CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.

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

• Maternal age of 18 years and older

• Singleton pregnancy

• Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening

• • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available

• HbA1c \<6.5% (48 mmol/mol) since onset of pregnancy

• • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.

• No prior history of gestational diabetes mellitus (GDM)

• Able to read English or Spanish

Locations
United States
Alabama
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Florida
University of Miami
RECRUITING
Miami
Georgia
Emory University
RECRUITING
Decatur
Minnesota
IDC at Park Nicollet
RECRUITING
Saint Louis Park
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Other Locations
United Kingdom
Leeds Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Leeds
Norfolk and Norwich University Hospitals NHS
NOT_YET_RECRUITING
Norwich
Contact Information
Primary
Judy Sibayan, MPH, CCRP, Epidemiologist
jsibayan@jaeb.org
813-975-8690
Backup
Paige N Miller, BS
pmiller@jaeb.org
813-975-8690
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2027-11-27
Participants
Target number of participants: 6000
Treatments
Experimental: Glucose Lowering Group
Active_comparator: Usual Care Group (with periodic blinded CGM)
No_intervention: Observational
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, DexCom, Inc., Abbott
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov