Continuous glucose monitoring to find and manage early high blood sugar in pregnancy
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
This uses continuous glucose monitors in early pregnancy for people without diabetes to find and treat high blood sugar and try to reduce problems for mother and baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jaeb Center for Health Research Academic / other |
| Locations | 10 sites (Birmingham, Alabama and 9 other locations) |
| Trial ID | NCT06957028 on ClinicalTrials.gov |
What this trial studies
Pregnant participants without pre-existing diabetes are enrolled by 14 weeks and 6 days and wear a blinded continuous glucose monitor for initial screening. Blinded CGM data are reviewed after 5 days and, if needed, again after 10 days to identify early hyperglycemia defined as 5% to <25% of readings over 140 mg/dL. Those who meet the hyperglycemia threshold and remain eligible are randomized by 16 weeks 6 days to a glucose-lowering intervention with visible CGM versus usual care with continued blinded monitoring, and CGM data in the treatment group are tracked over time. The trial compares maternal outcomes like hypertensive disorders and neonatal outcomes such as large-for-gestational-age infants, shoulder injuries, hypoglycemia, hyperbilirubinemia, and NICU admissions with follow-up roughly every four weeks.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a singleton pregnancy, HbA1c under 6.5%, no prior gestational diabetes, able to read English or Spanish, and enrolled by 14 weeks 6 days are the intended participants.
Not a fit: Participants who never meet the CGM hyperglycemia threshold, have multiple pregnancy, prior GDM, HbA1c ≥6.5%, or who enroll after the gestational age window are unlikely to receive the intervention or benefit.
Why it matters
Potential benefit: If successful, earlier detection and treatment of high blood sugar could lower the risk of large babies, birth injuries, neonatal complications, and pregnancy-related high blood pressure.
How similar studies have performed: Prior trials have shown CGM can improve glucose detection and short-term glycemic control in pregnancy, but evidence that early CGM-based intervention reduces clinical maternal or neonatal complications remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Maternal age of 18 years and older 2. Singleton pregnancy 3. 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 4. 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. 5. No prior history of gestational diabetes mellitus (GDM) 6. Able to read English or Spanish Exclusion Criteria 1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound 2. Planned termination of pregnancy or any indications of miscarriage 3. Prior gastric bypass surgery 4. Pregravid diabetes (type 1 or type 2) 5. Unwillingness/inability to wear CGM sensor 6. Unwillingness to attend routine antenatal obstetric appointments 7. 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 8. Use of insulin during the pregnancy prior to enrollment 9. 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 10. Deemed unable to participate for medical reasons identified by their physician Additional Criteria for RCT Eligibility 1. Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL 2. Randomization by 16 week 6 days of pregnancy 3. No participation in a separate intervention trial.
Where this trial is running
Birmingham, Alabama and 9 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Emory University — Decatur, Georgia, United States (Recruiting)
- IDC at Park Nicollet — Saint Louis Park, Minnesota, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Leeds Teaching Hospitals NHS Trust — Leeds, Leeds, United Kingdom (Not_yet_recruiting)
- Norfolk and Norwich University Hospitals NHS — Norwich, Norwich, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Judy Sibayan, MPH, CCRP, Epidemiologist
- Email: jsibayan@jaeb.org
- Phone: 813-975-8690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.