Development and Testing of a Mobile Health Application for Management of Gestational Diabetes

NCT04198857 | Recruiting

• 2 other identifiers: RUPro2019001883/Pro20190028411R21TW011377
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate control and management of gestational diabetes mellitus (GDM) during pregnancy is critical to mitigate its short- and long-term health consequences in women and their children and may serve as a key strategy to curb the escalating type 2 diabetes epidemic in low- and middle-income countries (LMICs). Taking a user-centered design approach, here the study investigators propose to develop a culturally-appropriate smartphone application (app) to support self-management of GDM, and additionally, test its usability and preliminary efficacy, among patients in a peri-urban hospital setting in Nepal. App-based lifestyle interventions for GDM management are not common, especially in LMICs where its prevalence is rapidly increasing, and as such, study findings will have important public health relevance for a broader population.

Conditions

Diabetes, Gestational; Telemedicine

Outcome Measures

Primary Outcomes (4)

• Maternal blood glucose levels at 6 weeks postpartum

  Six weeks after delivery, all participants will undergo 100-g OGTT. From blood samples collected, fasting and 2-hour glucose levels will be measured in the hospital laboratory using standard laboratory methods.

  up to 22 weeks after recruitment

• Neonatal birth weight

  prior to discharge, less than 24 hours after delivery, birthweight will be obtained from the medical records

  up to 16 weeks after recruitment

• Primary cesarean delivery

  Primary cesarean delivery (yes/no) will be abstracted from the medical records at delivery.

  up to 16 weeks after recruitment

• Neonatal hypoglycemia

  Proportion of neonates with neonatal hypoglycemia will be compared between the two treatment groups. The data will be abstracted from the medical records at delivery.

  up to 16 weeks after recruitment

Secondary Outcomes (13)

• Maternal gestational weight gain

  up to 16 weeks after recruitment

• Usability of the GDM app

  up to 22 weeks after recruitment

• Acceptability

  up to 22 weeks after recruitment

• Usability of telemonitoring

  up to 22 weeks after recruitment

• Self-monitoring blood pressure adherence

  recruitment to delivery

Study Arms (2)

Standard Care + Telemonitoring: Control

NO INTERVENTION

Standard care for GDM will be modifying diet\& exercise and/or medication use. Participants will have consultations with a dietitian and a physical therapist to develop a diet and physical activity plan based on pre-pregnancy weight and disease severity. In addition to verbal information about managing GDM with diet and physical activity, patients will be provided with leaflets and brochures. As per the standard care protocol, GDM patients will be asked to visit the OPD for glucose testing every two weeks, and after each testing, blood glucose levels will be recorded in paper booklets assigned to each patient. In addition, the women will be provided with a glucometer and a blood pressure monitor machine. Participants will be taught to use these devices for self-monitoring and will be provided guidelines to follow at home. The OB/GYN physicians will monitor the blood glucose levels across testing, and will prescribe oral hypoglycemic medications or insulin to the patient if needed.

Standard Care + GDM-DH app + Telemonitoring

EXPERIMENTAL

In addition to standard care and telemonitoring, this group will use the GDM-DH app. This group will be provided with the same devices as the control group and in addition, the GDM-DH app will be set up in their cellular device. The app will be on their smart phone and will support self-management by: i) providing health education, ii) helping patients identify and set target health goals (for diet, physical activity, and glucose levels), iii) enhancing their self-efficacy to meet target goals, and iv) facilitating desired support from family members. The core component of the GDM-DH app will be to allow GDM patients to record and self-monitor their carbohydrate intake, physical activity and blood glucose levels. Patients will be able to manually enter their weekly blood glucose levels and blood pressure readings on to the app

Behavioral: Develop a mobile app that supports self- management and treatment for Nepalese GDM patients

Interventions

Develop a mobile app that supports self- management and treatment for Nepalese GDM patients BEHAVIORAL

We will use a user-centered design approach to develop a mobile app for GDM (GDM-DH) that matches the needs and technological sophistication of the target users. The goal of the app would be to assist patients in self management of GDM by improving their adherence to the recommended diet and physical activity regimens. The app will be used to collect information such as the carbohydrate consumption, the daily activity status and blood glucose and blood pressure measurements taken at home by the patients. The app will be set up in the phone of the participants and their data will be collected. The participants will be able to assess the usability and feasibility of the app. The app will also help clinicians by generating easily digestible visual displays of patient data and behaviors, which can aid in their clinical decision-making and counseling.

Standard Care + GDM-DH app + Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receive antenatal care at Dhulikhel Hospital
• receive a GDM diagnosis based on Carpenter-Coustan criteria or fail the Glucose Challenge Test only
• less than 30 gestational weeks into pregnancy
• own a smartphone
• have internet connectivity at home
• can understand and read Nepali

You may not qualify if:

• Patients with learning difficulties or vision/hearing impairments

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Nepal Health Research Council: collaborator
• University of Connecticut: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Dhulikhel Hospital: collaborator

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Kavrepalanchok, 45200, Nepal

RECRUITING

Related Publications (1)

• Berube LT, Shrestha A, Shrestha A, Daneault JF, Shakya PR, Dhimal M, Shrestha R, Rawal S. Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 21;13:e59423. doi: 10.2196/59423.

  PMID: 39432898 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shristi Rawal, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shristi Rawal, PhD

CONTACT

973-972-2710; shristi.rawal@rutgers.edu

Emily N. Peters, MPH

CONTACT

973-972-4778; petersen@shp.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A user-centered design approach, here we propose to develop a culturally-appropriate smartphone application (app) to support self-management of GDM (GDM-DH), and test its usability and preliminary efficacy, among patients in a tertiary level hospital.

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 13, 2019
• Study Start: October 18, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)