Efficacy of a Connected Insulin Pen Cap in People With Noncontrolled Type 1 Diabetes: A Multicenter Randomized Clinical Trial

• DOI: 10.2337/dc22-0525
• Publication Date: 2022-11-30T15:07:06Z
• Authors: Fernando Gomez-Pe...; Cristina Abreu; Elsa Fernández-Rubio; Laura Cotovad; Pedro Pujante; Sonia Gaztambide; Diego Bellido; Edelmiro Menéndez...; Santiago Ruiz-Val...; Hugo Bello; Xoan Valledor; Jesús Pérez-González; Luis Ruiz-Valdepeñas
• Keywords: Diabetes management

OBJECTIVE To assess the efficacy of insulin pen cap Insulclock on improving glycemic control, treatment adherence, and user 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 6-week double-arm which participants were randomly assigned into an active or masked mode. RESULTS Fifty-five evaluable (active group, n = 26, 29). The increase time range was higher versus group (5.2% vs. −0.8%; P 0.016). showed reduction mean glucose, glucose management indicator, above range, high blood index. On-time doses increased decreased group. CONCLUSIONS system use associated improved variability, hyperglycemia risk, adherence uncontrolled