Status:
RECRUITING
Continuous Glucose Monitor Use in Pregnancy
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Type 2 Diabetes Treated With Insulin
Pregnancy, High Risk
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ca...
Detailed Description
A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05317585
Start Date
May 23 2024
End Date
July 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605