Performance Evaluation of an Investigational Blood Glucose Monitoring System

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: CONTOUR® PLUS Investigational BG Monitoring System

• Registration Number: NCT01598610
• Lead Sponsor: Ascensia Diabetes Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-05-13
• Study First Submitted QC: 2012-05-13
• Study First Posted: 2012-05-15
• Results First Submitted: 2013-05-30
• Results First Submitted QC: 2013-05-30
• Results First Posted: 2013-07-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the Monitoring System	CONTOUR® PLUS Investigational BG Monitoring System	Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.

Primary Outcome Measures

Name	Time	Method
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	1 hour	Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

Secondary Outcome Measures

Name	Time	Method
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	1 hour	Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	1 hour	Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma) of the reference method results.
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method	1 hour	Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma) of the reference method results.
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	1 hour	Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements	1 hour	Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.

Trial Locations

Locations (2)

Midwest Institute For Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

Consumer Product Testing Co.; 🇺🇸 Fairfield, New Jersey, United States