Clinical trial NCT03189225: Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
Official title: Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).
timeFrame: Within 24 hours
measure: BG results of 3 BGMSs vs hospital's laboratory biochemistry analyser.
timeFrame: Within 24 hours
measure: BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)
timeFrame: Within 24 hours
measure: Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
timeFrame: Within 24 hours
measure: Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
timeFrame: Within 24 hours
measure: Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
timeFrame: Within 24 hours
measure: Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
timeFrame: Within 24 hours
measure: Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
timeFrame: Within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Diabetes Centre, Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Inverness
country: United Kingdom
facility: Highland Diabetes Institute
Study officials:
affiliation: LifeScan
name: Kirsty Macleod
role: STUDY_DIRECTOR
References: