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NCT03851549 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03851549
Other study ID # 3178226
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 12, 2019
Est. completion date April 19, 2019

Study information
Verified date March 2019
Source LifeScan Scotland Ltd
Contact Lorna Stewart
Phone +44 01463 721000
Email LSTEWAR5@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 360
Est. completion date April 19, 2019
Est. primary completion date April 19, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• New BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)

Locations
Country Name City State
Germany Institut für Diabetes-Technologie Ulm
United Kingdom Birmingham Heartlands Hospital Birmingham
United Kingdom Royal Infirmary of Edinburgh Edinburgh Lothian
United Kingdom Centre for Health Science Inverness

Sponsors (2)
Lead Sponsor Collaborator
LifeScan Scotland Ltd Institut für Diabetes-Technologie ( IfDT)

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary User Performance ( UP) 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
Primary System Use Evaluation 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
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