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

is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of 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];  = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L];  = 0.003), and time above range (-12.5%;  = 0.0026), and an increase in time in range (TIR) (+7%;  = 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%;  = 0.026). We observed a -3.9 ( = 0.1352) and -5.4 ( = 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 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.