Assessment of Blood Glucose Monitoring Systems
Not Applicable
Completed
- Conditions
- Diabetes
- Registration Number
- NCT01909687
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Brief Summary
System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of system accuracy for each subject, the experimental phase has an expected duration of up to 6 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
🇩🇪Ulm, Germany