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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Capillary And Venous Accuracy

• Registration Number: NCT03189225
• Lead Sponsor: LifeScan

Brief 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.

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.

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Study First Submitted: 2016-09-20
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capillary And Venous Accuracy	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.

Primary Outcome Measures

Name	Time	Method
BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)	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.
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).	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.	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.
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).	Within 24 hours	The following biochemistry parameters were analysed in (/1.73m2): eGFR

Trial Locations

Locations (3)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Highland Diabetes Institute; 🇬🇧 Inverness, United Kingdom

Diabetes Centre, Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom