Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Key facts
- Study ID
- NCT04645641
- Run by
- DexCom, Inc.
- People needed
- 150
- Starts
- 2020-10-12
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2020-11-27
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- AMCR Institute — Escondido, California, United States (enrolling)
- Barbara Davis Center — Aurora, Colorado, United States (enrolling)
- Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States (enrolling)
- Endeavor Clinical Trials — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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