DiabetesNCT02053584

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

A study testing Dario™ Blood Glucose Meter and YSI2003 in people with Diabetes, run by LabStyle Innovations Ltd..

Completed

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

Trial summary

The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes
What is being tested?: Dario™ Blood Glucose Meter and YSI2003
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: No sites listed yet
Study dates: Jun 2013to Jun 2013
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female between the age 18 and 80
Type 1 and Type 2 diabetes

Who cannot join

Drug and alcohol abuse
Investigator discretion

About this study

The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.

Read the detailed description

Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: "The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL)".

Conditions: Diabetes
Being tested: Dario™ Blood Glucose Meter, YSI2003
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 MeterDevice
Each subject will undergo a finger prick and also provide a venous blood sample
YSI2003Device
Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.

Study groups in NCT02053584
Study group	Role	What they receive
Dario BGMS	Experimental	Not described Receives: Device: Dario™ Blood Glucose Meter; Device: YSI2003

What is being measured

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

BGMS Accuracy Assessment When Used by Layperson
The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)
Measured: Within 6 seconds of applying blood drop to strip

Secondary outcomes (1)

Evaluation of the Ease of Use of the Dario BGMS by the Lay-person
Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.
Measured: Within a couple of hours from the time labelling material was provided to the subject

Timeline

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

Jun 2013Jun 2013

First posted3 Feb 2014 (estimated)
Study startJun 2013
Primary completionJun 2013
Study completionJun 2013

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: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02053584
Sponsor's protocol ID: CR-0002
Status last verified: Jul 2016
First submitted: 30 Jan 2014
Last updated: 21 Dec 2021
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?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dario™ Blood Glucose Monitoring System - User Performance Evaluation
ClinicalTrials.gov ID: NCT02053584
Acronym / sponsor ID: CR-0002
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 21 Dec 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dario BGMS	Experimental	Device: Dario™ Blood Glucose Meter, Device: YSI2003

Who may qualify

Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or female between the age 18 and 80
Type 1 and Type 2 diabetes

Key exclusion criteria (2 listed)

Drug and alcohol abuse
Investigator discretion

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 MeterEach subject will undergo a finger prick and also provide a venous blood sample	Device	Dario BGMS
YSI2003Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.	Device	Dario BGMS

Primary outcome

BGMS Accuracy Assessment When Used by Layperson
Time frame: Within 6 seconds of applying blood drop to strip
The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)

1 secondary outcome

Evaluation of the Ease of Use of the Dario BGMS by the Lay-person
Time frame: Within a couple of hours from the time labelling material was provided to the subject

Results and safety

Results posted to the registry on 21 Dec 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
Dario BGMS	230	230

Primary outcome: BGMS Accuracy Assessment When Used by Layperson

Time frame: Within 6 seconds of applying blood drop to strip. Number. Unit: percentage of participants

Measure	Dario BGMS n = 161
< 75 mg/dl Within ±5mg/dL	2
< 75 mg/dl Within ±10mg/dL	4
< 75 mg/dl Within ±15mg/dL	6
>= 75 mg/dl Within ±5%	44
>= 75 mg/dl Within ±10%	78
>= 75 mg/dl Within ±15%	126
>= 75 mg/dl Within ±20%	150
>= 75 mg/dl	155

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dario BGMS	0 of 161 (0%)	0 of 161 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Julio Vainstein, MD principal investigator

Wolfson Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing Dario™ Blood Glucose Meter and YSI2003 in people with Diabetes, run by LabStyle Innovations Ltd..

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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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 21 Dec 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?

BGMS Accuracy Assessment When Used by Layperson (time frame: Within 6 seconds of applying blood drop to strip). 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 NCT02053584.

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 21 Dec 2021.