DiabetesNCT02352298

Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

A study testing Dario Blood Glucose Monitoring System and YSI Analyzer in people with Diabetes, run by LabStyle Innovations Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes
What is being tested?: Dario Blood Glucose Monitoring System and YSI Analyzer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Feb 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age of subject is 18 years or older
Able to speak and read English

Who cannot join

Pregnant
Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Barbara Davis Center
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Protocol for the Evaluation of Dario™ Blood Glucose Monitor (BGMS) Performance at Elevated Altitude

Read the detailed description

The study will be performed with 50 fresh capillary blood samples, collected by fingerstick using Dario single use lancet. Additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the YSI 2300 STAT Plus analyzer. Additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.

Conditions: Diabetes
Being tested: Dario Blood Glucose Monitoring System, YSI Analyzer
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
Fingerstick to obtain blood sample for analysis with the Dario BGMS
YSI AnalyzerDevice
Fingerstick to obtain blood sample for analysis with YSI

Study groups in NCT02352298
Study group	Role	What they receive
Dario Blood Glucose Monitoring System	Experimental	Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System Receives: Device: Dario Blood Glucose Monitoring System
YSI STAT	Active comparator	Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System Receives: Device: YSI Analyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.
Measured: 6 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Feb 2015

First posted2 Feb 2015 (estimated)
Study startFeb 2015
Primary completionFeb 2015
Study completionFeb 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02352298
Sponsor's protocol ID: CP-0003
Status last verified: May 2017
First submitted: 21 Jan 2015
Last updated: 9 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for the Evaluation of Dario™ Blood Glucose Monitor (BGMS) Performance at Elevated Altitude
ClinicalTrials.gov ID: NCT02352298
Acronym / sponsor ID: CP-0003
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 2 Feb 2015 (estimated)
Results: Posted 9 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dario Blood Glucose Monitoring System	Experimental	Device: Dario Blood Glucose Monitoring SystemBlood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
YSI STAT	Active comparator	Device: YSI AnalyzerBlood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age of subject is 18 years or older
Able to speak and read English

Key exclusion criteria (2 listed)

Pregnant
Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.

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 SystemFingerstick to obtain blood sample for analysis with the Dario BGMS	Device	Dario Blood Glucose Monitoring System
YSI AnalyzerFingerstick to obtain blood sample for analysis with YSI	Device	YSI STAT

Primary outcome

Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
Time frame: 6 seconds
Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.

Results and safety

Results posted to the registry on 9 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dario and Yellow Springs Instrument	52	52

Primary outcome: Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)

Time frame: 6 seconds. Number. Unit: percentage of participants

Measure	Dario Blood Glucose Monitoring System n = 52
< 75 mg/dl Within ±5mg/dL	28.6
< 75 mg/dl Within ±10mg/dL	71.4
< 75 mg/dl Within ±15mg/dL	100
>= 75 mg/dl Within ±5%	32.5
>= 75 mg/dl Within ±10%	60.1
>=75 mg/dl Within ±15%	87.6
>=75 mg/dl Within ±20%	99.2
< 100 mg/dl Within ±5mg/dL	28.8

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dario Blood Glucose Monitoring System	0 of 52 (0%)	0 of 52 (0%)	Not reported
YSI STAT	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Christie Beatson study chair

Barbara Davis Center

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 Analyzer 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 2 inclusion and 2 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 9 Jun 2017. 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 9 Jun 2017). 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?

Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) (time frame: 6 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352298.

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 9 Jun 2017.