Actively Recruiting
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Led by Jaeb Center for Health Research · Updated on 2025-12-23
6000
Participants Needed
10
Research Sites
130 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age of 18 years and older
- Singleton pregnancy
- Gestational age up to 14 weeks 6 days for starting screening
- HbA1c less than 6.5% (48 mmol/mol) since pregnancy began
- No prior history of gestational diabetes mellitus
- Able to read English or Spanish
- Screening CGM showing 5% to less than 25% of values over 140 mg/dL
- Randomization by 16 weeks 6 days of pregnancy
- No participation in another intervention trial
You will not qualify if you...
- Signs of abnormal fetal or placental development at first prenatal visit or ultrasound
- Planned pregnancy termination or any signs of miscarriage
- Prior gastric bypass surgery
- Pre-existing diabetes (type 1 or type 2)
- Unwillingness or inability to wear CGM sensor
- Unwillingness to attend routine prenatal appointments
- Use of corticosteroids that can raise blood sugar within 7 days before or during CGM screening (topical and inhaled corticosteroids allowed)
- Use of insulin before enrollment during pregnancy
- Use of metformin within 1 week or GLP-1 or other weight-loss medicines within 4 weeks before CGM screening
- Deemed unable to participate due to medical reasons by their doctor
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35173
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33016
Actively Recruiting
3
Emory University
Decatur, Georgia, United States, 30033
Actively Recruiting
4
IDC at Park Nicollet
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Leeds Teaching Hospitals NHS Trust
Leeds, Leeds, United Kingdom
Not Yet Recruiting
10
Norfolk and Norwich University Hospitals NHS
Norwich, Norwich, United Kingdom
Not Yet Recruiting
Research Team
J
Judy Sibayan, MPH, CCRP, Epidemiologist
CONTACT
P
Paige N Miller, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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