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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.
This study will gather data to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capillary And Venous Accuracy | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capillary And Venous Accuracy | Other | Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300) |
|
| 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). |
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Summary of Inclusion Criteria:
Summary of Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsty Macleod | LifeScan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Centre, Heartlands Hospital | Birmingham | B9 5SS | United Kingdom | |||
| NHS Lothian |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 |
| Edinburgh |
| EH16 4SA |
| United Kingdom |
| Highland Diabetes Institute | Inverness | IV2 3JH | United Kingdom |