System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

NCT ID: NCT02358408

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-04-30

Brief Summary

The study consists of 2 parts:

The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 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.

This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.

Conditions

Diabetes

Interventions

Blood glucose monitoring systems for self-testing

Intervention Type: DEVICE

Other Intervention Names

Karajishi Contour, Karajishi Contour TS

Eligibility Criteria

Inclusion Criteria

• Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
• For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
• Minimum age of 18 years
• Signed informed consent form
• Legally competent and capable to understand character, meaning and consequences of the study

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)
• Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
• Incapability of giving informed consent
• < 18 years
• Legally incompetent
• Accommodated in an institution (e.g. psychiatric clinic)
• Language barriers potentially compromising an adequate compliance with study procedures
• Dependent from investigator or sponsor
• For provoked blood glucose excursions 50 - 80 mg/dl:
• Coronary heart disease
• Condition after myocardial infarction
• Cerebral incidence
• Peripheral arterial occlusive disease
• Hypoglycemia unawareness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ulm, , Germany

Countries

Germany

References

Pleus S, Baumstark A, Rittmeyer D, Jendrike N, Haug C, Freckmann G. Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013. Curr Med Res Opin. 2016 May;32(5):847-55. doi: 10.1185/03007995.2016.1146666. Epub 2016 Feb 23.

Reference Type: BACKGROUND

PMID: 26809001 (View on PubMed)

Other Identifiers

IDT-1416-BL

Identifier Type: -

Identifier Source: org_study_id