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CGM for Management of Type 2 Diabetes in Pregnancy

NCT06628453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2025-06-15

No results posted yet for this study

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

Interventions

DEVICE

CGM

Real-time continuous glucose monitoring

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ashley Battarbee, MD, MSCR · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2029-02-28
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628453 on ClinicalTrials.gov