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Completed

NCT Number: NCT03189225

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Centre, Heartlands Hospital, Birmingham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capillary And Venous Accuracy

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Acronym: CAVALRY

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2017
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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