Smartphone Application for the Management of Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: Smartphone application

• Registration Number: NCT03838380
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-10-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-10
• Last Update Submitted: 2019-02-10
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile management group	Smartphone application	The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.

Primary Outcome Measures

Name	Time	Method
hemoglobin A1c levels	up to 4 to 12weeks after delivery	serum glycated hemoglobin levels

Secondary Outcome Measures

Name	Time	Method
body mass index	up to 4 to 12weeks after delivery	the changes in body mass index
body weight	up to 4 to 12weeks after delivery	the changes in body weight
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
HOMA-ß (homeostatic model assessment ß-cell dysfunction )	up to 4 to 12weeks after delivery	the changes in ß-cell dysfunction
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

Trial Locations

Locations (1)

Kangbuk Samsung hospital; 🇰🇷 Seoul, Korea, Republic of