A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

March 6, 2019 updated by: LifeScan Scotland Ltd

US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.

This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.

Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Srikanth Bellary
      • Inverness, United Kingdom, IV2 3JH
        • Centre for Health Science
        • Contact:
        • Principal Investigator:
          • Dr. David Macfarlane
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
        • Contact:
        • Principal Investigator:
          • Dr. Nicola Zammitt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.

Summary of exclusion criteria:

Conflict of interest. Technical expertise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)
Device: New BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Performance ( UP)
Time Frame: < 30 minutes
User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.
< 30 minutes
System Use Evaluation
Time Frame: < 30 minutes
System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.
< 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan Scotland Ltd

Collaborators

Institut für Diabetes-Technologie ( IfDT)

Investigators

  • Study Director: Kirsty Macleod, LifeScan Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 12, 2019

Primary Completion (Anticipated)

April 19, 2019

Study Completion (Anticipated)

April 19, 2019

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 3178226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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