Hybrid Closed Loop Overcomes the Impact of Missed or Suboptimal Meal Boluses on Glucose Control in Children with Type 1 Diabetes Compared to Sensor-Augmented Pump Therapy.

Background It is unclear whether hybrid closed-loop therapy (HCL) attenuates the metabolic impact of missed or suboptimal meal insulin bolus compared with sensor-augmented pump therapy (SAP) in children with type 1 diabetes in free-living conditions. Methods This is an ancillary study from a multicenter randomized controlled trial that compared 24/7 HCL to evening and night (E/N) HCL for 36 weeks in children between 6 and 12 years old. In the present study, the 60 children from the E/N arm underwent a SAP phase, an evening and night (E/N) HCL for 18 weeks, then a 24/7 phase for 18 weeks, extended for 36 more weeks. The last 28-30 days of each of the four phases was analyzed according to meal bolus management (cumulated 6817 days). The primary endpoint was the percentage of time that the sensor glucose was in the target range (TIR, 70 to 180 mg/dl) according to the number of missed boluses per day. Findings TIR was 54±10% with SAP, 63± 7% with E/N HCL, and steadily 67±7% with 24/7 HCL. From the SAP phase to 72 weeks of HCL, the percentage of days with at least one missed meal bolus increased from 12% to 22%. Estimated marginal (EM) mean TIR when no bolus was missed was 54% (95% CI 53-56) in SAP and it was 13% higher (95% CI 11-15) in the 24/7 HCL phase. EM mean TIR with 1 and ≥ 2 missed boluses/day was 49.5% (95% CI 46-52) and 45% (95% CI 39-51) in SAP, and it was 15% (95% CI 14-16) and 17% higher (95% CI 6 to 28), respectively in 24/7 HCL phase (p<0.05 for all comparisons vs. SAP). Interpretation HCL persistently improves glycemic control compared to SAP, even in case of meal bolus omission.