Clinical trial NCT03085251: Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
Official title: Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: LifeScan
First posted: 2017-03-21
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.


Eligibility criteria: Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes (or subjects without diabetes)
* 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:

* Pregnancy or lactation period
* 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

Primary outcomes:
measure: System accuracy criteria
timeFrame: For each subject, the experimental phase has an expected duration of up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
state: Baden-Württemberg
Study officials:
References: