DiabetesNCT02357043
User Performance Evaluation for DARIO™ BGMS
A study testing Dario Blood Glucose Monitoring System and YSI in people with Diabetes, run by LabStyle Innovations Ltd. at 1 site in United States.
Trial summary
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- Dario Blood Glucose Monitoring System and YSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has Type I or Type II diabetes
- Subject speaks and reads English proficiently
- Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
- 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).
Who cannot join
- Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
- Subject is critically ill
- Subject has an impairment that prevents him/her to follow the study procedures
- Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.
Read the detailed description
Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.
- Conditions
- Diabetes
- Being tested
- Dario Blood Glucose Monitoring System, YSI
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dario Blood Glucose Monitoring SystemDevice
Finger-stick obtained with BGMS
YSIDevice
Finger-stick sample obtained by nurse/technician to be tested with YSI
| Study group | Role | What they receive |
|---|---|---|
| Dario Blood Glucose Monitoring System | Experimental | Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS). Receives: Device: Dario Blood Glucose Monitoring System; Device: YSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- LabStyle Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357043
- Sponsor's protocol ID
- CP-0002
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2015
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)
- ClinicalTrials.gov ID
- NCT02357043
- Acronym / sponsor ID
- CP-0002
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.
Detailed description
Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dario Blood Glucose Monitoring System | Experimental | Device: Dario Blood Glucose Monitoring System, Device: YSISubject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has Type I or Type II diabetes
- Subject speaks and reads English proficiently
- Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
- 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).
Key exclusion criteria (4 listed)
- Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
- Subject is critically ill
- Subject has an impairment that prevents him/her to follow the study procedures
- Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dario Blood Glucose Monitoring SystemFinger-stick obtained with BGMS | Device | Dario Blood Glucose Monitoring System |
| YSIFinger-stick sample obtained by nurse/technician to be tested with YSI | Device | Dario Blood Glucose Monitoring System |
Primary outcome
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
Time frame: 5 minutes
Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dario Blood Glucose Monitoring System and YSI in people with Diabetes, run by LabStyle Innovations Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.