Status:
COMPLETED
Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
Lead Sponsor:
DexCom, Inc.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Detailed Description
The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
Eligibility Criteria
Inclusion
- Ages 2 or older
- Diagnosis of Type 1 diabetes or Type 2 diabetes
- Willing to wear the required number of Systems for the total duration of study wear
- Willing to participate in Clinic Session(s) during study wear
Exclusion
- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification
- ≥ 18 years of age:
- Male: 36.0%;
- Female: 33.0%;
- 13-17 years of age: 35.0%;
- 7 years - 12 years of age: 32.0%;
- End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
- Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT04794478
Start Date
February 19 2021
End Date
October 31 2021
Last Update
February 18 2022
Active Locations (12)
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1
ProSciento
Chula Vista, California, United States, 91911
2
AMCR Institute
Escondido, California, United States, 92025
3
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
4
Diablo Clinical Research
Walnut Creek, California, United States, 94598