Using continuous glucose monitoring to manage type 2 diabetes during pregnancy
Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy
This study is testing whether using continuous glucose monitoring can help pregnant people with type 2 diabetes manage their blood sugar better than traditional self-monitoring methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 564 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT06628453 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if continuous glucose monitoring (CGM) is more effective than self-monitoring of blood glucose (SMBG) for managing type 2 diabetes in pregnant individuals. Participants will be randomly assigned to either CGM or SMBG and will monitor their blood sugar levels throughout their pregnancy. The study will also assess various risk factors that may contribute to complications for both mothers and infants. Blood samples will be collected at multiple points to evaluate glycemic control and other health indicators.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18-50 with type 2 diabetes requiring insulin or oral medications, diagnosed before pregnancy or early in gestation.
Not a fit: Patients with multiple gestations, major fetal anomalies, or those unable to wear CGM due to skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and infant health outcomes during pregnancies complicated by type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater * Pregnant with viable fetus at 6 to less than 23 weeks gestation * Maternal age 18-50 years old Exclusion Criteria: * Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions * Multiple gestation * Major fetal anomaly or two or more minor fetal anomalies * Planned delivery outside study consortium * Participating in another conflicting interventional study * Participation in this trial in a previous pregnancy * Patient unable to consent * Physician refusal for other reasons
Where this trial is running
Birmingham, Alabama and 6 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of California at San Diego — San Diego, California, United States (Recruiting)
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Battarbee, MD, MSCR — University of Alabama at Birmingham
- Study coordinator: Ashley Battarbee, MD, MSCR
- Email: anbattarbee@uabmc.edu
- Phone: 205-975-2361
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.