Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 6, 2025
Date Accepted: Apr 7, 2026
Efficacy and safety of a telemedicine system in patients with gestational diabetes mellitus (TELEGLAM): a single-center, two-arm, randomized, open-label, parallel-group study
ABSTRACT
Background:
In the management of gestational diabetes mellitus (GDM), the usual medical treatment requires frequent visits for glucose monitoring and insulin dose adjustment, and this imposes significant physical, psychological and economic burdens on pregnant women. As mobile health (mHealth) platforms become increasingly integrated into diabetes care, telemedicine may help alleviate these burdens; however, evidence evaluating their effectiveness as a replacement for routine in-person GDM care remains limited.
Objective:
To evaluate the impact of telemedicine on the quality of life and costs in patients with GDM requiring insulin therapy.
Methods:
This single-center, two-arm, randomized, open-label, parallel-group study included patients with GDM who started insulin injection therapy. Participants were randomized to either the telemedicine or standard face-to-face care groups for 10 (±2) weeks. The telemedicine intervention used a smartphone-linked platform that enabled automatic transfer of glucose data from connected glucose meters and facilitated real-time video consultations. Primary endpoints included costs and patient satisfaction. Costs were assessed using claims data, transportation calculations, and wage-based productivity losses, while patient satisfaction was evaluated through changes in the Problem Areas in Diabetes Survey (PAID) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire scores. Secondary outcomes included glycemic control and perinatal outcomes.
Results:
In total, 38 participants were included, with 18 assigned to the telemedicine group and 20 to the standard care group. Total costs (32,712 [95% confidence interval [CI]: 15,412–50,013] vs. 59,202 [95% CI: 42,603–75,800] Japanese yen; $ 284 [95% CI: 134–435] vs. $ 515 [95% CI: 370–659] (purchasing power parity (PPP) -adjusted); P=.01), direct non-healthcare costs (922 [95% CI: -240–2,084] vs. 2,561 [95% CI: 1,447–3,676] yen; $ 8 [95% CI: -2–18] vs. $ 22 [95% CI: 13–32] (PPP-adjusted); P=.02) and indirect costs (8,981 [95% CI: -7,119–25,082] vs. 32,832 [95% CI: 17,384–48,279] yen; $ 78 [95% CI: -62–218] vs. $ 285 [95% CI: 151–420] (PPP-adjusted); P=.01) reduced significantly in the telemedicine group compared with the standard care group. The improvements in the PAID (-7.6 [95% CI: -13.7– -1.4; P=.02]) and DTR-QOL domain 1 (10.5 [95% CI: 0.9–20.1; P=.03]) scores from the baseline were significantly greater in the telemedicine group than that in the standard care group. Nonetheless, the glycemic control and frequency of perinatal complications were comparable between the two groups. Consultation time was similar across groups, suggesting no added workload for clinicians.
Conclusions:
In this randomized trial, mHealth-enabled telemedicine safely replaced routine in-person visits for patients with GDM requiring insulin therapy. Telemedicine significantly reduced psychological and economic burdens without compromising glycemic or perinatal outcomes, demonstrating its value as a patient-centered and cost-efficient model of care. These findings support the broader implementation of mobile-based telemedicine approaches in GDM management.
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