NCT06957028 · Jaeb Center for Health Research
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
- Planned termination of pregnancy or any indications of miscarriage
- Prior gastric bypass surgery
- Pregravid diabetes (type 1 or type 2)
- Unwillingness/inability to wear CGM sensor
- Unwillingness to attend routine antenatal obstetric appointments
- Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening • Topical and inhaled corticosteroids are acceptable
- Use of insulin during the pregnancy prior to enrollment
- Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
- Deemed unable to participate for medical reasons identified by their physician Additional Criteria for RCT Eligibility
- Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL
- Randomization by 16 week 6 days of pregnancy
- No participation in a separate intervention trial.
Where
- Birmingham, Alabama
- Miami, Florida
- Decatur, Georgia
- Saint Louis Park, Minnesota
- New York, New York
- Cleveland, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations