Recruiting

Glucose MonitorContinuous Glucose Monitor Use in Pregnancy

Sponsor:

University of Massachusetts, Worcester

Code:

NCT05317585

Conditions

Type 2 Diabetes Treated With Insulin

Pregnancy, High Risk

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Study Details

Brief 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

Study ID

NCT05317585

Start date

May 23, 2024

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Continuous Glucose Monitor

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gianna L Wilkie, MD

7743642523 Gianna.Wilkie@umassmemorial.org

Heidi Leftwich, DO

Heidi.Leftwich@umassmemorial.org

Locations

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Gianna L Wilkie, MD

508-334-4067 Gianna.Wilkie@umassmemorial.org

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

Type 2 diabetes
Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-08-03.