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Search / Trial NCT05317585

Continuous Glucose Monitor Use in Pregnancy

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Apr 6, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Type 2 Diabetes Pregnancy

ClinConnect Summary

This clinical trial is looking at how effective a Continuous Glucose Monitor (CGM) is for pregnant women with type 2 diabetes compared to the usual method of checking blood sugar with fingersticks. The study aims to see if using a CGM can help with managing blood sugar levels, improve satisfaction for women during pregnancy, and reduce the risk of having larger babies or other complications. They are recruiting 180 women who are at high risk due to their diabetes.

To participate, women need to be at least 18 years old and in their first trimester of pregnancy (less than 14 weeks along) with a confirmed diagnosis of type 2 diabetes. It’s important that they plan to receive their prenatal care at UMASS Memorial Health Care and can provide consent to join the study. If selected, participants will use the CGM, which continuously tracks their blood sugar levels, and will have regular check-ins with the healthcare team to monitor their health and the health of their baby throughout the pregnancy.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:
  • 1) age greater than or equal to 18 years old
  • 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit
  • 3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
  • 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
  • 5) able and willing to provide informed consent
  • Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:
  • 1) known diagnosis of type 1 diabetes or gestational diabetes
  • 2) plan to receive prenatal care or delivery outside of UMMHC
  • 3) inability to provide informed consent
  • 4) multifetal gestation

About University Of Massachusetts, Worcester

The University of Massachusetts Worcester is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the university integrates cutting-edge scientific inquiry with a commitment to improving patient outcomes. Its collaborative approach engages a diverse range of experts, fostering interdisciplinary research that addresses pressing health challenges. With a focus on ethical standards and regulatory compliance, the University of Massachusetts Worcester plays a pivotal role in translating scientific discoveries into practical applications that enhance medical practice and patient care.

Locations

Worcester, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Gianna L Wilkie, MD

Principal Investigator

University of Massachusetts, Worcester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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