CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

May 27, 2025

Status verified

Dec 2025

Primary completion

Nov 27, 2027

Completion

Nov 27, 2027

Study Design

Enrollment

6,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Glucose Lowering Group
• Active Comparator: Usual Care Group (with periodic blinded CGM)
• No Intervention: Observational

Primary Outcome Measure

Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy [ Time Frame: Baseline to 45 weeks ]

Central Contacts

• Judy Sibayan, MPH, CCRP, Epidemiologist
  813-975-8690
  [email protected]
• Paige N Miller, BS
  813-975-8690
  [email protected]

Locations (8)

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