Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 6, 2025
Date Accepted: Apr 7, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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, and this imposes significant physical, psychological and economic burdens on pregnant women.
Objective:
To evaluate the impact of telemedicine on the quality of life and costs in patients with GDM.
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 care groups. Primary endpoints, including costs and patient satisfaction, were assessed 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; p=0.011), direct non-healthcare costs (922 [95% CI: -240–2,083] vs. 2,561 [95% CI: 1,447–3,676] yen; p=0.018) and indirect costs (8,981 [95% CI: -7,119–25,082] vs. 32,832 [95% CI: 17,384–48,279] yen; p=0.013) 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=0.018]) and DTR-QOL domain 1 (10.5 [95% CI: 0.9–20.1; p=0.033]) 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.
Conclusions:
Replacing regular consultations with telemedicine for patients with GDM reduced both psychological and economic burdens without compromising glycemic or perinatal outcomes.
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