Performance Evaluation of an Investigational Blood Glucose Monitoring System

Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: CONTOUR® PLUS Investigational BG Monitoring System

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • New Jersey
    • Fairfield, New Jersey, United States, 07004
      • Consumer Product Testing Co.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intended Users of the Monitoring System; Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.	Device: CONTOUR® PLUS Investigational BG Monitoring System; Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 hour
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	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.	1 hour
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method	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.	1 hour
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	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.	1 hour
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements	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'.	1 hour

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Michael Caswell, PhD, Consumer Product Testing Co.; Principal Investigator: Phillip D Toth, MD, FACP, Midwest Institute for Clinical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 13, 2012
• First Submitted That Met QC Criteria: May 13, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CTD-2012-002-01