CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

NCT06957028 | Recruiting DMC

• 1 other identifier: IMAGINE
• Study Type: interventional
• Target: 6,000
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

GDM; CGM; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy

  Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) .

  Baseline to 45 weeks

Secondary Outcomes (1)

• Composite of Neonatal Complications, Death, and Maternal Complications

  Baseline to 45 weeks

Other Outcomes (3)

• Small for Gestational Age Birth Weight

  Baseline to 45 weeks

• CGM-Measured Time Less Than 54 mg/dL

  Through study completion, an average of 30 months

• Severe Hypoglycemia Events

  Through study completion, an average of 30 months

Study Arms (3)

Glucose Lowering Group

EXPERIMENTAL

Other: Diabetes Treatment

Usual Care Group (with periodic blinded CGM)

ACTIVE COMPARATOR

Other: Usual Care Group

Observational

NO INTERVENTION

Interventions

Diabetes Treatment OTHER

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.

Also known as: Continuous Glucose Monitoring

Glucose Lowering Group

Usual Care Group OTHER

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.

Also known as: Blinded Continuous Glucose Monitoring

Usual Care Group (with periodic blinded CGM)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women of child bearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DexCom, Inc.: collaborator
• Abbott: collaborator
• Jaeb Center for Health Research: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35173, United States

RECRUITING

University of Miami

Miami, Florida, 33016, United States

RECRUITING

Emory University

Decatur, Georgia, 30033, United States

RECRUITING

IDC at Park Nicollet

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, 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

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Celeste Durnwald, MD

  University of Pennsylvania

  STUDY CHAIR

Central Study Contacts

Judy Sibayan, MPH, CCRP, Epidemiologist

CONTACT

813-975-8690; jsibayan@jaeb.org

Paige N Miller, BS

CONTACT

813-975-8690; pmiller@jaeb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are initially masked from glucose results from continuous glucose monitoring.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 4, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): November 27, 2027
• Study Completion (Estimated): November 27, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (8); GB (2)