Trial Outcomes & Findings for User Performance Evaluation for DARIO™ BGMS (NCT NCT02357043)
NCT ID: NCT02357043
Last Updated: 2021-06-15
Results Overview
Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
368 participants
Primary outcome timeframe
5 minutes
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
Dario Blood Glucose Monitoring System
Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).
Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS
YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI
|
|---|---|
|
Overall Study
STARTED
|
368
|
|
Overall Study
COMPLETED
|
368
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
User Performance Evaluation for DARIO™ BGMS
Baseline characteristics by cohort
| Measure |
Dario Blood Glucose Monitoring System
n=368 Participants
Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).
Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS
YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
300 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=99 Participants
|
|
Age, Continuous
|
52.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Americam Indian or Alaska Natice
|
3 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African America
|
81 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Ilander
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
267 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
368 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 minutesBlood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
Outcome measures
| Measure |
Dario Blood Glucose Monitoring System
n=368 Participants
Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).
Dario Blood Glucose Monitoring System: Finger-stick obtained with BGMS
YSI: Finger-stick sample obtained by nurse/technician to be tested with YSI
|
|---|---|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>=75 mg/dl Within ±15%
|
328 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>= 100 mg/dl Within ±5%
|
111 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 75 mg/dl Within ±15mg/dL
|
24 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>=75 mg/dl Within ±5%
|
134 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>=75 mg/dl Within ±10%
|
257 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>=75 mg/dl Within ±20%
|
339 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 100 mg/dl Within ±5mg/dL
|
42 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 100 mg/dl Within ±10mg/dL
|
73 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 100 mg/dl Within ±15mg/dL
|
91 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>= 100 mg/dl Within ±10%
|
211 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
>= 100 mg/dl Within ±15%
|
265 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 75 mg/dl Within ±5mg/dL
|
12 Participants
|
|
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
< 75 mg/dl Within ±10mg/dL
|
22 Participants
|
Adverse Events
Dario Blood Glucose Monitoring System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60