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Continuous Glucose Monitor Use in Pregnancy

NCT05317585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-01

No results posted yet for this study

Summary

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Conditions

  • Type 2 Diabetes Treated With Insulin
  • Pregnancy, High Risk

Interventions

DEVICE

Continuous Glucose Monitor

Continuous Glucose Monitor

DEVICE

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Gianna L Wilkie, MD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2026-07-01
Completion
2027-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317585 on ClinicalTrials.gov