Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
1 other identifier
interventional
150
1 country
4
Brief Summary
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Oct 2020
Shorter than P25 for not_applicable diabetes-mellitus
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2020
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 27, 2020
November 1, 2020
2 months
November 2, 2020
November 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
System Performance
System Performance will be characterized with respect to comparator venous plasma measurements.
10 days
Secondary Outcomes (1)
System Related Adverse Device Effects
10 days
Study Arms (1)
CGM Users
ACTIVE COMPARATORGlucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.
Interventions
Eligibility Criteria
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%;
- years of age: 35.0%;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (4)
AMCR Institute
Escondido, California, 92025, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 82404, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by study staff.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 27, 2020
Study Start
October 12, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 27, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share