Gestational Diabetes Mellitus in Pregnancy
Conditions
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.
Interventions
OTHERSmartphone application
Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level. The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients. The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information. Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin A1c levels | up to 4 to 12weeks after delivery | serum glycated hemoglobin levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index | up to 4 to 12weeks after delivery | the changes in body mass index |
| percent body fat | up to 4 to 12weeks after delivery | the changes in percent body fat |
| HOMA IR(homeostatic model assessment insulin resistance) | up to 4 to 12weeks after delivery | the changes in insulin resistance |
| body weight | up to 4 to 12weeks after delivery | the changes in body weight |
| Neonate large for gestational age | at the day of delivery | Birth weight of neonates of GDM patients |
| Mode of delivery | at the day of delivery | Rate of cesarean section |
| HOMA-ß (homeostatic model assessment ß-cell dysfunction ) | up to 4 to 12weeks after delivery | the changes in ß-cell dysfunction |
Countries
South Korea
Outcome results
None listed