Status:
UNKNOWN
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Lead Sponsor:
DexCom, Inc.
Conditions:
Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Brief Summary
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Confirmed pregnancy
- Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
- Willing to wear up to the required number of Systems for the total duration of study wear
- Able to follow study procedures;
- Able to speak, read, and write in English or Spanish.
Exclusion
- Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
- Known allergy to medical-grade adhesives
- Hematocrit outside specification
- Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
- Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
- Currently using Hydroxyurea for treatment
- Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
Key Trial Info
Start Date :
July 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04905628
Start Date
July 8 2021
End Date
April 15 2022
Last Update
February 21 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
2
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
3
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029