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

Diabetes Mellitus Clinical Trial

— CAVALRY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189225
• Other study ID #: 3149479
• Status: Completed
• Phase: N/A
• First received: September 20, 2016
• Last updated: June 14, 2017
• Start date: August 1, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: June 2017
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Diabetes Centre, Heartlands Hospital	Birmingham
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Highland Diabetes Institute	Inverness

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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