Development and Testing of a Mobile Application for Management of Gestational Diabetes: A Qualitative and Randomized Trial Protocol

Abstract

ObjectivesThe prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs), such as Nepal. GDM self-management, including intensive diet/lifestyle modifications and glucose monitoring, is critical to maintain glycemic control and prevent adverse maternal and child outcomes. The objective of this study is to develop a culturally appropriate mobile app that supports self-management of GDM, and additionally, test its usability and preliminary efficacy, among patients in a peri-urban hospital setting in Nepal. MethodsDhulikhel Hospital, a community-based tertiary level university hospital in Dhulikhel, Nepal, is the data collection site for this study. In the app development phase, paper prototypes for the GDM app were developed based on expert review and user-centered design approach. Focus groups and in-depth interviews were conducted with GDM patients (n = 6), healthcare providers (n = 5), and family members of GDM patients (n = 3) in order to understand facilitators and barriers to GDM self-management and to gather feedback on the paper prototypes. The final GDM app will be developed based on the user feedback and following an iterative process of product design and user testing. In the clinical trial phase, newly diagnosed GDM patients (n = 60) will be recruited, and randomized to either GDM app + standard care or standard care alone from 28 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be glycemic control measures at 6 weeks postpartum, neonatal birthweight, and rates of labor induction and caesarean delivery. ResultsQualitative data from focus groups and in-depth interviews have been collected and analyzed, and we anticipate that the clinical trial will be completed in 2022. ConclusionsApp-based lifestyle interventions for GDM management are not common, especially in LMICs where its prevalence is rapidly increasing, and as such, our study findings will have important public health relevance for a broader population. Funding SourcesNIH/FIC.