A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
NCT ID: NCT03851549
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
360 participants
INTERVENTIONAL
2019-03-12
2019-04-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
User Performance and System Accuracy Evaluations Using Glucose Adjustment
NCT02374879
Evaluation of an Investigational Blood Glucose Monitoring System
NCT01859494
Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
NCT03085251
System Accuracy of 12 Bloog Glucose Monitoring Systems
NCT05219526
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
NCT04033042
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
New BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
New BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut für Diabetes-Technologie ( IfDT)
UNKNOWN
LifeScan Scotland Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kirsty Macleod
Role: STUDY_DIRECTOR
LifeScan Scotland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut für Diabetes-Technologie
Ulm, , Germany
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Centre for Health Science
Inverness, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3178226
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.