Clinical Trials Directory

Trials / Completed

CompletedNCT03838380

Smartphone Application for the Management of Gestational Diabetes Mellitus

Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Kangbuk Samsung Hospital · Academic / Other
Sex
Female
Age
19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSmartphone applicationMobile 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.

Timeline

Start date
2017-02-01
Primary completion
2017-08-31
Completion
2017-10-31
First posted
2019-02-12
Last updated
2019-02-12

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03838380. Inclusion in this directory is not an endorsement.