Diabetes
Conditions
Brief summary
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.
Detailed description
Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.
Interventions
Finger-stick obtained with BGMS
DEVICEYSI
Finger-stick sample obtained by nurse/technician to be tested with YSI
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject has Type I or Type II diabetes 2. Subject speaks and reads English proficiently 3. Subjects owns and uses Android and iOS based smart mobile device for at least 1 year 4. Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study).
Exclusion criteria
1. Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS) 2. Subject is critically ill 3. Subject has an impairment that prevents him/her to follow the study procedures 4. Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician | 5 minutes | Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 368 |
| Total | 368 |
Baseline characteristics
| Characteristic | Dario Blood Glucose Monitoring System |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 65 Participants |
| Age, Categorical Between 18 and 65 years | 300 Participants |
| Age, Continuous | 52.4 years |
| Race/Ethnicity, Customized Americam Indian or Alaska Natice | 3 participants |
| Race/Ethnicity, Customized Asian | 7 participants |
| Race/Ethnicity, Customized Black or African America | 81 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Ilander | 1 participants |
| Race/Ethnicity, Customized Other | 8 participants |
| Race/Ethnicity, Customized White | 267 participants |
| Region of Enrollment United States | 368 participants |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 368 |
| serious Total, serious adverse events | 0 / 368 |
Outcome results
Primary
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
Time frame: 5 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |
| Dario Blood Glucose Monitoring System | 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 |