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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Women with a viable singleton intrauterine pregnancy

• Able to understand the study, and having understood, provide written informed consent in English

• Recent pregnancy affected by gestational diabetes

Locations
United States
Ohio
Ohio State University Medical Center
RECRUITING
Columbus
Contact Information
Primary
Rachel Gordon, MD, MPH
rachel.gordon@osumc.edu
614-293-7980
Backup
Seuli Brill, MD
seuli.brill@osumc.edu
614-293-7980
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Participants
Participants will be recruited at 6-8 weeks postpartum; at that appointment, CGMs will be placed. After wearing the CGM, participants will fill out surveys regarding their experience. At 10-12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience. At 12 months postpartum, they will complete a blood test to check their hemoglobin A1c.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov