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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2016

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

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

Arms, Groups and Cohorts

  • Other: Capillary And Venous Accuracy
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeScan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kirsty Macleod, Study Director, LifeScan

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