Managing cardiometabolic risk in women with gestational diabetes using continuous glucose monitoring and mobile health
The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus: The Development and Application of "a Lifestyle Intervention Based on Health Belief Model Supported by Mobile Health"
NA · National Taiwan University Hospital · NCT06648174
This trial will test whether continuous glucose monitoring plus a mobile health lifestyle program helps pregnant women with gestational diabetes control blood sugar and lower cardiometabolic risk for them and their babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT06648174 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 120 pregnant women with gestational diabetes in Hsinchu, Taiwan and randomly assign them to routine finger‑prick monitoring, continuous glucose monitoring (CGM) alone, or CGM plus a health belief model–based lifestyle and mHealth program delivered from mid‑pregnancy through the postpartum period. The behavioral intervention is family‑centered and delivered via mobile health at 24–32 weeks, continued until delivery, with follow-up at 4–12 weeks postpartum. Outcomes measured at baseline, late pregnancy, and postpartum include maternal glycemic parameters, cardiometabolic risk markers, health behaviors, and infant outcomes. The trial will compare changes across the three arms to see if CGM and the added mHealth lifestyle program improve short‑term glucose control and early cardiometabolic indicators.
Who should consider this trial
Good fit: Pregnant women aged 18 or older diagnosed with gestational diabetes who can attend study visits at the Hsinchu site and are willing to use CGM and mobile health tools are ideal candidates.
Not a fit: Women with preexisting diabetes, known tape allergies, abnormal coagulation, or those unable or unwilling to use CGM or mobile technology may not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined CGM plus mHealth lifestyle program could improve blood sugar control during and after pregnancy, reduce mothers' early cardiometabolic risk, and improve infant outcomes.
How similar studies have performed: Previous work shows CGM can improve short‑term glucose control in gestational diabetes, but evidence is limited on long‑term cardiometabolic benefit and on combining CGM with an HBM‑based mHealth lifestyle program across pregnancy and postpartum.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 years or above 2. Pregnant women diagnosed with gestational diabetes mellitus 3. Willing to participate in the study Exclusion Criteria: 1. Diagnosed with diabetes mellitus before pregnancy 2. Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches) 3. Abnormal coagulation function
Where this trial is running
Hsinchu
- National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital — Hsinchu, Taiwan (RECRUITING)
Study contacts
- Principal investigator: HUNG-HUI CHEN, PhD — National Taiwan University Hostiptal
- Study coordinator: HUNG-HUI CHEN, PhD
- Email: hunghuichen@ntu.edu.tw
- Phone: 886-2-2394-7109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes Mellitus, Continuous Glucose Monitoring, Health Interventions