Recruiting

CGM

Sponsor:

University of Alabama at Birmingham

Code:

NCT06628453

Conditions

Type 2 Diabetes Mellitus (T2DM)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

CGM

Study Details

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Pregnancy

Study ID

NCT06628453

Start date

Apr 8, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

564 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

CGM

Real-time continuous glucose monitoring

Primary outcome measure

  • Time in Range (TIR) at 34 weeks gestation [ Time Frame: 33 to 35 weeks gestation ]
  • Composite Neonatal Morbidity [ Time Frame: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life ]

Central Contacts and Locations

Central contacts

Ashley Battarbee, MD, MSCR

205-975-2361anbattarbee@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Ashley Battarbee

205-975-2361anbattarbee@uabmc.edu

University of California at San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Gladys Ramos, MD

858-657-7200gramos@health.ucsd.edu

University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kim Boggess, MD

919-966-2131kim_boggess@med.unc.edu

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97213

Contacts

Amy Valent, DO, MCR

503-418-4200valent@ohsu.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Celeste Durnwald, MD

800-789-7366celeste.durnwald@pennmedicine.upenn.edu

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Daniel Pasko, MD

864-455-7000daniel.pasko@prismahealth.org

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Michal Fishel Bartal, MD

832-325-7133michal.f.bartal@uth.tmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Diabetes
  • Pregnancy
  • CGM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-29.