Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood glucose monitoring systems for self-testing (BGMS)

Device

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 names: OneTouch® Verio Flex

Primary outcomes

System accuracy criteria

Time frame: For each subject, the experimental phase has an expected duration of up to 6 hours

Based on EN ISO 15197:2015 (ISO 15197:2013) (E), the BGMS shall meet both of the following criteria:

Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).

Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.

Sponsors and collaborators

Lead sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Other

Collaborators

LifeScan

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 21, 2017
Registry last updated: Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed