RECRUITING

Continuous Glucose Monitor Use in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Official Title

Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Quick Facts

Study Start:2024-05-23
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05317585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Gianna L Wilkie, MD
CONTACT
7743642523
Gianna.Wilkie@umassmemorial.org
Heidi Leftwich, DO
CONTACT
Heidi.Leftwich@umassmemorial.org

Principal Investigator

Gianna L Wilkie, MD
PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester

Study Locations (Sites)

University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Gianna L Wilkie, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-23
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2024-05-23
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Type 2 diabetes
  • Pregnancy

Additional Relevant MeSH Terms

  • Type 2 Diabetes Treated With Insulin
  • Pregnancy, High Risk