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 Ulm114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Enrollment

114

Conditions

Diabetes

Interventions

7 Blood glucose monitoring systemsDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Ulm, Germany

Outcomes

Primary Outcomes

Evaluation of System Accuracy according to ISO 15197

Data from ClinicalTrials.gov

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