Diabetes MellitusOTVFSANCT03138174
OneTouch Verio Flex System Accuracy Evaluation
An observational study of Diabetes Mellitus, run by LifeScan at 3 sites in United Kingdom.
Trial summary
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- OneTouch Verio Flex Blood Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 23 Mar 2017to 2 May 2017
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will consist of subjects diagnosed with diabetes
Summary of Inclusion Criteria:
- All Subjects must be registered into the LFSS Patient Registry to participate in the study.
- Each Participant must read and sign the approved Informed Consent Form.
- Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.
Summary of Exclusion Criteria:
> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Diabetes Centre, Birmingham Heartlands Hospital
Birmingham, B9 5SS
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Highland Diabetes Institute
Inverness, IV2 3JH
About this study
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197
Read the detailed description
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.
- Conditions
- Diabetes Mellitus
- Being tested
- OneTouch Verio Flex Blood Glucose Monitoring System
- Keywords
- Blood Glucose Monitor System Accuracy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch Verio Flex Blood Glucose Monitoring SystemDevice
Blood Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | One group consisting of diabetic subjects Receives: Device: OneTouch Verio Flex Blood Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To meet the requirements of ISO 15197:2015
In order to meet the requirements of ISO 15197:2015
- For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals < 5.55 mmol/L (< 100 mg/dL) or within + 15 % at glucose concentrations > 5.55 mmol/L (> 100 mg/dL).
- 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start23 Mar 2017
- Primary completion2 May 2017
- Study completion2 May 2017
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Patrick, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138174
- Sponsor's protocol ID
- WI3052203
- Acronym
- OTVFSA
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De identified data may be shared by way of study reports and publications
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OneTouch Verio Flex System Accuracy Evaluation
- ClinicalTrials.gov ID
- NCT03138174
- Acronym / sponsor ID
- OTVFSA / WI3052203
- Conditions
- Diabetes Mellitus
- Keywords
- Blood Glucose Monitor System Accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 3 May 2017 (actual)
- 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 System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197
Detailed description
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Device: OneTouch Verio Flex Blood Glucose Monitoring SystemOne group consisting of diabetic subjects |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will consist of subjects diagnosed with diabetes
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 |
|---|---|---|
| OneTouch Verio Flex Blood Glucose Monitoring SystemBlood Glucose Monitoring System | Device | Diabetes |
Primary outcome
To meet the requirements of ISO 15197:2015
Time frame: Four weeks
In order to meet the requirements of ISO 15197:2015 1. For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals < 5.55 mmol/L (< 100 mg/dL) or within + 15 % at glucose concentrations > 5.55 mmol/L (> 100 mg/dL). 2. 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.
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 28 Jun 2017.
- Individual participant dataSharing planned: No. De identified data may be shared by way of study reports and publications
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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.
Alan Patrick principal investigator
National Health Service, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by LifeScan at 3 sites 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?
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 28 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 3 sites 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?
To meet the requirements of ISO 15197:2015 (time frame: Four weeks). 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 28 Jun 2017; AzTrials last refreshed its copy on 31 Oct 2026.