Actively Recruiting
Continuous Glucose Monitoring for 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
N/A
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
Researchers are evaluating continuous glucose monitoring (CGM) to detect and manage high blood sugar early in pregnancy among women without diabetes carrying a single baby. The study aims to understand if early detection and management of hyperglycemia can reduce problems for the baby, such as being too large, shoulder injuries, high bilirubin needing treatment, low blood sugar, or NICU admission, and also to assess any high blood pressure issues for the mother during pregnancy. Pregnant women up to 14 weeks and 6 days of gestation will initially wear a blinded CGM sensor to screen for high blood sugar. Those who meet the study's hyperglycemia criteria will be randomized by 16 weeks and 6 days into either a Glucose Lowering group, wearing an unblinded CGM sensor continuously with nutrition and glucose management support, or a Usual Care group, receiving standard obstetrical care with periodic blinded CGM monitoring. Participants not meeting the criteria will form an observational group with ongoing monitoring. Participants will have regular visits about every 4 weeks, which may include telehealth, and weekly glucose data reviews for those in the treatment group. Researchers will assess outcomes including a combined measure of newborn complications and maternal high blood pressure up to 45 weeks of pregnancy. Safety and health will be monitored throughout, with data compared between groups to evaluate the impact of early CGM-based management.
CONDITIONS
Brief 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
- Pregnant with a single baby (singleton pregnancy)
- Gestational age up to 14 weeks and 6 days at start of screening
- HbA1c less than 6.5% (48 mmol/mol) since pregnancy began
- No prior history of gestational diabetes
- Able to read English or Spanish
You will not qualify if you...
- Signs of abnormal fetal or placental development at first prenatal visit or ultrasound
- Planned pregnancy termination or indications of miscarriage
- Prior gastric bypass surgery
- Pre-existing diabetes (type 1 or type 2) before pregnancy
- Unwilling or unable to wear continuous glucose monitoring sensor
- Unwilling to attend routine antenatal obstetric visits
- Use of corticosteroids that can raise blood sugar within 7 days before or during CGM screening (topical and inhaled corticosteroids allowed)
- Use of insulin during this pregnancy before enrollment
- Use of metformin within 1 week or GLP-1 or other weight-loss medications within 4 weeks before starting CGM screening
- Medical reasons identified by physician preventing participation
- For randomization: must meet hyperglycemia criteria on screening CGM, be randomized by 16 weeks and 6 days of pregnancy, and not be in another intervention trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 weeks and 6 days of pregnancy
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 10 days
Participants wear blinded continuous glucose monitoring (CGM) sensors to check for high blood sugar levels and determine eligibility for randomization or observational cohort.
1 to 2 visits depending on CGM data assessment
Duration - From randomization by 16 weeks and 6 days of pregnancy through pregnancy
Participants meeting hyperglycemia criteria receive diabetes management including unblinded CGM use, nutrition guidance, and glycemic management with regular follow-up visits.
Visits approximately every 4 weeks plus weekly CGM data reviews
Duration - From 18 to 45 weeks of pregnancy
Participants not meeting hyperglycemia criteria form an observational cohort and have periodic blinded CGM monitoring throughout pregnancy beginning between 18-22 weeks.
Periodic CGM sensor wear for 10-14 days every 4 weeks approximately
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
P
Paige N Miller, BS
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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