Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial

Insulclock ® is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of Insulclock on glycemic control and variability, treatment adherence, and satisfaction in patients with uncontrolled type 1 diabetes mellitus (T1DM). We also compared these outcomes between the Active and Masked groups (with or without receiving reminders and app alerts). Sixteen patients completed the study: 10 in the Active group and 6 in the Masked group. Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL [1.5 mmol/L]; P  = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L]; P  = 0.003), and time above range (-12.5%; P  = 0.0026), and an increase in time in range (TIR) (+7%; P  = 0.038) in the overall population. The use of app information and alerts in the Active group was associated with an increase in TIR (+8%; P  = 0.026). We observed a -3.9 ( P  = 0.1352) and -5.4 ( P  = 0.032) reduction per month in the number of missed and mistimed insulin doses in the overall population, respectively. Most of the items of the Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after 4 weeks of Insulclock use. This pilot study points out an improvement in glycemic levels, adherence, and satisfaction in T1DM patients, supporting the development of clinical trials powered to confirm these effects.