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Search / Trial NCT06628453

CGM for Management of Type 2 Diabetes in Pregnancy

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Oct 3, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Diabetes Pregnancy Cgm

ClinConnect Summary

This clinical trial is exploring whether continuous glucose monitoring (CGM) is more effective than the traditional method of checking blood sugar levels with fingersticks for managing type 2 diabetes during pregnancy. The study aims to find out if using CGM helps improve the health outcomes of both mothers and their babies. It will also look at other factors that might increase the risk of complications for both mothers and infants in pregnancies complicated by type 2 diabetes.

To participate in this trial, women aged 18 to 50 who have type 2 diabetes and are pregnant with a viable fetus between 6 and 23 weeks of gestation may be eligible. Throughout the study, participants will either use CGM or continue with fingerstick monitoring until delivery. They will also provide blood samples at different stages of pregnancy and complete surveys about their support systems and feelings related to diabetes management. Additionally, umbilical cord blood will be collected at delivery for further research. This trial is not yet recruiting participants, but it represents an important step in understanding how to better manage diabetes in pregnancy for improved outcomes.

Gender

FEMALE

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

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Philadelphia, Pennsylvania, United States

Birmingham, Alabama, United States

Houston, Texas, United States

Chapel Hill, North Carolina, United States

Greenville, South Carolina, United States

San Diego, California, United States

Portland, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Ashley Battarbee, MD, MSCR

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported