User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197:2013; EN ISO 15197:2015
Blood-Glucose Monitoring Systems for self-testing
Diabète Mellitus+2
+ Maladies du système endocrinien
+ Maladies métaboliques
Résumé
Date de début de l'étude : 1 septembre 2016
Date à laquelle le premier participant a commencé l'étude.The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus One (Ascensia Diabetes Care GmbH), Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO 15197:2015, clause 8. For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects. The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.140 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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, subjects with type 1 diabetes, suffering from: * Coronary heart disease * Condition after myocardial infarction * Condition after cerebral events * Peripheral arterial occlusive disease * Hypoglycemia unawareness Inclusion and exclusion criteria defined by ISO 15197:2013; EN ISO 15197:2015: * Only subjects with diabetes type 1 or type 2 will be included. * Demographic data will be collected to demonstrate that subjects represent different ages, genders and education levels. * In deviation from ISO 15197:2013; EN ISO 15197:2015, included subjects may have participated in a study involving the BGMS, but must not yet have performed measurements with the BGMS according to their own statement for the last 3 years. * In addtition, included subjects did not use the BGMS being evaluated at home for the last 3 years according to their own statement. * In order to ensure that capillary blood samples meet the requirements indicated in the manufacturer's labelling, * a physician will review the subjects' anamnesis and medication and check for interfering substances indicated in the manufacturer's labelling. * the hematocrit value of each subject will be checked to be within the range indicated in the manufacturer's labelling (hematocrit determination before or after the measurement procedure).
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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