Trial Outcomes & Findings for Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude (NCT NCT02352298)
NCT ID: NCT02352298
Last Updated: 2017-06-09
Results Overview
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.
COMPLETED
NA
52 participants
6 seconds
2017-06-09
Participant Flow
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).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
52
|
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Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude
Baseline characteristics by cohort
| Measure |
Dario and Yellow Springs Instrument
n=52 Participants
Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
41.44 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 secondsAccuracy 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.
Outcome measures
| Measure |
Dario Blood Glucose Monitoring System
n=52 Participants
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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|---|---|
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Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
< 75 mg/dl Within ±5mg/dL
|
28.6 percentage of participants
|
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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 Accuracy at High Altitude (ISO 15197:2003)
< 75 mg/dl Within ±15mg/dL
|
100 percentage of participants
|
|
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 Accuracy at High Altitude (ISO 15197:2003)
>= 75 mg/dl Within ±10%
|
60.1 percentage of participants
|
|
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 Accuracy at High Altitude (ISO 15197:2003)
>=75 mg/dl Within ±20%
|
99.2 percentage of participants
|
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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 Accuracy at High Altitude (ISO 15197:2003)
< 100 mg/dl Within ±10mg/dL
|
61.4 percentage of participants
|
|
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 Accuracy at High Altitude (ISO 15197:2003)
>=100 mg/dl Within ±5%
|
35.7 percentage of participants
|
|
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 Accuracy at High Altitude (ISO 15197:2003)
>=100 mg/dl Within ±15%
|
95.2 percentage of participants
|
Adverse Events
Dario Blood Glucose Monitoring System
YSI STAT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Satish K. Garg
Barbara Davis Center for Childhood Diabetes
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60