Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

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

Status: Completed

Conditions: Diabetes

Treatments: Device: 7 Blood glucose monitoring systems

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01729546

IDT-1212

Details and patient eligibility

About

In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• People with diabetes Typ 1 or Typ 2 and people without diabetes
• for BG adjustment people with diabetes Typ 1 or Typ 2
• informed consent

Exclusion criteria

• pregnancy or lactation period
• severe acute diseases
• severe chronic diseases