Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
1 other identifier
interventional
482
1 country
12
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 P75+ for not_applicable diabetes-mellitus
Started Feb 2021
Shorter than P25 for not_applicable diabetes-mellitus
12 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
February 19, 2021
CompletedFirst Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedFebruary 18, 2022
February 1, 2022
6 months
March 2, 2021
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dexcom Continuous Glucose Monitoring System Performance
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) 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
Dexcom Continuous Glucose Monitoring System
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 (12)
ProSciento
Chula Vista, California, 91911, United States
AMCR Institute
Escondido, California, 92025, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 82404, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Advanced Research
Ogden, Utah, 84405, United States
UVA Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Related Publications (2)
Laffel LM, Bailey TS, Christiansen MP, Reid JL, Beck SE. Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 Jul;17(4):962-967. doi: 10.1177/19322968221091816. Epub 2022 Apr 25.
PMID: 35466707DERIVEDGarg SK, Kipnes M, Castorino K, Bailey TS, Akturk HK, Welsh JB, Christiansen MP, Balo AK, Brown SA, Reid JL, Beck SE. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):373-380. doi: 10.1089/dia.2022.0011. Epub 2022 Feb 21.
PMID: 35157505DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 subjects and/or caregivers.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 12, 2021
Study Start
February 19, 2021
Primary Completion
August 9, 2021
Study Completion
October 31, 2021
Last Updated
February 18, 2022
Record last verified: 2022-02