Using continuous glucose monitoring for women with gestational diabetes
CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
NA · Yale University · NCT04219085
This study tests if using continuous glucose monitoring can help women with gestational diabetes have healthier pregnancies compared to the usual method of checking blood sugar levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04219085 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuous glucose monitoring in women diagnosed with A2 gestational diabetes. Participants will be randomly assigned to either receive continuous glucose monitoring or standard care, which involves checking blood glucose levels through fingersticks four times daily. The primary goal is to determine if continuous monitoring leads to better pregnancy outcomes, including reduced rates of perinatal death, birth trauma, and NICU admissions. The study aims to optimize treatment for gestational diabetes and improve maternal and fetal health.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-50 with a diagnosis of A2 gestational diabetes requiring medication between 24-36 weeks of gestation.
Not a fit: Patients with pregestational diabetes, multiple gestations, or significant maternal comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pregnancy outcomes and reduced complications for women with gestational diabetes.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring in diabetes management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women between 18-50 years old * pregnant * singleton gestation * diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation Exclusion Criteria: * pregestational diabetes * diagnosis with gestational diabetes \< 24 weeks gestation or \> 36 weeks gestation * known fetal anomalies * fetal growth restriction diagnosed during the current pregnancy * diagnosis of polyhydramnios at time of randomization * abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization * twin or higher order multiple gestation * non-compliance with prenatal visits (missing ≥3 visits prior to enrollment) prior to diagnosis with A2 gestational diabetes * maternal medical comorbidities including the following: lupus, chronic hypertension, cancer, ischemic cardiovascular disease
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Audrey Merriam, MD, MS — Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
- Study coordinator: Audrey Merriam, MD, MS
- Email: audrey.merriam@yale.edu
- Phone: (203) 688-2800
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, Maternal Complication of Pregnancy, gestational diabetes, fetal or neonatal outcomes, maternal morbidity