Single arm study Blood Glucose Monitoring System Altitude Performance

Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).

A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes.

1. Age of subject is 18 years or older
2. Able to speak and read English

The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).

Each subject will be measured 9 times with the Dario system: 3 strips lots for each of the three representative smart mobile devices (total of nine meters) under evaluation (150 strips per mobile device, total no. of strips 450).

Single arm study Blood Glucose Monitoring System Altitude Performance

Blood Glucose Monitoring System Altitude Performance: Performance as assessed against a reference method at an altitude of approximately 10,000 feet.