Continuous glucose monitoring for pregnant women with gestational diabetes to improve mother and baby outcomes
The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes: Testing the Moderating Effects of Socioeconomic and Cultural Factors
This project will test whether using continuous glucose monitoring helps pregnant women with gestational diabetes and their babies have better health outcomes than usual monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT06436326 on ClinicalTrials.gov |
What this trial studies
This interventional study compares continuous glucose monitoring (CGM) with standard blood glucose meters alongside perinatal nursing care for pregnant women diagnosed with gestational diabetes at a Taiwan hospital. Participants will use CGM devices or traditional meters during pregnancy while researchers track glucose patterns, maternal glycemic control, medication needs, and infant outcomes such as birth weight and neonatal complications. The protocol collects data on dietary habits, socioeconomic status, and income to see if these cultural and economic factors change how monitoring method relates to outcomes. Findings aim to show whether CGM provides added benefit in this population and whether effects differ across social or dietary groups.
Who should consider this trial
Good fit: Pregnant women aged 18 or older newly diagnosed with gestational diabetes who do not have preexisting diabetes, can wear sensor adhesives, and are willing to participate are the ideal candidates.
Not a fit: Women with diabetes diagnosed before pregnancy, those with known skin allergies to adhesives, abnormal coagulation, or who cannot or will not use sensor devices may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, CGM could lead to better blood glucose control during pregnancy and fewer complications for mothers and newborns, potentially with greater benefit in groups with high-carbohydrate diets or differing socioeconomic status.
How similar studies have performed: CGM has shown good control effects in type 1 and type 2 diabetes, but randomized controlled trials in gestational diabetes are limited and have reported inconsistent results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or above * Pregnant women diagnosed with gestational diabetes mellitus * Those who are willing to participate in this study Exclusion Criteria: * Those who have been diagnosed with diabetes mellitus "before pregnancy" * Those whose skin is likely allergic to some materials such as tapes (signs and symptoms such as redness, swelling, itching, painful, presenting blisters or rashes caused by wearing breathable tapes, patches, etc.) * Those who is with 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.