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
Diabetes Mellitus+2
+ Endocrine System Diseases
+ Metabolic Diseases
Summary
Study start date: September 1, 2016
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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, 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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, GermanyOpen Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm in Google Maps