CGM for Management of Type 2 Diabetes in Pregnancy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06628453
Status
Recruiting
Apply to this trial

Conditions

  • Pregnancy
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • CGM — DEVICE
    Real-time continuous glucose monitoring

Study Details

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

Key Dates

Start date
Apr 8, 2025
Status verified
Jun 2025
Primary completion
Feb 28, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
564 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continuous Glucose Monitoring
    Real-time continuous glucose monitoring
  • No Intervention: Self-Monitoring of Blood Glucose
    Self-monitoring of blood glucose (standard of care)

Primary Outcome Measure

Time in Range (TIR) at 34 weeks gestation [ Time Frame: 33 to 35 weeks gestation ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Ashley Battarbee
[email protected]
205-975-2361
University of California at San DiegoSan DiegoCalifornia92121
Gladys Ramos, MD
[email protected]
858-657-7200
University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Kim Boggess, MD
[email protected]
919-966-2131
Oregon Health and Science UniversityPortlandOregon97213
Amy Valent, DO, MCR
[email protected]
503-418-4200
University of PennsylvaniaPhiladelphiaPennsylvania19104
Celeste Durnwald, MD
[email protected]
800-789-7366
Prisma Health Greenville Memorial HospitalGreenvilleSouth Carolina29605
Daniel Pasko, MD
[email protected]
864-455-7000
University of Texas Health Science Center at HoustonHoustonTexas77030
Michal Fishel Bartal, MD
[email protected]
832-325-7133

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California at San Diego· San Diego, CAUniversity of North Carolina - Chapel Hill· Chapel Hill, NCOregon Health and Science University· Portland, ORUniversity of Pennsylvania· Philadelphia, PAPrisma Health Greenville Memorial Hospital· Greenville, SC

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