Diabetes
Conditions
Brief summary
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).
Interventions
DEVICEBlood-Glucose Monitoring Systems for self-testing
This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS). The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel. Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter. Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method. Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter. The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented. An additional skin puncture will be performed by study personnel with single-use lancing devices.
Sponsors
Ascensia Diabetes Care
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System accuracy criteria (see description) | For each subject, the experimental phase has an expected duration of up to 3 hours | Acceptance criteria defined by ISO 15197:2013 (E) / EN ISO 15197:2015 will be applied: 95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations \< 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). |
Countries
Germany
Outcome results
None listed