Diabetes MellitusCAVALRYNCT03189225
Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
A study testing Capillary And Venous Accuracy in people with Diabetes Mellitus, run by LifeScan at 3 sites in United Kingdom.
Trial summary
This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Capillary And Venous Accuracy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Aug 2016to 1 Sep 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Summary of Inclusion Criteria:
- Male or Female subjects with T1DM or T2DM.
- Must be able to read and sign the approved consent form.
- Registered into the LifeScan patient registry.
- Currently performing self monitoring of blood glucose ( SMBG)
Summary of Exclusion Criteria:
- Conflict of Interest - Prospective Participants will be excluded from enrollment if they are currently working for, have previously worked for, or have an immediate family member working for a company that manufactures or markets the type of products tested under the scope of this procedure.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Diabetes Centre, Heartlands Hospital
Birmingham, B9 5SS
NHS Lothian
Edinburgh, EH16 4SA
Highland Diabetes Institute
Inverness, IV2 3JH
About this study
This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser.
Read the detailed description
This study will gather data to:
- Determine if extreme bias can be observed between 3 candidate products for user accuracy.
- Assess the offset between venous blood samples versus capillary blood samples.
- Determine if there are measurable donor factors which influence the product bias.
- Assess any offset between YSI 2300 reference instruments and hospital laboratory analyser and impact on bias difference between BGM product types.
- Conditions
- Diabetes Mellitus
- Being tested
- Capillary And Venous 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.
Capillary And Venous AccuracyOther
Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)
| Study group | Role | What they receive |
|---|---|---|
| Capillary And Venous Accuracy | Other | All subjects provided blood sample(s) to be tested on three Blood Glucose Monitoring Systems ( OneTouch Ultra 2, OneTouch Verio (Rice), OneTouch SelectPlus), LifeScan reference instrument ( YSI 2300) and hospitals own biochemistry analysers. Receives: Other: Capillary And Venous Accuracy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).
Comparison of Blood glucose results between 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) using capillary and Venous blood samples.
Measured: Within 24 hours
BG results of 3 BGMSs vs hospital's laboratory biochemistry analyser.
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to hospitals own laboratory biochemistry analyser using venous blood.
Measured: Within 24 hours
BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to LifeScan's reference instrument ( YSI 2300) using venous and capillary blood.
Measured: Within 24 hours
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
The following biochemistry parameters were analysed in mmol/l: Calcium, adjusted calcium, Chloride, Glucose, Potassium, Sodium, Triglycerides, urea, urate, Total Co2
Measured: Within 24 hours
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
The following biochemistry parameters were analysed in Umol/l: creatine, Bilirubin, total bilirubin, direct bilirubin
Measured: Within 24 hours
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
The following biochemistry parameters were analysed in U/L: ALT, ALK. Phos, LDH- Architect
Measured: Within 24 hours
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
The following biochemistry parameters were analysed in G/L: Albumin, Total protein
Measured: Within 24 hours
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
The following biochemistry parameters were analysed in (/1.73m2): eGFR
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Aug 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsty Macleod, Study director, LifeScan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189225
- Sponsor's protocol ID
- 3149479
- Acronym
- CAVALRY
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
- ClinicalTrials.gov ID
- NCT03189225
- Acronym / sponsor ID
- CAVALRY / 3149479
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 16 Jun 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.
This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser.
Detailed description
This study will gather data to:
- Determine if extreme bias can be observed between 3 candidate products for user accuracy.
- Assess the offset between venous blood samples versus capillary blood samples.
- Determine if there are measurable donor factors which influence the product bias.
- Assess any offset between YSI 2300 reference instruments and hospital laboratory analyser and impact on bias difference between BGM product types.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary And Venous Accuracy | Other | Other: Capillary And Venous AccuracyAll subjects provided blood sample(s) to be tested on three Blood Glucose Monitoring Systems ( OneTouch Ultra 2, OneTouch Verio (Rice), OneTouch SelectPlus), LifeScan reference instrument ( YSI 2300) and hospitals own biochemistry analysers. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Capillary And Venous AccuracyCapillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300) | Other | Capillary And Venous Accuracy |
Primary outcome
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).
Time frame: Within 24 hours
Comparison of Blood glucose results between 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) using capillary and Venous blood samples.
BG results of 3 BGMSs vs hospital's laboratory biochemistry analyser.
Time frame: Within 24 hours
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to hospitals own laboratory biochemistry analyser using venous blood.
BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)
Time frame: Within 24 hours
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to LifeScan's reference instrument ( YSI 2300) using venous and capillary blood.
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
Time frame: Within 24 hours
The following biochemistry parameters were analysed in mmol/l: Calcium, adjusted calcium, Chloride, Glucose, Potassium, Sodium, Triglycerides, urea, urate, Total Co2
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
Time frame: Within 24 hours
The following biochemistry parameters were analysed in Umol/l: creatine, Bilirubin, total bilirubin, direct bilirubin
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
Time frame: Within 24 hours
The following biochemistry parameters were analysed in U/L: ALT, ALK. Phos, LDH- Architect
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
Time frame: Within 24 hours
The following biochemistry parameters were analysed in G/L: Albumin, Total protein
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
Time frame: Within 24 hours
The following biochemistry parameters were analysed in (/1.73m2): eGFR
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 16 Jun 2017.
- 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.
Kirsty Macleod study director
LifeScan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capillary And Venous Accuracy in people with 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 16 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?
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS). (time frame: Within 24 hours). The study lists 8 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 16 Jun 2017.