Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany (IDT-1206-BA)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Status: Completed

Conditions: Diabetes

Treatments: Device: 4 blood glucose monitoring systems

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01789021

IDT-1206-BA

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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