NCT03515421

Brief Summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
2 countries

4 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

April 9, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2018

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

April 10, 2018

Last Update Submit

September 8, 2020

Conditions

Diabetes MellitusHealthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.

    UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)

    Up to 1 hour

  • System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.

    Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.

    Up to 1 hour

  • System Use Evaluation questionnaire

    Assessment of how the patient uses the BGMS.

    Up to 15 minutes

  • Instructions for Use Evaluation questionnaire.

    Questionnaires to assess the effectiveness of the instructions for use.

    Up to 10 days.

  • Marketing Claims Evaluation questionnaire.

    Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.

    Up to 10 days

Study Arms (1)

Blood Glucose monitoring System (BGMS)

EXPERIMENTAL

Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

Device: Frazier 3 VerioDevice: Frazier 3 UltraPlus

Interventions

Frazier 3 VerioDEVICE

In vitro diagnostic device (IVDD)

Blood Glucose monitoring System (BGMS)
Frazier 3 UltraPlusDEVICE

In vitro diagnostic device (IVDD)

Blood Glucose monitoring System (BGMS)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age - Subject is at least 12 years old.
  • Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
  • Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
  • Language - Subject reads and understands local language
  • SMBG status confirmed
  • Subject agrees to complete all aspects of the study

You may not qualify if:

  • Conflict of Interest
  • Pregnancy - Subject is pregnant (as confirmed by Subject)
  • User Performance Accuracy Testing - Technical Expertise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut für Diabetes-Technologie

Ulm, D-89081, Germany

Location

Diabetes Centre

Birmingham, B9 5SS, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Centre for Health Science

Inverness, IV2 3JH, United Kingdom

Location

Related Publications (1)

  • Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2.

    PMID: 31375031DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lorna Stewart

    LifeScan Scotland

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2018

First Posted

May 3, 2018

Study Start

April 9, 2018

Primary Completion

June 18, 2018

Study Completion

June 18, 2018

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

DE(1)GB(3)