Comparing glucose monitoring methods in pregnant women with gestational diabetes after gastric bypass surgery
The Impact of Continous Glucose Monitoring on Pregnancy Outcome, in Women With Gestational Diabetes and a History of Gastric Bypass Surgery.
This study is testing whether continuous glucose monitoring works better than traditional blood sugar checks for pregnant women with gestational diabetes who have had gastric bypass surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT06291766 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of continuous glucose monitoring (CGM) versus traditional capillary glucose measurements in women with gestational diabetes who have undergone gastric bypass surgery. Participants will be randomized to receive either CGM or standard glucose monitoring during the last trimester of their pregnancy. The study will analyze glucose levels, treatment approaches, and pregnancy outcomes to determine the impact of monitoring methods on managing gestational diabetes. The findings could help improve care for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women who have undergone gastric bypass surgery and have been diagnosed with gestational diabetes.
Not a fit: Patients who have had other types of bariatric surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of gestational diabetes in women with a history of gastric bypass surgery, potentially improving pregnancy outcomes.
How similar studies have performed: While there is limited research specifically on this population, studies on continuous glucose monitoring in gestational diabetes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Understands written and spoken Swedish * Previous Gastric Bypass surgery * Diagnosed with gestational diabetes according to our local criteria * Planned follow up at the Specialized Maternity Ward at Skane University Hospital * Understands the use of CGM and is willing to use the system * Have signed informed consent Exclusion Criteria: * Other kinds of bariatric surgery
Where this trial is running
Lund
- Region Skane — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Ulrika Moll, MD, PhD — Region Skane
- Study coordinator: Ulrika Moll, MD, PhD
- Email: ulrika.moll@skane.se
- Phone: +46733307170
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.