Status:
COMPLETED
Assessment of Blood Glucose Monitoring Systems
Lead Sponsor:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01909687
Start Date
July 1 2013
End Date
December 1 2013
Last Update
June 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Ulm, Germany, 89081