Smartphone Application for the Management of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838380
• Other study ID #: KBSMC2016-11-049
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: February 2019
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• Smartphone application
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.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c levels	serum glycated hemoglobin levels	up to 4 to 12weeks after delivery
Secondary	body weight	the changes in body weight	up to 4 to 12weeks after delivery
Secondary	body mass index	the changes in body mass index	up to 4 to 12weeks after delivery
Secondary	percent body fat	the changes in percent body fat	up to 4 to 12weeks after delivery
Secondary	HOMA IR(homeostatic model assessment insulin resistance)	the changes in insulin resistance	up to 4 to 12weeks after delivery
Secondary	HOMA-ß (homeostatic model assessment ß-cell dysfunction )	the changes in ß-cell dysfunction	up to 4 to 12weeks after delivery
Secondary	Neonate large for gestational age	Birth weight of neonates of GDM patients	at the day of delivery
Secondary	Mode of delivery	Rate of cesarean section	at the day of delivery