Continuous Glucose Monitor Use in Pregnancy

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT05317585
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitor — DEVICE
    Continuous Glucose Monitor
  • Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) — DEVICE
    Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Study Details

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.

Key Dates

Start date
May 23, 2024
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Continuous Glucose Monitoring (CGM)
    Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.
  • Active Comparator: Fingerstick Glucose Monitoring
    Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.

Primary Outcome Measure

Large for Gestational Age Infant [ Time Frame: Within 2 hours of birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01605
Gianna L Wilkie, MD
[email protected]
508-334-4067

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By research site
University of Massachusetts Memorial Medical Center· Worcester, MA

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