Introduction: My Dose Coach (MDC) is an app designed for basal insulin dose titration that has demonstrated its versatility in several clinical studies. We evaluated its effect on the maintenance of glycemic control for 28 weeks in patients with type 2 Diabetes.
Objective: Compare the efficacy of 2 basal insulin titration strategies: MDC vs. Conventional Titration (CT) to maintain glycemic control (HbA1c < 7% and fasting plasma glucose -FPG- between 90-130 mg/dL) . Research Design and Methods: We design controlled and randomized clinical trial lasting 28 weeks, we included 80 patients with uncontrolled type 2 Diabetes (HbA1c between 8-10%) and without previous treatment with insulin. They were randomized into 2 groups: online insulin dose titration using the MDC app vs. CT in person every 2 weeks. At week 25, all enrolled patients titrated their dose in a conventional manner to assess the effect of discontinuing use of the app.
Results: We included 40 patients per group, with a mean age of 52.7 years and a duration of type 2 Diabetes of 8.1 years. A total of 36 subjects (90%) vs. 33 (82.5%) completed the study, p 0.215. In the initial evaluation the following results were obtained: baseline FPG 172 vs. 167 mg/dL, p 0.98, HbA1c 9 vs. 8.9%, p 0.497, initial dose of insulin Glargine (U-100/U-300) 16.9 vs. 17.6 IU, p 0.122, MDC vs. CT respectively. Evaluation at 24 weeks, glucose 106 vs. 110 mg/dL, p 0.69, HbA1c 6.87 vs. 7.08 %, p 0.016, mean HbA1c reduction -2.10 vs. -1.83 %, p 0.015. Final insulin dose 29.9 vs. 34.1 IU, p 0.004, mean time to FPG goal 18 vs. 26 days, p 0.001. When suspending the titration by means of the application in the week 25 to 28 average glucose increased 138.5 vs. 142 mg/dL p 0.605, MDC vs. CT respectively.
Conclusions: My Dose Coach app is an effective digital insulin glargine titration tool in real-world patients with uncontrolled type 2 Diabetes, as the number of participants achieving established control goals was higher and lasted longer. Fulfilling the objective of the study with lower doses of insulin and achieving stability in FPG in a considerably shorter time.
M. A. Polanco: None.