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Completed

NCT Number: NCT00804596

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

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).

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apollo Blood Glucose Monitoring System

Device

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 names: Commercial name is CONTOUR® USB

Primary outcomes

  1. Percentage of Participants Rated as <=3 (Comprehension of Labeling)

    Time frame: 1-2 hours

    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:

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

Secondary outcomes

  1. Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method

    Time frame: 1-2 hours

    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.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 9, 2008
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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