Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

NCT ID: NCT00804596

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-01-31

Brief Summary

The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).

Detailed Description

The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects with diabetes

Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood.

Group Type: OTHER

Apollo Blood Glucose Monitoring System

Intervention Type: DEVICE

Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.

Interventions

Apollo Blood Glucose Monitoring System

Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.

Intervention Type: DEVICE

Other Intervention Names

Commercial name is CONTOUR® USB

Eligibility Criteria

Inclusion Criteria

• Have type 1 or type 2 diabetes
• Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
• 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
• Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Cuddihy, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

International Diabetes Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CTD-2008-18

Identifier Type: -

Identifier Source: org_study_id