Diabetes Mellitus
Conditions
Brief summary
This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).
Detailed description
This study will be a non-randomized study conducted to assess the accuracy and performance of the Dario Blood Glucose Monitoring System at an elevated altitude. 50 subjects will be enrolled in this study. Participation includes a 15-20 minute visit to the clinical site where they will be consented. The participant will then receive a fingerstick to obtain capillary blood used to test the performance of the BGMS and to obtain a comparative glucose measurement on the reference method, the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer.
Interventions
DEVICEBlood Glucose Monitoring System Altitude Performance
Performance as assessed against a reference method at an altitude of approximately 10,000 feet.
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to speak and read English
Exclusion criteria
* Pregnant * Has any condition that the principle investigator believes may interfere in the subject's participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful Glucose Readings | One day | The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes.
1. Age of subject is 18 years or older
2. Able to speak and read English | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes | — |
|---|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 18.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Number of Successful Glucose Readings
The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).
Time frame: One day
Population: Each subject will be measured 9 times with the Dario system: 3 strips lots for each of the three representative smart mobile devices (total of nine meters) under evaluation (150 strips per mobile device, total no. of strips 450).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes | Number of Successful Glucose Readings | 449 Number of Glucose readings in range |