Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03189225

Acronym

CAVALRY

Enrollment

120

Registered

2017-06-16

Start date

2016-08-01

Completion date

2016-09-01

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

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.

Interventions

OTHERCapillary And Venous Accuracy

Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).	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.	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)	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).	Within 24 hours	The following biochemistry parameters were analysed in mmol/l: Calcium, adjusted calcium, Chloride, Glucose, Potassium, Sodium, Triglycerides, urea, urate, Total Co2

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026