Diabetes
Conditions
Keywords
blood glucose monitoring systems, ISO 15197, system accuracy
Brief summary
In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.
Interventions
DEVICE4 blood glucose monitoring systems
Sponsors
Bayer
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
* 18 years of age or older * Male or female subjects with type 1 or type 2 diabetes or healthy subjects * For BG adjustment people with type 1 diabetes
Exclusion criteria
* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient * Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient * Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study * For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness * Legal incompetence or limited legal competence * Age \< 18 years * Dependency from the sponsor or the clinical investigator * Mental incapacity or language barriers precluding adequate compliance with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value | For each subject, the experimental phase has an expected duration of up to 6 hours |
Countries
Germany
Outcome results
None listed