- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02910674
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
Dario Blood Glucose Monitoring System - Android Devices User Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Barbara Davis Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: One Arm
This is a comparative diagnostic study, no interventional actions are being taken.
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Accuracy with usability assessment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of Glucose Concentrations (%)
Time Frame: 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. |
1 Day
|
Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"
Time Frame: 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? |
1 Day
|
Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
Time Frame: 1 Day
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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? |
1 Day
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Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"
Time Frame: 1 Day
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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. |
1 Day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP-0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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