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CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

ConditionGestational Diabetes Mellitus in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJaeb Center for Health Research

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Maternal age of 18 years and older

Singleton pregnancy

Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening

HbA1c <6.5% (48 mmol/mol) since onset of pregnancy

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diabetes Treatment

    Other intervention

    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.

  • Usual Care Group

    Other intervention

    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.

Treatment groups

6,000 Participants
are divided into 3 treatment groups
Group A: Glucose Lowering GroupExperimental treatment 1 intervention
Group B: Usual Care Group (with periodic blinded CGM)Active comparator 1 intervention
Group C: ObservationalNo intervention 0 interventions

Trial outcomes

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) .

Time frame
Baseline to 45 weeks

Secondary outcomes

1

Composite of Neonatal Complications, Death, and Maternal Complications

* Composite of neonatal complications * Individual maternal and neonatal complications * Neonatal death

Time frame
Baseline to 45 weeks

Other outcomes

1

Small for Gestational Age Birth Weight

Small for gestational age birth weight (\&lt;10th percentile)

Time frame
Baseline to 45 weeks
2

CGM-Measured Time Less Than 54 mg/dL

CGM-measured time less than 54 mg/dL (during comparative periods where Usual Care group has blinded CGM)

Time frame
Through study completion, an average of 30 months
3

Severe Hypoglycemia Events

Severe Hypoglycemia Events

Time frame
Through study completion, an average of 30 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

DexCom, Inc.

Collaborator

Abbott

Collaborator

Source ClinicalTrials.gov
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