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A New Glucose Meter With Alternative Site Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00797212
First received: November 24, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention
Diabetes Mellitus
 Device: Apollo Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants Rated as <=3 (Labeling Comprehension) [ Time Frame: One hour ] [ Designated as safety issue: No ]

    Study staff rated participants as to their success at performing meter testing. The rating scale was:

    1. Successful
    2. Successful after being referred to user instructions
    3. Successful with 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.)

  • Percentage of Participant Ratings for Overall Testing Experience With This Meter [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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).


Enrollment: 50
Study Start Date: November 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (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 blood obtained from the palm and forearm
 Device: Apollo Blood Glucose Monitoring System
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 Name: Commercial name is CONTOUR® USB

Detailed Description:

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.

  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 >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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797212

Locations
United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Vimala Sethy, MD, PhD Jasper Clinic, Inc.
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00797212     History of Changes
Other Study ID Numbers: CTD-2008-19
Study First Received: November 24, 2008
Results First Received: November 12, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013