A randomised clinical trial comparing the efficacy of a hybrid closed-loop automated insulin delivery system with a sensor-augmented disposable patch pump in type 1 diabetes

Abstract

Background and aims: This study aimed to compare the efficacy and safety of EOPatch X, a hybrid closed-loop automated insulin delivery system (HCL AID, based on TypeZero’s inControl closed-loop algorithms), with a sensor-augmented tubeless patch pump called EOPatch M.

Materials and methods: In this multicenter, randomized, open, parallel, pivotal clinical trial, adults aged 19-69 years with type 1 diabetes were assigned in a 1:1 ratio to receive treatment with EOPatch X (HCL AID, intervention group) or EOPatch M (sensor-augmented pump, control group) for 12 weeks. The primary outcome was the percentage of time that the blood glucose level was within 70 to 180 mg/dL (time in range (TIR)), as measured by continuous glucose monitoring.

Results: A total of 104 patients underwent randomization (53 to EOPatch X and 51 to EOPatch M group), and 97 patients completed the trial, with 50 in EOPatch X and 47 in EOPatch M group. The median age and glycated hemoglobin of participants were 39 years (interquartile range (IQR), 31-46) and 6.7% (IQR, 6.1-7.2), respectively. In EOPatch X group, the percentage of time spent in the closed-loop mode was 82% (IQR, 75-90). After the 12-week trial period, TIR increased more in EOPatch X group (from 62.57±16.77% at baseline to 72.03±10.26% at endpoint) than in EOPatch M group (from 65.38±16.97% to 67.44±14.60%), with a statistical significance (p=0.001). Time below range (TBR, <70 mg/dL), time above range (TAR, >180 mg/dL), and coefficient of variation (CV) also significantly improved more in EOPatch X than in EOPatch M group (p<0.001, 0.013, and <0.001, respectively). No serious adverse events including diabetic ketoacidosis occurred in either group.

Conclusion: The use of EOPatch X was associated with a greater improvement in glycemic profiles, including TIR, TBR, TAR, and CV, than the use of EOPatch M.