- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290067
System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
December 19, 2014 updated by: B. Braun Melsungen AG
EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems.
For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
130
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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-
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ULM, Germany, 89081
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft
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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:
- Subjects with type 1 or type 2 diabetes and healthy subjects
- Signed and dated informed consent form
- For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
Exclusion Criteria:
- Pregnancy or lactation period
- Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
- Mental incapacity or language barriers precluding adequate compliance with the test procedures
- Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
- Legal incompetence or limited legal competence
- Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
- For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
- For system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
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?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omnitest 5
Blood glucose monitoring system
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Active Comparator: Omnitest 3
Blood glucose monitoring system
|
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Experimental: Omnitest 5D
Blood glucose monitoring system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
Time Frame: up to 6 hours
|
up to 6 hours
|
User performance of blood glucose monitoring systems indicated by patient [questionnaire]
Time Frame: up to 4 hours
|
up to 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nina Jendrike, Dr. med., Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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
October 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
October 22, 2014
First Submitted That Met QC Criteria
November 12, 2014
First Posted (Estimate)
November 13, 2014
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 19, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPM-G-V-1203
- IDT-1340-BE (Other Identifier: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm)
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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