Effectiveness of a comprehensive telemedicine intervention replacing standard care in gestational diabetes: a randomized controlled trial

Aims Telemedicine improves glycemic and perinatal outcomes when used as an adjunct to standard care in gestational dia-betes (GDM). Little is known about its effectiveness when used instead of standard care. We aimed to compare the outcomes of telemedicine care and the standard care in women with GDM. Methods In a single-center, parallel, randomized controlled trial, women were randomized to: (1) a telemedicine group, sending glucose readings via an application installed on a smartphone and monthly individual video calls replacing on-site visits or (2) standard care group with routine monthly on-site visits. The primary outcome was the effectiveness of glycemic control. The secondary outcomes were gestational weight gain (GWG) and perinatal data, including birth weight, gestational age, the incidence of the offspring large for gestational age, preterm birth, preeclampsia and cesarean section. Results A total of 106 women were randomized to the telemedicine (n = 54) and the standard care group (n = 52). The telemedicine group demonstrated less postprandial measurements above the glycemic target (10.4% [3.9-17.9] vs. 14.6% [6.5-27.1]; p = 0.015), together with lower average postprandial glucose (5.6 +/- 0.3 vs. 5.9 +/- 0.4; p = 0.004). Percentage of cesarean section was lower in the telemedicine group (9 (17.3%) vs. 18 (35.3%); p = 0.038). Conclusions Telemedicine offers an effective alternative to delivering care to women with GDM. Trial registration NCT05521893, ClinicalTrials.gov Identifier URL: https://www.clinicaltrials.gov/ct2/show/NCT05521893? term=NCT05521893&draw=2&rank=1