Analytical Performance Evaluation of Blood Glucose Monitoring Systems

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm1 site in 1 country120 target enrollmentFebruary 2013

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Enrollment: 120
Locations: 1
Primary Endpoint: Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

April 2013

Last Updated

10 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value

Time Frame: For each subject, the experimental phase has an expected duration of up to 6 hours