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

November 24, 2008
January 26, 2012
November 2008
November 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00797212 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
A New Glucose Meter With Alternative Site Testing
Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus
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
Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
Intervention: Device: Apollo Blood Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797212
CTD-2008-19
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: Vimala Sethy, MD, PhD Jasper Clinic, Inc.
Bayer HealthCare, Diabetes Care
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP