N/A N=220 Diagnostic

Performance Evaluation of an Investigational Blood Glucose Monitoring System

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01598610 ↗

Enrolled (actual)

220

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method — 100 percentage of BG Test Results

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CONTOUR® PLUS Investigational BG Monitoring System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ascensia Diabetes Care
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	100	—
SECONDARY Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	98.1	—
SECONDARY Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	99.5	—
SECONDARY Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method	98.2; 93.5; 86.1; 53.7	—
SECONDARY Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff	99.5	—
SECONDARY Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements	215; 220; 218; 218; 218; 218	—

Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Eligibility Criteria

Inclusion Criteria

Males and females, 18 years of age and older
Type 1 or type 2 diabetes
Able to speak, read, and understand English
Willing to complete all study procedures

Exclusion Criteria

Pregnancy
Hemophilia or any other bleeding disorder
Previously participated in a study using the CONTOUR PLUS system
Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01598610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.