Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
NCT ID: NCT03085251
Last Updated: 2017-09-26
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.
COMPLETED
NA
109 participants
INTERVENTIONAL
2017-03-16
2017-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 measurement
Blood glucose monitoring systems for self-testing (BGMS)
Measurement procedure
* Subjects will be asked to wash and dry their hands before the measurements.
* The measurement procedure for each reagent system lot of a BGMS will be as follows:
* Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.
* Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.
* Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.
* The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood glucose monitoring systems for self-testing (BGMS)
Measurement procedure
* Subjects will be asked to wash and dry their hands before the measurements.
* The measurement procedure for each reagent system lot of a BGMS will be as follows:
* Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.
* Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.
* Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.
* The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.
* If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
* Signature of subjects to document consent with these procedures on informed consent form.
Exclusion Criteria
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2), subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LifeScan
INDUSTRY
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDT-1653-LI
Identifier Type: -
Identifier Source: org_study_id