Status:
COMPLETED
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Lead Sponsor:
University of Washington
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestatio...
Detailed Description
Pregnant Participants diagnosed with gestational diabetes are being invited to take part in a research study because these participants are pregnant and have gestational diabetes. Participants will be...
Eligibility Criteria
Inclusion
- Pregnancy and Gestation \< 30 weeks
- Singleton pregnancy
- Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
- Able to read English and completed 6th grade
- Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), communicate with the investigator, and understand and comply with protocol requirements
Exclusion
- Pre-gestational Type 1 or Type 2 diabetes.
- Newly diagnosed overt-diabetes in pregnancy \[HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l\].
- Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
- Known endogenous/exogenous Cushing's syndrome
- Known chronic infections
- Current use of any oral form of steroid medication
- Already receiving continuous glucose monitoring (CGM)
- History of bariatric surgery
- Gestational Age less than 14 weeks -
Key Trial Info
Start Date :
April 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04803357
Start Date
April 10 2021
End Date
January 15 2025
Last Update
June 25 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98109