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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
ClinicalTrials.gov Identifier:
NCT01789021
First received: February 8, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention
Diabetes
Device: 4 blood glucose monitoring systems

Study Type: Interventional
Official Title: Analytical Performance Evaluation of Blood Glucose Monitoring Systems

Resource links provided by NLM:


Further study details as provided by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
ClinicalTrials.gov Identifier: NCT01789021     History of Changes
Other Study ID Numbers: IDT-1206-BA
Study First Received: February 8, 2013
Last Updated: May 7, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm:
blood glucose monitoring systems
ISO 15197
system accuracy

ClinicalTrials.gov processed this record on August 28, 2014