Back to resultsSmartphone Application for the Management of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smartphone application
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes Mellitus in Pregnancy
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.
Sites / Locations
- Kangbuk Samsung hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
conventional management group
mobile management group
Arm Description
The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
Outcomes
Primary Outcome Measures
hemoglobin A1c levels
serum glycated hemoglobin levels
Secondary Outcome Measures
body weight
the changes in body weight
body mass index
the changes in body mass index
percent body fat
the changes in percent body fat
HOMA IR(homeostatic model assessment insulin resistance)
the changes in insulin resistance
HOMA-ß (homeostatic model assessment ß-cell dysfunction )
the changes in ß-cell dysfunction
Neonate large for gestational age
Birth weight of neonates of GDM patients
Mode of delivery
Rate of cesarean section
Full Information
NCT ID
NCT03838380
First Posted
February 8, 2019
Last Updated
February 10, 2019
Sponsor
Kangbuk Samsung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03838380
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional management group
Arm Type
No Intervention
Arm Description
The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
Arm Title
mobile management group
Arm Type
Experimental
Arm Description
The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
Intervention Type
Other
Intervention Name(s)
Smartphone application
Intervention Description
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.
Primary Outcome Measure Information:
Title
hemoglobin A1c levels
Description
serum glycated hemoglobin levels
Time Frame
up to 4 to 12weeks after delivery
Secondary Outcome Measure Information:
Title
body weight
Description
the changes in body weight
Time Frame
up to 4 to 12weeks after delivery
Title
body mass index
Description
the changes in body mass index
Time Frame
up to 4 to 12weeks after delivery
Title
percent body fat
Description
the changes in percent body fat
Time Frame
up to 4 to 12weeks after delivery
Title
HOMA IR(homeostatic model assessment insulin resistance)
Description
the changes in insulin resistance
Time Frame
up to 4 to 12weeks after delivery
Title
HOMA-ß (homeostatic model assessment ß-cell dysfunction )
Description
the changes in ß-cell dysfunction
Time Frame
up to 4 to 12weeks after delivery
Title
Neonate large for gestational age
Description
Birth weight of neonates of GDM patients
Time Frame
at the day of delivery
Title
Mode of delivery
Description
Rate of cesarean section
Time Frame
at the day of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kangbuk Samsung hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31587813
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.
Results Reference
derived
Learn more about this trial
Smartphone Application for the Management of Gestational Diabetes Mellitus
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