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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dario Blood Glucose Monitoring System | Experimental | Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System |
|
| YSI STAT | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dario Blood Glucose Monitoring System | Device | Fingerstick to obtain blood sample for analysis with the Dario BGMS |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christie Beatson | Barbara Davis Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
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52 subjects - two blood glucose assessment types each (Dario vs YSI). Totaling 104 samples of blood for with 312 data points generated across 6 Dario meters and 1 YSI assessment per subject (52 total YSI assessments).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dario and Yellow Springs Instrument | Blood is obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System, blood glucose level is then also analyzed on the Yellow Springs Instrument for comparison. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dario and Yellow Springs Instrument | Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 6 seconds |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dario Blood Glucose Monitoring System | Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Satish K. Garg | Barbara Davis Center for Childhood Diabetes | 303-724-6761 | satish.garg@ucdenver.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| YSI Analyzer | Device | Fingerstick to obtain blood sample for analysis with YSI |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | YSI STAT | 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 YSI Analyzer: Fingerstick to obtain blood sample for analysis with YSI | 0 | 52 | 0 | 52 |
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