A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
1 other identifier
interventional
360
2 countries
4
Brief Summary
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Mar 2019
Shorter than P25 for not_applicable diabetes-mellitus
4 active sites
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
First Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedStudy Start
First participant enrolled
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2019
CompletedMarch 8, 2019
March 1, 2019
1 month
February 21, 2019
March 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Blood Glucose monitoring System (BGMS)
EXPERIMENTALIntervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)
Interventions
New blood glucose monitoring system / In vitro diagnostic device (IVDD)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Conflict of interest. Technical expertise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeScan Scotland Ltdlead
- Institut für Diabetes-Technologie ( IfDT)collaborator
Study Sites (4)
Institut für Diabetes-Technologie
Ulm, D-89081, Germany
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Centre for Health Science
Inverness, IV2 3JH, United Kingdom
Related Publications (1)
Katz LB, Stewart L, King D, Cameron H. Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users. J Diabetes Sci Technol. 2020 Sep;14(5):912-916. doi: 10.1177/1932296820906184. Epub 2020 Feb 14.
PMID: 32059615DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kirsty Macleod
LifeScan Scotland
Central Study Contacts
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
February 21, 2019
First Posted
February 22, 2019
Study Start
March 12, 2019
Primary Completion
April 19, 2019
Study Completion
April 19, 2019
Last Updated
March 8, 2019
Record last verified: 2019-03