Smartphone Application for the Management of Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: Smartphone application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional management group<br>The conventional management group received standard GDM management and could freely use the smartphone healthcare application. | |
| Experimental: mobile management group<br>The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching. | Other: Smartphone application<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1c levels | serum glycated hemoglobin levels | up to 4 to 12weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | the changes in body weight | up to 4 to 12weeks after delivery | 
| body mass index | the changes in body mass index | up to 4 to 12weeks after delivery | 
| percent body fat | the changes in percent body fat | up to 4 to 12weeks after delivery | 
| HOMA IR(homeostatic model assessment insulin resistance) | the changes in insulin resistance | up to 4 to 12weeks after delivery | 
| HOMA-ß (homeostatic model assessment ß-cell dysfunction ) | the changes in ß-cell dysfunction | up to 4 to 12weeks after delivery | 
| Neonate large for gestational age | Birth weight of neonates of GDM patients | at the day of delivery | 
| Mode of delivery | Rate of cesarean section | at the day of delivery |