RECRUITING

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

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

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Official Title

Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus

Quick Facts

Study Start:2024-10-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06184373

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 to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with a viable singleton intrauterine pregnancy
  2. * Able to understand the study, and having understood, provide written informed consent in English
  3. * Recent pregnancy affected by gestational diabetes
  1. * Pregestational Diabetes (Type I or Type II)
  2. * Continued use of diabetes medications (including metformin and insulin) immediately after delivery
  3. * Preterm delivery (\< 37 weeks gestation)
  4. * Twin or higher order gestation
  5. * No access to a smartphone
  6. * Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
  7. * Participation in this trial in a prior pregnancy
  8. * History of skin allergy to adhesive products or CGM

Contacts and Locations

Study Contact

Rachel Gordon, MD, MPH
CONTACT
614-293-7980
rachel.gordon@osumc.edu
Seuli Brill, MD
CONTACT
614-293-7980
seuli.brill@osumc.edu

Study Locations (Sites)

Ohio State University Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

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 Date2024-10-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Diabetes
  • Hyperglycemia