Efficacy of a connected insulin pen cap in people with non-controlled type 1 diabetes mellitus: a multicenter randomized clinical trial

Objective: To assess the efficacy of the insulin pen cap Insulclock® on improving glycemic control, treatment adherence, and users’ satisfaction in people with type 1 diabetes.

Research Design and Methods: This multicenter, open-label, randomized, controlled trial comprised a 4-week run-in phase and a 6-week double-arm phase, in which participants were randomized to use Insulclock® into an active or masked mode.

Results: Fifty-five participants were evaluable (active group: 26, masked group: 29). The increase in TIR was higher in the active vs. the masked group (+5.2% vs. -0.8%; p=0.016). The active group showed a higher reduction in mean glucose, glucose management indicator (GMI), time above range (TAR), and high blood glucose index (HBGI). On-time insulin doses increased in the active group and decreased in the masked group.

Conclusions: Insulclock® system use was associated with improved glycemic control, glycemic variability, hyperglycemia risk, and treatment adherence in people with uncontrolled type 1 diabetes.