RecruitingNot ApplicableNCT06957028

CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Sponsor

Jaeb Center for Health Research

Enrollment

6,000 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Gestational Diabetes Mellitus in Pregnancy

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria15

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.

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Interventions

OTHERDiabetes Treatment

Management will include an unblinded CGM sensor worn 24/7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg/dL \[3.5-7.8 mmol/L\]). Visits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data by site and by central CGM Resource Center for flagged cases. Participants not receiving glucose lowering medication by 24-28 weeks will undergo OGTT per usual obstetrical management and those with positive OGTT will be treated for GDM per usual clinic routine and continue to wear an unblinded CGM.

OTHERUsual Care Group

The control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation. At 18-22 weeks, blinded CGM data will be reviewed to assess if participant has ≥25% time \>140 mg/dL to determine if an early OGTT or glycemic management is required. Site clinicians will be unblinded to the masked CGM data for participants with CGM data ≥25% time \>140 mg/dL and those participants may be treated as those with a positive OGTT. An OGTT will be performed at \~24-28 weeks per the clinic's usual routine and those with positive OGTT will be treated for GDM per usual clinic routine. If real-time CGM is to be used, then unblinded study CGM sensors can be used instead of blinded sensors for the duration of the study.