NCT03838380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 8, 2019

Last Update Submit

February 10, 2019

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • hemoglobin A1c levels

    serum glycated hemoglobin levels

    up to 4 to 12weeks after delivery

Secondary Outcomes (7)

  • body weight

    up to 4 to 12weeks after delivery

  • body mass index

    up to 4 to 12weeks after delivery

  • percent body fat

    up to 4 to 12weeks after delivery

  • HOMA IR(homeostatic model assessment insulin resistance)

    up to 4 to 12weeks after delivery

  • HOMA-ß (homeostatic model assessment ß-cell dysfunction )

    up to 4 to 12weeks after delivery

  • +2 more secondary outcomes

Study Arms (2)

conventional management group

NO INTERVENTION

The conventional management group received standard GDM management and could freely use the smartphone healthcare application.

mobile management group

EXPERIMENTAL

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

Other: Smartphone application

Interventions

Smartphone applicationOTHER

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.

mobile management group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31587813DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division of Endocrionology and metabolism, Department of Internal medicine

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

February 1, 2017

Primary Completion

August 31, 2017

Study Completion

October 31, 2017

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)