Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00804596
First received: December 5, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).


Condition Intervention
Diabetes
Device: Apollo 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: Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Rated as <=3 (Comprehension of Labeling) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:

    1. Successful in performing tasks correctly without assistance
    2. Successful after being referred to user instructions
    3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
    4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)


Secondary Outcome Measures:
  • Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.


Enrollment: 74
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood.
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.
Other Name: Commercial name is CONTOUR® USB

Detailed Description:

The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 1 or type 2 diabetes
  • Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
  • Be willing to complete all study procedures
  • Be routinely testing their blood sugar at home (at least once per day)
  • Be able to speak, read, and understand English and understand the Informed Consent document
  • Be able to read the labeling instructions
  • Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.

Exclusion Criteria:

  • Minors <18 years of age and adults >75 years of age
  • Pregnancy
  • Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
  • Disorders in the fingertip lancing areas
  • Acute or chronic infections, particularly skin infections
  • Infection with a blood borne pathogen
  • Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion
  • Hemophilia or any other bleeding disorder
  • Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
  • Working for a competitive medical device company
  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: NCT00804596

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Robert Cuddihy, MD International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00804596     History of Changes
Other Study ID Numbers: CTD-2008-18
Study First Received: December 5, 2008
Results First Received: December 16, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014