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

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.

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 blood glucose monitoring systems

Device

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

Bayer

Registry information

Official study title

Analytical Performance Evaluation of Blood Glucose Monitoring Systems

Acronym: IDT-1206-BA

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Feb 11, 2013
Registry last updated: Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed