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Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany (IDT-1206-BA)

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ClinicalTrials.gov Identifier: NCT01789021
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : June 18, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Device: 4 blood glucose monitoring systems

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Official Title: Analytical Performance Evaluation of Blood Glucose Monitoring Systems
Study Start Date : February 2013
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789021


Locations
Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Bayer