Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus	Device: Apollo Blood Glucose Monitoring System

Study Type:	Interventional
Study Design:	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 Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: One hour ] [ Designated as safety issue: No ]
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 Outcome Measures:

Percentage of Participants Rated as <=3 (Labeling Comprehension) [ Time Frame: One hour ] [ Designated as safety issue: No ]
Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. 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.)
Number of Partipants Who Gave These 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 Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).

Enrollment:	102
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 (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.	Device: Apollo Blood Glucose Monitoring System 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 Name: CONTOUR® USB

Detailed Description:

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797563

Locations

United States, New Jersey
Consumer Product Testing Co., Inc.
Fairfield, New Jersey, United States, 07004

Sponsors and Collaborators

Bayer HealthCare, Diabetes Care

Investigators

Principal Investigator:

Joy Frank, RN

Consumer Product Testing Co., Inc.

More Information

No publications provided

Responsible Party:	Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:	NCT00797563 History of Changes
Other Study ID Numbers:	CTD-2008-17
Study First Received:	November 24, 2008
Results First Received:	November 17, 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 22, 2013