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G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

Sponsor
DexCom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02696252
Collaborator
(none)
97
Enrollment
4
Locations
3
Duration (Months)
24.3
Patients Per Site
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
    Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Apr 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    CGM Users

    Outcome Measures

    Primary Outcome Measures

    1. proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ages 2 or older

    • Diagnosis of Type 1 diabetes or Type 2 diabetes

    • Willing to participate in a clinic session involving venous sampling for evaluation of study end point

    Exclusion Criteria:

    • Use of acetaminophen

    • Known allergy to medical-grade adhesives

    • Pregnancy

    • Hematocrit outside specification of the study-assigned blood glucose meter

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AMCR Institute Escondido California United States 92025
    2 Rocky Mountain Diabetes and Osteoporosis Center Idaho Falls Idaho United States 83404
    3 Joslin Diabetes Center Boston Massachusetts United States 02215
    4 Clinical Trials of Texas San Antonio Texas United States 78229

    Sponsors and Collaborators

    • DexCom, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DexCom, Inc.
    ClinicalTrials.gov Identifier:
    NCT02696252
    Other Study ID Numbers:
    • PTL-901800
    First Posted:
    Mar 2, 2016
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by DexCom, Inc.
    Endocrine System Diseases
    Glucose Metabolism Disorders
    Metabolic Diseases

    Study Results

    No Results Posted as of Apr 14, 2016