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Completed

NCT Number: NCT03838380

Smartphone Application for the Management of Gestational Diabetes Mellitus

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone Application

Other

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 outcomes

  1. hemoglobin A1c levels

    Time frame: up to 4 to 12weeks after delivery

    serum glycated hemoglobin levels

Secondary outcomes

  1. body weight

    Time frame: up to 4 to 12weeks after delivery

    the changes in body weight

  2. body mass index

    Time frame: up to 4 to 12weeks after delivery

    the changes in body mass index

  3. percent body fat

    Time frame: up to 4 to 12weeks after delivery

    the changes in percent body fat

  4. HOMA IR(homeostatic model assessment insulin resistance)

    Time frame: up to 4 to 12weeks after delivery

    the changes in insulin resistance

  5. HOMA-ß (homeostatic model assessment ß-cell dysfunction )

    Time frame: up to 4 to 12weeks after delivery

    the changes in ß-cell dysfunction

  6. Neonate large for gestational age

    Time frame: at the day of delivery

    Birth weight of neonates of GDM patients

  7. Mode of delivery

    Time frame: at the day of delivery

    Rate of cesarean section

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2019
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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