Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.
Detailed description
The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.
Interventions
Accuracy with usability assessment
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has Type 1 or Type II diabetes * Subject speaks and reads English proficiently * 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
* Subject has medical training or works in the field of blood glucose monitoring systems. * Subject is critically ill. * Subject has an impairment that prevents him/her from following the study procedures. * Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study. * Hematocrit levels outside the range of 20%-60%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Glucose Concentrations (%) | 1 Day | Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations \< 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL. The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus. |
| Average Rank of the Indication of How Would Rate Your Success in Operating Dario BGMS | 1 Day | Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful. Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS? |
| Average Rank of the Indication of How Easy Was it to Operate the Dario™ BGMS on the First Time? | 1 Day | Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy. An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time? |
| Percent of Participants Responding 'YES' on the Question Did You Successfully Obtain Measurement Result Using the Dario™ BGMS? | 1 Day | The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS? 100% of subjects (102 of 102) answered Yes to this question. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetes (Type I or II), Ages 13-80 Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Diabetes (Type I or II), Ages 13-80 |
|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 34 Participants |
| Subjects with Type I and Type II diabetes | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Accuracy of Glucose Concentrations (%)
Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations \< 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL. The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus.
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes (Type I or II), Ages 13-80 | Accuracy of Glucose Concentrations (%) | 97.4 percentage of measurements within range |
Primary
Average Rank of the Indication of How Easy Was it to Operate the Dario™ BGMS on the First Time?
Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy. An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time?
Time frame: 1 Day
Population: 102 ranked their ease in operating Dario™ BGMS 1-5. 1- Very Hard, 5- Very Easy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes (Type I or II), Ages 13-80 | Average Rank of the Indication of How Easy Was it to Operate the Dario™ BGMS on the First Time? | 3.9 score on a scale |
Primary
Average Rank of the Indication of How Would Rate Your Success in Operating Dario BGMS
Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful. Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS?
Time frame: 1 Day
Population: 102 ranked their success in operating Dario™ BGMS 1-5. 1- Completely failed, 5- Very successful
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes (Type I or II), Ages 13-80 | Average Rank of the Indication of How Would Rate Your Success in Operating Dario BGMS | 4.4 score on a scale |
Primary
Percent of Participants Responding 'YES' on the Question Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?
The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS? 100% of subjects (102 of 102) answered Yes to this question.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetes (Type I or II), Ages 13-80 | Percent of Participants Responding 'YES' on the Question Did You Successfully Obtain Measurement Result Using the Dario™ BGMS? | 102 Participants |