Monitoring glucose levels in pregnant women to improve gestational diabetes diagnosis
Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)
This study is testing if using a continuous glucose monitor can help better diagnose gestational diabetes in pregnant women of Chinese and Indian descent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06357728 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of continuous glucose monitoring (CGM) to better diagnose gestational diabetes mellitus (GDM) in pregnant women of Chinese and Indian ethnicity. It aims to correlate CGM glucose values with traditional oral glucose tolerance test (OGTT) results and assess the impact of glucose variability on maternal and fetal outcomes. By focusing on a specific population in Singapore, the study seeks to provide valuable insights into the effectiveness of CGM in managing GDM and improving pregnancy outcomes. The research will involve a single-arm intervention where participants will wear a CGM device during their pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women of Chinese or Indian ethnicity, aged 21-45 years, who are scheduled for an OGTT between 20-35 weeks of gestation.
Not a fit: Patients with pre-existing Type 1 or Type 2 diabetes, serious skin conditions, or mental illnesses that prevent informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of gestational diabetes, ultimately enhancing maternal and fetal health outcomes.
How similar studies have performed: While the use of CGM in pregnancy is gaining attention, this specific approach focusing on GDM diagnosis in an Asian population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pregnant women of only Chinese or Indian ethnicity 2. Pregnant women between age 21--45 years old 3. Oral glucose tolerance test (OGTT) to be scheduled between 20-35 weeks gestational age 4. OGTT to be done at KK Women's and Children's Hospital Exclusion Criteria: 1. Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 10 days 2. Exclusion criteria were pre-existing Type 1 or Type 2 diabetes, mental illness precluding informed consent and women who were diagnosed early (1st or early 2nd trimester for GDM).
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Phaik Ling, Elaine Quah, PhD — KK Women's and Children's Hospital
- Study coordinator: Phaik Ling, Elaine Quah, PhD
- Email: quah.phaik.ling@kkh.com.sg
- Phone: 65 97732543
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.