RESUMO
OBJECTIVE: The aim of the TELESUR-GDM study was to demonstrate the non-inferiority of the onset of maternal, fÅtal, and neonatal complications for patients with gestational diabetes mellitus (GDM) monitored by myDiabby Healthcareâ (app group) compared to patients with a classical glycaemic blood monitoring by diary (control group). MATERIALS AND METHODS: TELESUR-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. RESULTS: In 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. CONCLUSION: GDM glycaemic telemonitoring compared to patients with classic glycaemic monitoring by diary was not inferior in terms of maternal, fÅtal, and neonatal complications. Neonatal hypoglycaemia, a life-threatening event, was significantly reduced despite the observation of more neonatal jaundice cases.