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NCT03087877 Clinical Trial

Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

Diabetes Mellitus Clinical Trial

Official title:
Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03087877
Other study ID # PTL902020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2017
Est. completion date March 4, 2017

Study information
Verified date December 2018
Source DexCom, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Description:

The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date March 4, 2017
Est. primary completion date March 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ages 18 or older

- Diagnosis of diabetes

Exclusion Criteria:

- Pregnancy

- Known gastroparesis

- Abnormal liver function

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Acetaminophen Challenge (G6 CGM)
Evaluation of acetaminophen effect on CGM glucose sensing

Locations
Country Name City State
United States AMCR Escondido California
United States Rainier Clinical Research Center Inc Renton Washington
United States William Sansum Diabetes Center Santa Barbara California
United States Diablo Clinical Research Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interference Effect for the G6 CGM Bias of sensor to reference measurement pre and post acetaminophen administration 6 hrs post dose
Secondary Mean of sensor minus YSI values (bias) for various time periods Bias calculated for pre-dose, post dose and peak post dose 6 hrs post dose
Secondary Duration of interference effect for the G6 CGM Length of time the inhibition effect is more than 10 mg/dL 6 hrs post dose
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