A New Glucose Meter With Alternative Site Testing

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Apollo Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm | Device: Apollo Blood Glucose Monitoring System<br>* 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.<br>* Other names: Commercial name is CONTOUR® USB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results | 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 | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Rated as <=3 (Labeling Comprehension) | Study staff rated participants as to their success at performing meter testing. 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 | 
| Percentage of Participant Ratings for Overall Testing Experience With This Meter | 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). | One hour |