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Continuous Glucose Monitor Use in Pregnancy

RECRUITINGN/ASponsored by University of Massachusetts, Worcester
Actively Recruiting
PhaseN/A
SponsorUniversity of Massachusetts, Worcester
Started2024-05-23
Est. completion2026-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:

* 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 Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:

* 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

Conditions3

DiabetesPregnancy, High RiskType 2 Diabetes Treated With Insulin

Locations1 site

University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Gianna L Wilkie, MD508-334-4067Gianna.Wilkie@umassmemorial.org

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