Background and Aims

The DBLG1 Hybrid Closed-Loop system improves time in range and glycemic control in adults. However, efficacy and safety of the system had not yet been evaluated in children.

The objective is to evaluate the non-inferiority of the DBL4K (Diabeloop for Kids) hybrid closed-loop system (Kaleido pump + Dexcom G6 = CL) compared to a Dexcom G6 sensor augmented pump (open loop = OL) in prepubescent children.

Methods

Multicenter open-label randomised controlled trial in 3 pediatric diabetology centers. The CL and OL are worn for 4 days in hospital, followed by 6 weeks at home.

Results

Twenty-one patients (mean age: 8.3+/- 1.6 years; 10 boys) were included between March and December 2019. The percentage of time spent in range (4-10 mmol/L) was identical in both groups during the 72-hour phase in hospital (68.73% in CL vs 70.53% in OL, p=0.539) then significantly higher in the CL group during the 6 weeks at home (66.19% in CL vs 58.68% in OL, p<0.001). The percentage of time spent in hypoglycemia (< 3.85 mmol/L) was significantly lower in the CL group during the 72 hours in hospital (2.04% in CL vs 7.06% in OL, p<0.001) and the 6 weeks at home (2.62% in CL vs 5.24% in OL, p<0.0001). No events of ketoacidosis or severe hypoglycemia were recorded.

Conclusions

The DBL4K Closed-Loop System is suitable for prepubescent children. Just as in adults it improves the time in range while decreasing the time spent in hypoglycemia. It could allow for better long-term glucose control in children with diabetes.