Diabetes
Conditions
Brief summary
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
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.
Interventions
Fingerstick to obtain blood sample for analysis with the Dario BGMS
DEVICEYSI Analyzer
Fingerstick to obtain blood sample for analysis with YSI
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | 6 seconds | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Dario and Yellow Springs Instrument |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Age, Continuous | 41.44 years |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
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.
Time frame: 6 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 75 mg/dl Within ±5mg/dL | 28.6 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 75 mg/dl Within ±10mg/dL | 71.4 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 75 mg/dl Within ±15mg/dL | 100 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >= 75 mg/dl Within ±5% | 32.5 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >= 75 mg/dl Within ±10% | 60.1 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >=75 mg/dl Within ±15% | 87.6 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >=75 mg/dl Within ±20% | 99.2 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 100 mg/dl Within ±5mg/dL | 28.8 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 100 mg/dl Within ±10mg/dL | 61.4 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | < 100 mg/dl Within ±15mg/dL | 97.7 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >=100 mg/dl Within ±5% | 35.7 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >=100 mg/dl Within ±10% | 65.5 percentage of participants |
| Dario Blood Glucose Monitoring System | Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) | >=100 mg/dl Within ±15% | 95.2 percentage of participants |