Assessment of Blood Glucose Monitoring Systems

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

Status: Completed

Conditions: Diabetes

Treatments: Device: Blood glucose monitoring systems

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01909687

IDT-1313-SF

Details and patient eligibility

About

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Enrollment: 163 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