Diabetes Mellitus
Conditions
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.
Interventions
DEVICEBlood 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.
Sponsors
LifeScan
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System accuracy criteria | 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. |
Countries
Germany
Outcome results
None listed