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Completed

NCT Number: NCT00797563

Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.

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Key information

Conditions

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

Consumer Product Testing Co., Inc.

Fairfield, New Jersey, 07004, United States

About this study

The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.

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 > 18, < 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
  • 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

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 (81 mg 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 use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).

Other names: CONTOUR® USB

Primary outcomes

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

    Time frame: One hour

    Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.

Secondary outcomes

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

    Time frame: One hour

    Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:

    • Successful
    • Successful after being referred to user instructions
    • Successful with 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.)

  2. Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter

    Time frame: One hour

    Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 25, 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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