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NCT02696252 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02696252
Other study ID # PTL-901800
Secondary ID
Status Completed
Phase N/A
First received January 25, 2016
Last updated April 13, 2016
Start date January 2016
Est. completion date April 2016

Study information
Verified date April 2016
Source DexCom, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Joslin Diabetes Center Boston Massachusetts
United States AMCR Institute Escondido California
United States Rocky Mountain Diabetes and Osteoporosis Center Idaho Falls Idaho
United States Clinical Trials of Texas San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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