Smartphone Application for the Management of Gestational Diabetes Mellitus

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Smartphone application

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 10, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: KBSMC2016-11-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No