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

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ClinicalTrials.gov Identifier: NCT02696252
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

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

Condition or disease
Diabetes Mellitus

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.

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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 : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Group/Cohort
CGM Users



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 [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and pediatrics with diabetes mellitus
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696252


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92025
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
DexCom, Inc.

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Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT02696252     History of Changes
Other Study ID Numbers: PTL-901800
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by DexCom, Inc.:
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases