The DIABEO system is a telemedicine solution for real time monitoring of insulin treatment. Many people downloading a mobile health app in real-life stop using it after a single utilization. Therefore, we conducted a large pragmatic study to investigate the usage and efficacy of DIABEO in conditions close to real-life (the TELESAGE study).
Pragmatic, multicenter, randomized, open-label, three parallel-arms study in type 1 and type 2 diabetic patients poorly controlled with a basal-bolus insulin regimen (ClinicalTrials.gov NCT02287532). TELESAGE compared: (i) a control group (arm 1: standard care) versus the software alone (arm 2) and versus the software + telemonitoring by trained nurses (arm 3). The primary outcome evaluated HbA1c reduction after 12-month follow-up.
Six-hundred-sixty-five (665) patients were included in the study. Baseline characteristics of patients were comparable among the three study groups. As expected, 25.1% participants in arm 2 and 37.6% in arm 3 used the DIABEO (± telemonitoring) system one or more times per day (DIABEO users). DIABEO users showed a significant and meaningful mean HbA1c reduction versus standard care: -0.41% for arm 2 (P = 0.001) and -0.51% for arm 3 (P ≤0.001) without significant differences in hypoglycemic incidence. In the overall population (ITT) HbA1 reduction was comparable between arms.
Under pragmatic conditions, the effectiveness of DIABEO in reducing HbA1c levels in poorly controlled patients depended greatly on the frequency of its use. Significant HbA1c reductions can be obtained by using DIABEO at least once a day.