An interventional study of Dario Blood Glucose Monitoring System and YSI Analyzer in Diabetes, sponsored by LabStyle Innovations Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-09.
Sponsored by LabStyle Innovations Ltd. · Not applicable, Interventional, and Other
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.
LabStyle Innovations Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
Device: Dario Blood Glucose Monitoring System
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
Fingerstick to obtain blood sample for analysis with the Dario BGMS
Fingerstick to obtain blood sample for analysis with YSI
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
| Milestone | Dario and Yellow Springs Instrument |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
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.
| percentage of participants | Dario Blood Glucose Monitoring System |
|---|---|
| < 75 mg/dl Within ±5mg/dL | 28.6 |
| < 75 mg/dl Within ±10mg/dL | 71.4 |
| < 75 mg/dl Within ±15mg/dL | 100 |
| >= 75 mg/dl Within ±5% | 32.5 |
| >= 75 mg/dl Within ±10% | 60.1 |
| >=75 mg/dl Within ±15% | 87.6 |
| >=75 mg/dl Within ±20% | 99.2 |
| < 100 mg/dl Within ±5mg/dL | 28.8 |
| < 100 mg/dl Within ±10mg/dL | 61.4 |
| < 100 mg/dl Within ±15mg/dL | 97.7 |
| >=100 mg/dl Within ±5% | 35.7 |
| >=100 mg/dl Within ±10% | 65.5 |
| >=100 mg/dl Within ±15% | 95.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dario Blood Glucose Monitoring System | — | 0/52 (0%) | 0/52 (0%) |
| YSI STAT | — | 0/52 (0%) | 0/52 (0%) |
| Age, Categorical(Participants) | Dario and Yellow Springs Instrument |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 2 |
| Age, Continuous(years) | Dario and Yellow Springs Instrument |
|---|---|
| Mean | 41.44 (20 to 66) |
| Sex: Female, Male(Participants) | Dario and Yellow Springs Instrument |
|---|---|
| Female | 26 |
| Male | 26 |
| Region of Enrollment(participants) | Dario and Yellow Springs Instrument |
|---|---|
| United States | 52 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
LabStyle Innovations Ltd.