Recruiting

Continuous Glucose Monitor Use in Pregnancy

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.

ClinicalTrials.gov IDNCT05317585

PhaseNA

Enrollment180

SponsorUniversity of Massachusetts, Worcester

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk

About this study

Interventions

Device: Continuous Glucose Monitor — Continuous Glucose Monitor
Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) — Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Primary outcomes

Large for Gestational Age Infant (Within 2 hours of birth)

Eligibility information

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

Study locations

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01605 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.