The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.
The study will be performed with 50 fresh capillary blood samples, collected by fingerstick using Dario single use lancet. Additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the YSI 2300 STAT Plus analyzer. Additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
Fingerstick to obtain blood sample for analysis with the Dario BGMS
Fingerstick to obtain blood sample for analysis with YSI
Barbara Davis Center
Aurora, Colorado, United States
Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations \<75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.
Time frame: 6 seconds
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