Abstract
Background and Aims
Insulclock is an electronic device designed to improve treatment adherence and insulin injection tracking.We aimed, for the first time, to asses the impact of Insulclock on disease outcomes
Methods
Randomized, single-center, pilot study. We evaluated glycemic control, number of missed and mistimed insulin doses and quality of life after four weeks of Insulclock use in patients with uncontrolled T1DM. We also compared these outcomes between patients with or without receiving reminders and device alerts (Active or Blinded groups, respectively).
Results
Twenty one participants were recruited. Sixteen participants completed the study: 10 in the Active group and six in the Blinded group. The use of Insulclock was associated with a significant decrease in mean glucose levels (-27.0 mg/mL , p = 0.0126), a non-significant decrease (-2.8%, p = 0.6523) in the coefficient of variation (CV), and a significant increase in time in range (TIR) in the overall population (+7%, p = 0.038). No significant differences were observed in the change in HbA1C levels (-0.27%, p = 0.4098). TIR was more reduced in the Active group (-8%, p = 0.026). The number of missed and mistimed insulin doses decreased (-3.9; p = 0.1352, and -5.4; p = 0.0323, per month, respectively) in the overall population. Most of the items of The Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after four weeks of Insulclock use.
Conclusions
This pilot study showed that Insulclock contributes to improving glycemic indices, decreasing missed and mistimed insulin doses, and improves treatment satisfaction in DM1 patients with persistent uncontrolled glycemic levels.
