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System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02290067
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Blood glucose monitoring system (Omnitest 3) Device: Blood glucose monitoring system (Omnitest 5) Device: Blood glucose monitoring system (Omnitest 5D) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Omnitest 3
Blood glucose monitoring system
Device: Blood glucose monitoring system (Omnitest 3)
Experimental: Omnitest 5
Blood glucose monitoring system
Device: Blood glucose monitoring system (Omnitest 5)
Experimental: Omnitest 5D
Blood glucose monitoring system
Device: Blood glucose monitoring system (Omnitest 5D)



Primary Outcome Measures :
  1. System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment [ Time Frame: up to 6 hours ]
  2. User performance of blood glucose monitoring systems indicated by patient [questionnaire] [ Time Frame: up to 4 hours ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02290067


Locations
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Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft
ULM, Germany, 89081
Sponsors and Collaborators
B. Braun Melsungen AG
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Investigators
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Principal Investigator: Nina Jendrike, Dr. med. Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02290067    
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 )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by B. Braun Melsungen AG:
blood glucose monitoring system
system accuracy
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases