Diabetes MellitusNCT02718703
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
A study testing Blood Glucose Monitoring System. in people with Diabetes Mellitus, run by LifeScan at 1 site in United Kingdom.
Trial summary
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Blood Glucose Monitoring System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Female subjects who are pregnant or lactating.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
- User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
- Conditions
- Diabetes Mellitus
- Being tested
- 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.
Blood Glucose Monitoring System.Device
In vitro diagnostic medical device
| Study group | Role | What they receive |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) Receives: Device: Blood Glucose Monitoring System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.
UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)
Measured: Up to 1 hour
System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.
Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
Measured: Up to 1 hour
System Use Evaluation - HCP ( HealthCare Professional) questionnaire
Assessing use of BGMS and supporting material by subject.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorna Stewart, Study director, LifeScan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718703
- Sponsor's protocol ID
- 3129822
- Status last verified
- Sep 2016
- First submitted
- 1 Mar 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
- ClinicalTrials.gov ID
- NCT02718703
- Acronym / sponsor ID
- 3129822
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Device: Blood Glucose Monitoring System.Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Female subjects who are pregnant or lactating.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
- User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this 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 |
|---|---|---|
| Blood Glucose Monitoring System.In vitro diagnostic medical device | Device | Blood Glucose monitoring System (BGMS) |
Primary outcome
User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.
Time frame: Up to 1 hour
UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)
System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.
Time frame: Up to 1 hour
Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
System Use Evaluation - HCP ( HealthCare Professional) questionnaire
Time frame: Up to 1 hour
Assessing use of BGMS and supporting material by subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- 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.
Lorna Stewart study director
LifeScan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Glucose Monitoring System. in people with Diabetes Mellitus, run by LifeScan at 1 site in United Kingdom.
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 0 inclusion and 3 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 14 Sep 2016. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument. (time frame: Up to 1 hour). The study lists 3 primary outcomes in all. 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 14 Sep 2016.