Diabetes MellitusNCT02910674

Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

A study testing Dario Blood Glucose Monitoring System in people with Diabetes Mellitus, 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 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. Read more about this study

Who is it for?: Ages 13 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus
What is being tested?: Dario Blood Glucose Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Jul 2016to Aug 2016
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 13 to 80 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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%.

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: Dario Blood Glucose Monitoring System - Android Devices User Performance

Read the 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.

Conditions: Diabetes Mellitus
Being tested: Dario Blood Glucose Monitoring System
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
Accuracy with usability assessment

Study groups in NCT02910674
Study group	Role	What they receive
One Arm	Other	This is a comparative diagnostic study, no interventional actions are being taken. Receives: Device: Dario Blood Glucose Monitoring System

What is being measured

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

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.
Measured: 1 Day
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?
Measured: 1 Day
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?
Measured: 1 Day
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.
Measured: 1 Day

Timeline

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

Jul 2016Aug 2016

First posted22 Sep 2016 (estimated)
Study startJul 2016
Primary completionJul 2016
Study completionAug 2016

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 Diabetes MellitusStudies 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910674
Sponsor's protocol ID: CP-0004
Status last verified: Mar 2021
First submitted: 20 Sep 2016
Last updated: 13 Apr 2021
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dario Blood Glucose Monitoring System - Android Devices User Performance
ClinicalTrials.gov ID: NCT02910674
Acronym / sponsor ID: CP-0004
Conditions: Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2016
Primary completion: Jul 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 22 Sep 2016 (estimated)
Results: Posted 13 Apr 2021

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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
One Arm	Other	Device: Dario Blood Glucose Monitoring SystemThis is a comparative diagnostic study, no interventional actions are being taken.

Who may qualify

Ages: 13 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (5 listed)

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%.

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 SystemAccuracy with usability assessment	Device	One Arm

Primary outcome

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.
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?
Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
Time frame: 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?"
Time frame: 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.

Results and safety

Results posted to the registry on 13 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetes (Type I or II), Ages 13-80	102	102

Primary outcome: Accuracy of Glucose Concentrations (%)

Time frame: 1 Day. Number (95% Confidence Interval). Unit: percentage of measurements within range

Measure	Diabetes (Type I or II), Ages 13-80 n = 102
Value	97.4 (95 to 100)

Primary outcome: Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"

Time frame: 1 Day. Mean (Full Range). Unit: score on a scale

Measure	One Arm n = 102
Value	4.4 (1 to 5)

Population analysed: 102 ranked their success in operating Dario™ BGMS 1-5. 1- Completely failed, 5- Very successful

Primary outcome: Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"

Time frame: 1 Day. Mean (Full Range). Unit: score on a scale

Measure	One Arm n = 102
Value	3.9 (1 to 5)

Population analysed: 102 ranked their ease in operating Dario™ BGMS 1-5. 1- Very Hard, 5- Very Easy

Primary outcome: Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	One Arm n = 102
Value	102

Adverse events

Time frame: 4 Days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetes (Type I or II), Ages 13-80	0 of 102 (0%)	0 of 102 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
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Recruiting
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Recruiting
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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 in people with Diabetes Mellitus, 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 3 inclusion and 5 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 13 Apr 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 13 Apr 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 of Glucose Concentrations (%) (time frame: 1 Day). The study lists 4 primary outcomes in all. 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 NCT02910674.

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 13 Apr 2021.