Dario™ Blood Glucose Monitoring System - User Performance Evaluation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)".
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dario BGMS
|
Device: Dario™ Blood Glucose Meter
Each subject will undergo a finger prick and also provide a venous blood sample
Device: YSI2003
Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- LabStyle Innovations Ltd.
Investigators
- Principal Investigator: Julio Vainstein, MD, Wolfson Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-0002
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Dario BGMS |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 230 |
| COMPLETED | 230 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Dario BGMS |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 161 |
| Age (years) [Median (Standard Deviation) ] | |
| Median (Standard Deviation) [years] |
55.5
(17.6)
|
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
95
59%
|
| >=65 years |
66
41%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
97
60.2%
|
| Male |
64
39.8%
|
| Region of Enrollment (participants) [Number] | |
| Israel |
161
100%
|
Outcome Measures
| Title | BGMS Accuracy Assessment When Used by Layperson |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dario BGMS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 161 |
| < 75 mg/dl Within ±5mg/dL |
2
1.2%
|
| < 75 mg/dl Within ±10mg/dL |
4
2.5%
|
| < 75 mg/dl Within ±15mg/dL |
6
3.7%
|
| >= 75 mg/dl Within ±5% |
44
27.3%
|
| >= 75 mg/dl Within ±10% |
78
48.4%
|
| >= 75 mg/dl Within ±15% |
126
78.3%
|
| >= 75 mg/dl Within ±20% |
150
93.2%
|
| >= 75 mg/dl |
155
96.3%
|
| Title | Evaluation of the Ease of Use of the Dario BGMS by the Lay-person |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dario BGMS (Easily Understood) | Dario BGMS (Understood After Few Attempts) | Dario BGMS (Did Not Understand How to Use) |
|---|---|---|---|
| Arm/Group Description | Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were easily understood. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy. | Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were understood after few attempts. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy. | Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were not clear and that they did not understand how to use. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy. |
| Measure Participants | 161 | 161 | 161 |
| Number [participants] |
93
57.8%
|
67
NaN
|
1
NaN
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Dario BGMS | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Dario BGMS | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Dario BGMS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/161 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Dario BGMS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/161 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Julio Weinstein |
|---|---|
| Organization | Wolfson Medical Center |
| Phone | 972-3-5028371 |
| vainstein@wolfson.health.gov.il |
- CR-0002