Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Protocol for the Evaluation of Dario™ Blood Glucose Monitor (BGMS) Performance at Elevated Altitude

Conditions
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Diabetes

Intervention / Treatment
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* Device: Dario Blood Glucose Monitoring System
* Device: YSI Analyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of subject is 18 years or older Able to speak and read English Exclusion Criteria: Pregnant Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dario Blood Glucose Monitoring System<br>Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System | Device: Dario Blood Glucose Monitoring System<br>* Fingerstick to obtain blood sample for analysis with the Dario BGMS<br>|
| Active Comparator: YSI STAT<br>Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System | Device: YSI Analyzer<br>* Fingerstick to obtain blood sample for analysis with YSI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 seconds |