Clinical trial NCT03838380: Smartphone Application for the Management of Gestational Diabetes Mellitus
Official title: Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 21
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It is important to recognize and treat GDM to minimize the risk of maternal and neonatal complications. Multifaceted professional interventions are effective in the management of GDM and mobile healthcare can be an effective approach. The purpose of the current study was to develop and evaluate a model for prevention and management of GDM using mobile healthcare. Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks of gestation, were randomly divided into a conventional management group and a mobile management group. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received mobile healthcare services including tailored mobile coaching. The effectiveness of the management using the application were evaluated through the result values of the laboratory tests, anthropometric measurement performed during the study period and perinatal outcomes.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were included.

Exclusion Criteria:

* Patients after 30th week of gestation and patients with pregestational diabetes were excluded from participating in the study. Patients who were unable to understand Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone, or who were already receiving services from another mobile healthcare agency were also excluded.

Primary outcomes:
measure: hemoglobin A1c levels
timeFrame: up to 4 to 12weeks after delivery
Secondary outcomes:
measure: body weight
timeFrame: up to 4 to 12weeks after delivery
measure: body mass index
timeFrame: up to 4 to 12weeks after delivery
measure: percent body fat
timeFrame: up to 4 to 12weeks after delivery
measure: HOMA IR(homeostatic model assessment insulin resistance)
timeFrame: up to 4 to 12weeks after delivery
measure: HOMA-ß (homeostatic model assessment ß-cell dysfunction )
timeFrame: up to 4 to 12weeks after delivery
measure: Neonate large for gestational age
timeFrame: at the day of delivery
measure: Mode of delivery
timeFrame: at the day of delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung hospital
Study officials:
References:
citation: Sung JH, Lee DY, Min KP, Park CY. Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study. Clin Ther. 2019 Nov;41(11):2426-2434. doi: 10.1016/j.clinthera.2019.09.005. Epub 2019 Oct 4.