NCT03189225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

September 20, 2016

Last Update Submit

June 14, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (8)

  • 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).

    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

Study Arms (1)

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.

Other: Capillary And Venous Accuracy

Interventions

Capillary And Venous AccuracyOTHER

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

Capillary And Venous Accuracy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Diabetes Centre, Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

Highland Diabetes Institute

Inverness, IV2 3JH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kirsty Macleod

    LifeScan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2016

First Posted

June 16, 2017

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)