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Continuous Glucose Monitor Use in Pregnancy for Type 2 Diabetes

This study is for pregnant women with type 2 diabetes (T2DM) who are treated with insulin and are at high risk. It compares using a Continuous Glucose Monitor (CGM) to the usual method of checking blood sugar with fingersticks. The goal is to see if using a CGM can reduce the number of babies born 'Large for Gestational Age' (larger than average for their age), improve blood sugar control for the mother, and increase patient satisfaction. You may be able to join if you are at least 18 years old, less than 14 weeks pregnant with one baby, and have a confirmed diagnosis of T2DM. The study aims to enroll 180 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two different ways to monitor blood sugar in 180 pregnant women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, 'Large for Gestational Age Infant,' is measured within 2 hours of birth.

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NCT05317585

Continuous Glucose Monitor Use in Pregnancy

Recruiting
NAAges 18+InterventionalPrevention
University of Massachusetts, Worcester
~180 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Continuous Glucose MonitorRoutine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Large for Gestational Age Infant
Measured over Within 2 hours of birth

Conditions

Type 2 Diabetes Treated With Insulin
Pregnancy, High Risk

Explore related trials

PregnancyType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

Gianna L Wilkie, MD
[email protected]
7743642523
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Eligibility criteria

Inclusion

1\) age greater than or equal to 18 years old
2\) singleton gestation less than or equal to 14 weeks at initial obstetric visit
3\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
4\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
5\) able and willing to provide informed consent

Exclusion

1\) known diagnosis of type 1 diabetes or gestational diabetes
2\) plan to receive prenatal care or delivery outside of UMMHC
3\) inability to provide informed consent
4\) multifetal gestation

What this trial measures

  • Large for Gestational Age InfantWithin 2 hours of birth

    The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.