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Completed

NCT Number: NCT00797212

A New Glucose Meter With Alternative Site Testing

The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

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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

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

About this study

The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

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 years 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 (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 use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.

Other names: Commercial name is CONTOUR® USB

Primary outcomes

  1. Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results

    Time frame: One hour

    Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP

Secondary outcomes

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

    Time frame: One hour

    Study staff rated participants as to their success at performing meter testing. 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. Percentage of Participant 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 Monitor 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 Alternative Site Testing [Commercial Name is CONTOUR® USB]

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 25, 2008
Registry last updated
Nov 3, 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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