Type 2 Diabetes (T2D) Clinical Trials

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Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
University of Massachusetts Memorial Medical Center
RECRUITING
Worcester
Contact Information
Primary
Gianna L Wilkie, MD
Gianna.Wilkie@umassmemorial.org
7743642523
Backup
Heidi Leftwich, DO
Heidi.Leftwich@umassmemorial.org
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 180
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov