- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729546
Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus
January 13, 2015 updated by: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus [Following EN ISO 15197:2003 - 7.3 System Accuracy Evaluation] Part 40 of Study IDT-2010
In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed.
This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ulm, Germany, 89081
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- People with diabetes Typ 1 or Typ 2 and people without diabetes
- for BG adjustment people with diabetes Typ 1 or Typ 2
- informed consent
Exclusion Criteria:
- pregnancy or lactation period
- severe acute diseases
- severe chronic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluation of System Accuracy according to ISO 15197
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 14, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimate)
November 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDT-1212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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