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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.
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)".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dario BGMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dario™ Blood Glucose Meter | Device | Each subject will undergo a finger prick and also provide a venous blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within 6 seconds of applying blood drop to strip |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within a couple of hours from the time labelling material was provided to the subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Vainstein, MD | Wolfson Medical Center | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | percentage of participants | Within 6 seconds of applying blood drop to strip |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio Weinstein | Wolfson Medical Center | 972-3-5028371 | vainstein@wolfson.health.gov.il |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| YSI2003 | Device | Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy. |
|
| years |
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| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Posted | Number | participants | Within a couple of hours from the time labelling material was provided to the subject |
|
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| 0 |
| 161 |
| 0 |
| 161 |
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