System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System

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

Status: Completed

Conditions: Diabetes

Treatments: Device: Blood glucose monitoring systems for point-of-care-testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02710617

IDT-1542-IU

Details and patient eligibility

About

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
• Signed informed consent form
• Minimum age of 18 years
• Subjects are legally competent and capable to understand character, meaning and consequences of the study.
• If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
• Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
• Signature of subjects to document consent with these procedures on informed consent form.

Exclusion criteria

• Pregnancy or lactation period
• Severe acute disease (at the study physician's discretion)
• Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
• Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
• Being unable to give informed consent
• < 18 years
• Legally incompetent
• Being committed to an institution (e.g. psychiatric clinic)
• Language barriers potentially compromising an adequate compliance with study procedures
• Dependent on investigator or sponsor
• If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2, see Fehler! Verweisquelle konnte nicht gefunden werden.), subjects with type 1 diabetes, suffering from:
• Coronary heart disease
• Condition after myocardial infarction
• Condition after cerebral events
• Peripheral arterial occlusive disease
• Hypoglycemia unawareness