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

Sponsor
LifeScan (Industry)
Overall Status
Completed
CT.gov ID
NCT03189225
Collaborator
(none)
120
Enrollment
3
Locations
1
Arm
1
Actual Duration (Months)
40
Patients Per Site
39.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Capillary And Venous Accuracy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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 mmol/l: Calcium, adjusted calcium, Chloride, Glucose, Potassium, Sodium, Triglycerides, urea, urate, Total Co2

  5. 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 Umol/l: creatine, Bilirubin, total bilirubin, direct bilirubin

  6. 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 U/L: ALT, ALK. Phos, LDH- Architect

  7. 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 G/L: Albumin, Total protein

  8. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diabetes Centre, Heartlands Hospital Birmingham United Kingdom B9 5SS
2 NHS Lothian Edinburgh United Kingdom EH16 4SA
3 Highland Diabetes Institute Inverness United Kingdom IV2 3JH

Sponsors and Collaborators

  • LifeScan

Investigators

  • Study Director: Kirsty Macleod, LifeScan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LifeScan
ClinicalTrials.gov Identifier:
NCT03189225
Other Study ID Numbers:
  • 3149479
First Posted:
Jun 16, 2017
Last Update Posted:
Jun 16, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 16, 2017