CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

ID#: NCT06957028

Age: 18 years - 66+

Gender: Female

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 27, 2025

End Date: November 27, 2027

Contact Information:
Judy Sibayan, MPH, CCRP, Epidemiologist
813-975-8690
Paige N Miller, BS
813-975-8690
Summary: 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.
Eligibility: 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.
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