A New Glucose Meter With Alternative Site Testing

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes	Apollo Blood Glucose Monitoring System	Subjects with diabetes use a new Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm

Primary Outcome Measures

Name	Time	Method
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results	One hour	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

Secondary Outcome Measures

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