Diabetes
Conditions
Brief summary
The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person. The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.
Detailed description
Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL).
Interventions
DEVICEDario™ Blood Glucose Meter
Each subject will undergo a finger prick and also provide a venous blood sample
DEVICEYSI2003
Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Healthy volunteers
No
Inclusion criteria
* Male or female between the age 18 and 80 * Type 1 and Type 2 diabetes
Exclusion criteria
* Drug and alcohol abuse * Investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BGMS Accuracy Assessment When Used by Layperson | Within 6 seconds of applying blood drop to strip | The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Ease of Use of the Dario BGMS by the Lay-person | Within a couple of hours from the time labelling material was provided to the subject | Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use. |
Participant flow
Pre-assignment details
230 patients were consented, the patients from day one (n=68) were excluded from the final results analysis due to a number of technical issues.
Participants by arm
| Arm | Count |
|---|---|
| Dario BGMS Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample
YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy. | 161 |
| Total | 161 |
Baseline characteristics
| Characteristic | Dario BGMS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 66 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 17.6 |
| Region of Enrollment Israel | 161 participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 161 |
| serious Total, serious adverse events | 0 / 161 |
Outcome results
Primary
BGMS Accuracy Assessment When Used by Layperson
The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)
Time frame: Within 6 seconds of applying blood drop to strip
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | >= 75 mg/dl Within ±5% | 44 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | >= 75 mg/dl Within ±10% | 78 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | >= 75 mg/dl Within ±15% | 126 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | < 75 mg/dl Within ±5mg/dL | 2 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | < 75 mg/dl Within ±10mg/dL | 4 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | < 75 mg/dl Within ±15mg/dL | 6 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | >= 75 mg/dl Within ±20% | 150 percentage of participants |
| Dario BGMS | BGMS Accuracy Assessment When Used by Layperson | >= 75 mg/dl | 155 percentage of participants |
Secondary
Evaluation of the Ease of Use of the Dario BGMS by the Lay-person
Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.
Time frame: Within a couple of hours from the time labelling material was provided to the subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dario BGMS | Evaluation of the Ease of Use of the Dario BGMS by the Lay-person | 93 participants |
| Dario BGMS (Understood After Few Attempts) | Evaluation of the Ease of Use of the Dario BGMS by the Lay-person | 67 participants |
| Dario BGMS (Did Not Understand How to Use) | Evaluation of the Ease of Use of the Dario BGMS by the Lay-person | 1 participants |