Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01575080
First received: April 9, 2012
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.


Condition Intervention
Diabetes
Device: Contour TS Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).


Secondary Outcome Measures:
  • Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).

  • Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).

  • Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.


Enrollment: 102
Study Start Date: April 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Device: Contour TS Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of diabetes
  • Be 18 years of age or older
  • Be able to speak, read and understand English and understand the Informed Consent document.
  • Be willing to complete study procedures

Exclusion Criteria:

  • Pregnancy
  • Infections or skin disorders at the puncture site (at the discretion of the site professional staff).
  • Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
  • Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
  • A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
  • Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.
  • 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
  • Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575080

Locations
United States, Indiana
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: David Simmons, MD Bayer HealthCare, Diabetes Care
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01575080     History of Changes
Other Study ID Numbers: R&D-2011-2012-0.20
Study First Received: April 9, 2012
Results First Received: April 26, 2013
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014