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

LifeScan120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

120

Conditions

Diabetes Mellitus

Interventions

Capillary And Venous AccuracyOTHER

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (3)

Diabetes Centre, Heartlands Hospital

Birmingham, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Highland Diabetes Institute

Inverness, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.