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

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posted on 2022-11-29, 19:33 authored by Fernando Gomez‐Peralta, Cristina Abreu, Elsa Fernández-Rubio, Laura Cotovad, Pedro Pujante, Sonia Gaztambide, Diego Bellido, Edelmiro Menéndez-Torre, Santiago Ruiz-Valdepeñas, Hugo Bello, Xoan Valledor, Jesús Pérez-González, Luis Ruiz-Valdepeñas

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.