Continuous glucose monitoring to find and manage early high blood sugar in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Judy Sibayan, MPH, CCRP, Epidemiologist
• Email: jsibayan@jaeb.org
• Phone: 813-975-8690

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prenatal Exercise to See How Cardio or Strength Training Affects Blood Sugar

  This study tests whether different types and amounts of exercise during pregnancy can improve blood sugar control in women with gestational diabetes.

  Recruiting University of Central Arkansas · Conway, Arkansas · NCT07802262

• Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes

  This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.

  Recruiting University of Tennessee Graduate School of Medicine · Knoxville, Tennessee · NCT07565727

• Behavioral toolkit to help pregnant women manage gestational diabetes and pregnancy-related high blood pressure.

  This program will test whether a structured behavioral toolkit helps pregnant women with both gestational diabetes and pregnancy-induced high blood pressure better control their blood sugar and blood pressure.

  Recruiting at 2 sites University of the Punjab · Lahore, Punjab Province and 1 other locations · NCT07551011

• Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study

  This study tests whether daily patterns like sleep, activity, and meal timing in early pregnancy affect glucose levels and the risk of gestational diabetes, using CGM and wearable data in pregnant women in Singapore.

  Recruiting KK Women's and Children's Hospital · Singapore, Singapore · NCT07534670

• Using a 24-hour continuous glucose monitor after delivery to predict future Type 2 diabetes risk in people with gestational diabetes

  This pilot tests whether wearing a continuous glucose monitor for 24 hours immediately after delivery can help predict later Type 2 diabetes risk in people who had gestational diabetes.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07449039

• Predicting gestational diabetes in early pregnancy using continuous glucose monitoring.

  This study is testing if using continuous glucose monitoring in early pregnancy can help identify women at risk for gestational diabetes sooner than usual.

  Recruiting Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · El Palmar, Murcia · NCT06874907

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.