CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Launched by JAEB CENTER FOR HEALTH RESEARCH · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how continuous glucose monitoring (CGM) can help detect and manage high blood sugar levels in pregnant women early in their pregnancies. It aims to understand if using CGM can prevent problems for the baby, such as being born larger than expected or needing extra medical care after birth, as well as high blood pressure issues for the mother during pregnancy.

To be eligible for the trial, participants need to be women aged 18 or older who are having a single pregnancy and are up to 14 weeks and 6 days along. They should not have had diabetes before becoming pregnant and should have a normal blood sugar level. Participants will wear a CGM device to track their blood sugar levels and will attend regular check-ups. The trial is not yet recruiting, so interested individuals will need to wait for it to begin. This study is important because it could lead to better management of blood sugar levels in pregnancy, benefiting both mothers and their babies.

Gender

FEMALE

Eligibility 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.