The goal of this pilot study is to test the feasibility and preliminary impact of "MyGlucoCare," a smartphone-based program designed to support women with gestational diabetes (GDM). The main questions it aims to answer are:
Is the "MyGlucoCare" program practical and acceptable for participants?
Does it show preliminary signs of improving self-management, blood sugar control, and well-being in women with gestational diabetes (GDM)?
Researchers will conduct a single-arm study to gather initial data on the program's use and effects, which will be used to plan a larger future clinical trial.
Participants will:
Use the "MyGlucoCare" app for 8-12 weeks during their pregnancy.
Receive personalized education, support from a clinician, and access to a moderated peer group through the app.
Complete questionnaires and log health data via the app at the start, near the end of pregnancy, and after giving birth.
Some participants will also take part in an interview to share their feedback on the program.
Pregnant women diagnosed with Gestational Diabetes Mellitus (GDM) via a 75g Oral Glucose Tolerance Test (OGTT), conducted between 24 and 28 weeks of gestation (Hong Kong College of Obstetricians and Gynaecologists, 2016).
Aged 18 years or older.
Own a smartphone with reliable internet access.
Able to read and understand Chinese.
Pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus.
Known major fetal anomaly.
Concurrent enrollment in any other structured GDM self-management intervention.
Severe mental health conditions.
Single group
MyGlucoCare
DeviceThe "MyGlucoCare" intervention is a comprehensive, technology-facilitated program delivered over 8 to 12 weeks. It integrates three core components to provide holistic and personalised support for women with gestational diabetes (GDM).
Enagagement
Measures participant interaction with the study protocol and app (%). • Measures: Mean/median frequency of (e.g., per week)
Recruitment & Retention Rates
Assesses the practicality of executing the trial. • Unit of Measure: Proportion/Percentage (%) for each
System Usability
Quantifies the perceived usability of the "MyGlucoCare" app using a validated instrument.• Measure: Mean score on the System Usability Scale (SUS). • Unit of Measure: Score on a scale (0-100).
Secondary outcome measures
Change in Diabetes Management Self-Efficacy Score (DMSES, 20-200; higher=better). Change in Diabetes Self-Care Activities frequency (SDSCA, 0-7 days/week; higher=better). Change in Self-Monitored Blood Glucose (fasting \& postprandial mmol/L; lower=better). Postpartum Glucose Tolerance Status (% with normal OGTT at 6-12 weeks postpartum). Change in Depressive Symptom Score (PHQ-9, 0-27; higher=worse). Maternal and Neonatal Delivery Outcomes: gestational age, mode of delivery, birth weight, and neonatal hypoglycemia.
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