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

Telemedicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198857
• Other study ID #: RUPro2019001883/Pro2019002841
• Secondary ID: 1R21TW011377
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: August 18, 2025

Study information

• Verified date: December 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Shristi Rawal, PhD
• Phone: 973-972-2710
• Email: shristi.rawal[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The prevalence of gestational diabetes mellitus (GDM) is rapidly increasing worldwide, particularly in low- and middle-income countries (LMICs). Tight glycemic control via diet and lifestyle modification is critical to treating GDM and preventing its adverse health consequences, including increased risk of type 2 diabetes (T2D), in women and their children. However, in many resource-limited countries including Nepal, time for diet/lifestyle counseling often competes with other components of antenatal care. Mobile health (mHealth) technology can be leveraged to promote healthy behaviors, and support self-management and treatment of GDM, but this approach has not been tried previously in any 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 (GDM-DH), and test its usability and preliminary efficacy, among patients in a tertiary level, university hospital of Kathmandu University, Nepal. Based on the Social Cognitive Theory framework for behavior change, this app will assist in self-management of GDM by increasing the patient's knowledge and self-efficacy to adhere to the recommended diet and physical activity regimens. 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. In the requirements gathering phase, 6 GDM patients will be recruited into a focus group to view paper prototypes and provide feedback on its features and functions. Additional questions will be asked about their perceived barriers, facilitators, and strategies for lifestyle modification. Key informant interviews will also be conducted with 5 clinicians (gynecologists, dietician, physical therapist) and 3 family members, asking them to provide feedback on the GDM-DH prototype, especially pertaining to the usefulness and format of the graphic summaries of patient data. After revising paper prototypes and developing the first digital prototype, six additional patients with GDM will be recruited for two rounds of usability testing including think-aloud protocol and focus group discussions. Final prototype will be developed following an iterative process of product design and user testing. After developing the app, the investigators will recruit 120 women who are newly diagnosed with GDM, and randomly assign them to one of two treatment conditions: either (A) standard care + telemonitoring alone, or (B) GDM-DH app + standard care + telemonitoring, from 30 weeks of gestation to delivery. All participants will receive bio-monitoring devices for the self-monitoring of blood pressure and blood glucose. Although the fundamental elements of the telemonitoring support are the same between the two groups, patients in the app group will be able to leverage the technological features in the app to aid with self-monitoring.

In addition to 120 women with GDM, we will also be enrolling 100 women who do not have GDM but failed the glucose challenge test (GCT) in the first screening step of the 2-step diagnostic test for GDM. Women who had high GCT (thus failed the GCT screening) but are not diagnosed GDM are also at increased risk of adverse pregnancy outcomes and are also recommended to adopt diet/lifestyle modification in our study site (Dhulikhel Hospital). In addition to randomizing 120 GDM women in a clinical trial, we will also randomize 100 high GCT women to one of two treatment conditions: either (A) standard care alone or (B) GDM-DH app + standard care, for the rest of their pregnancies.

Block randomization will be utilized to split GDM patients and high GCT patients evenly amongst the two treatment groups. The 120 GDM women will be randomized into two groups of 60. The high GCT women will be randomized into two groups of 50. Patients in Treatment A will receive standard care alone, regardless of diagnosis. Patients in Treatment B will receive GDM-DH app + standard care. All women diagnosed with GDM will receive telemonitoring in addition to their standard care, whereas women diagnosed with high GCT only will not.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 18, 2025
• Est. primary completion date: April 18, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with learning difficulties or vision/hearing impairments

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital, Kathmandu University Hospital	Dhulikhel	Kavrepalanchok

Sponsors (5)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Dhulikhel Hospital, Fogarty International Center of the National Institute of Health, Nepal Health Research Council, University of Connecticut

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Primary cesarean delivery	Primary cesarean delivery (yes/no) will be abstracted from the medical records at delivery.	up to 16 weeks after recruitment
Primary	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	Maternal gestational weight gain	The absolute weight gained by the pregnant mother over pregnancy will be calculated by subtracting the measured weight at or before 12 weeks' gestation from last measured weight before delivery. These weights will be abstracted from the medical records at delivery.	up to 16 weeks after recruitment
Secondary	Usability of the GDM app	App usability will also be assessed through a mHealth app usability questionnaire (MAUQ). Out of the four versions of MAUQ previously validated for usability studies, the version we will be using is specifically designed for patient feedback on an interactive mHealth app. The users will completed the 21 questions and the average score will be determined, with higher score indicating higher user usability of the app.	up to 22 weeks after recruitment
Secondary	Acceptability	At six weeks postpartum, the Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ), a validated tool will be administered to assess general satisfaction and acceptability of technology use for diabetes care. This questionnaire comprises of 9 questions designed to assess general satisfaction with treatment, the acceptability and reliability of the technology, and the perceived relationship with the treatment team. Women will be asked to score their agreement with statements on a 7-point Likert-type scale, ranging from +3 (strongly agree) to -3 (strongly disagree).	up to 22 weeks after recruitment
Secondary	Usability of telemonitoring	At 6 weeks postpartum, the System Usability Scale (SUS), a 10-item 5-point Likert scale questionnaire on usability and human-computer interaction, will be administered to assess the perceived usability of the telemonitoring system. Good usability is indicated by SUS score of above 65 (maximum score 100; scores range 0-100).	up to 22 weeks after recruitment
Secondary	Self-monitoring blood pressure adherence	Self-monitoring adherence will be measured by the number of blood pressure entries in the app over the entire monitoring period	recruitment to delivery
Secondary	Self-monitoring glucose adherence	Self-monitoring adherence will be measured by the number of blood glucose entries in the app over the entire monitoring period	recruitment to delivery
Secondary	App Usage	App usage will be defined as the number of times the app was opened over the entire monitoring period.	recruitment to delivery
Secondary	Antenatal care adherence	Antenatal care adherence will be measured by the number of prenatal appointments attended over the entire monitoring period	recruitment to delivery
Secondary	Apgar scale	The average Apgar score of the neonates will be compared between the two treatment groups. The data will be abstracted from the medical records of the patients in both treatment groups at delivery.	up to 16 weeks after recruitment
Secondary	NICU admittance	will be abstracted from the medical records at delivery.	up to 16 weeks after recruitment
Secondary	Proportion of insulin prescription	The number of patients whose diabetes progresses to higher levels, needing insulin for sugar control will be compared between the two treatment conditions. Information about progression to insulin therapy will be abstracted from the medical records of the patients in both the treatment groups at delivery.	up to 16 weeks after recruitment
Secondary	Induction of labor	Induction of labor (yes/no) will be abstracted from the medical records at delivery.	up to 16 weeks after recruitment
Secondary	Glucose readings over glycemic target	Frequency of glucose levels above the glycemic target will be compared between the two groups over the course of their pregnancy. To determine the frequency, the number of fasting glucose levels taken pre-meal and 2 hours post meal that surpass the glycemic targets will be divided by the total number of entries. The glycemic targets are	up to 16 weeks after recruitment