Monitoring gestational diabetes mellitus patients with myDiabby Healthcare® smartphone application vs classical diary. Results from the non-inferiority TELESUR-GDM study

Abstract

ObjectiveThe aim of the TELESUR-GDM study was to demonstrate the non-inferiority of the onset of maternal, fœtal, and neonatal complications for patients with gestational diabetes mellitus (GDM) monitored by myDiabby HealthcareⓇ (app group) compared to patients with a classical glycaemic blood monitoring by diary (control group). Materials and methodsTELESUR-GDM was a retrospective, monocentric, and non-inferiority study including 349 patients in the app group and 295 patients in the control group. The primary outcome was a composite score based on maternal, foetal, and neonatal complications. The statistical analysis used chi square or Student t tests for categorical or continuous variables, and Dunnett–Gent test for non-inferiority. ResultsIn the app and control groups, 46.3 % and 53.7 % of the patients respectively, observed complications. Non-inferiority of telemonitoring by application vs diary was confirmed (odds ratio=0.79 [95 % CI 0.58;1.07], P < 0.001). Caesarean section, labour induction, and insulin treatment rates were: 20 vs 23 % (P = 0.4), 36 vs 28 % (P = 0.047), and 22 vs 23 % (P = 0.8) in the app vs control group, respectively. Macrosomia, intrauterine growth restriction, neonatal hypoglycaemia, and neonatal jaundice rates were: 4.3 vs 6.1 % (P = 0.4), 6.9 vs 3.1 % (P = 0.04), 1.7 vs 14 % (P < 0.001), and 8.6 vs 1.0 % (P < 0.001), in the app versus control group, respectively. ConclusionGDM glycaemic telemonitoring compared to patients with classic glycaemic monitoring by diary was not inferior in terms of maternal, fœtal, and neonatal complications. Neonatal hypoglycaemia, a life-threatening event, was significantly reduced despite the observation of more neonatal jaundice cases.