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A New Glucose Meter With Alternative Site Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797212
First Posted: November 25, 2008
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ascensia Diabetes Care
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Ascensia Diabetes Care:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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:

    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 ]
    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 Apollo 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797212


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

Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT00797212     History of Changes
Other Study ID Numbers: CTD-2008-19
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: November 12, 2009
Results First Posted: December 14, 2009
Last Update Posted: November 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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