NCT06628453 CGM for Management of Type 2 Diabetes in Pregnancy
| NCT ID | NCT06628453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 564 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 564 participants in total. It began in 2025-04-08 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis
Eligibility 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
Contact & Investigator
Ashley Battarbee, MD, MSCR
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06628453 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06628453 currently recruiting?
Yes, NCT06628453 is actively recruiting participants. Contact the research team at anbattarbee@uabmc.edu for enrollment information.
Where is the NCT06628453 trial being conducted?
This trial is being conducted at Birmingham, United States, San Diego, United States, Chapel Hill, United States, Portland, United States and 3 additional locations.
Who is sponsoring the NCT06628453 clinical trial?
NCT06628453 is sponsored by University of Alabama at Birmingham. The principal investigator is Ashley Battarbee, MD, MSCR at University of Alabama at Birmingham. The trial plans to enroll 564 participants.
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