Clinical trial NCT00804596: Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
Official title: Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of Participants Rated as <=3 (Comprehension of Labeling)
timeFrame: 1-2 hours
Secondary outcomes:
measure: Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Robert Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
References: