid closed-loop system significantly improved glycemic control, as compared to sensor-augmented pump therapy, in children aged 1 to 7 with type 1 diabetes. This study was limited by the characterization of research participants as those who participate in closed-loop studies tend to be highly motivated, which limits generalizability. Nevertheless, these study’s findings are significant, as they demonstrate that hybrid closed-loop insulin therapy provides significant improvements in glycemic control in very young children with type 1 diabetes.

Click to read the study in NEJM

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In-Depth [randomized control trial]: This randomized control trial included 74 participants at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Patients aged 1 to 7, with the diagnosis of type 1 diabetes at least 6 months before enrollment, and glycated hemoglobin level of no more than 11% were eligible. Patients who were currently using closed-loop therapy or those with concomitant disease affecting metabolic control were excluded from the study. Patients received two 16-week treatment periods in random order, in which the hybrid closed-loop system was compared with the sensor-augmented pump therapy (control treatment). The primary outcome measured was the between-treatment difference in the percentage of time spent in the target glucose range during each 16-week period. Outcomes in the primary analysis were assessed on an intention-to-treat basis and compared with a repeated-measures linear mixed model. Between the two treatment groups, the percentage of time with glucose level in the target range was 8.7% higher when patients were using the hybrid closed-loop system as opposed to the control (95% confidence interval [CI], 7.4 to 9.9). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5% (95% CI, -9.9 to -7.1). The time spent in a hypoglycemia state did not differ significantly between the two treatment groups (p-value = 0.74). Overall, this study demonstrated that closed-loop insulin delivery provided significant improvement in glycemic control in very young children with type 1 diabetes over a treatment period of 16 weeks.

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