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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Capillary And Venous Accuracy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capillary And Venous Accuracy<br>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. | Other: Capillary And Venous Accuracy<br>* Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | Within 24 hours |