Diabetes Mellitus
Conditions
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.
Interventions
Dexcom Continuous Glucose Monitoring System
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dexcom Continuous Glucose Monitoring System Performance | 10 days | The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Related Adverse Device Effects | 10 days | The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants |
Countries
United States
Outcome results
None listed