Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01789021
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Germany