Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Apollo Blood Glucose Monitoring System


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with diabetes<br>Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. | Device: Apollo Blood Glucose Monitoring System<br>* 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).<br>* Other names: CONTOUR® USB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | 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. | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Rated as <=3 (Labeling Comprehension) | Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was: Successful Successful after being referred to user instructions Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) | One hour | 
| Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 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). | One hour |