Assessment of Blood Glucose Monitoring Systems
Overview
System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013
Full Title of Study: “Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich”
Study Type
- Study Type: Interventional
- Study Primary Completion Date: December 2013
Interventions
- Device: Blood glucose monitoring systems
Clinical Trial Outcome Measures
Primary Measures
- Analysis of system accuracy
- Time Frame: for each subject, the experimental phase has an expected duration of up to 6 hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Collaborator
- Sanofi
- Provider of Information About this Clinical Study
- Sponsor
Citations Reporting on Results
Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods. Diabetes Technol Ther. 2015 Sep;17(9):635-48. doi: 10.1089/dia.2015.0085. Epub 2015 Jun 25.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.