Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE November 13, 2014
Last Update Posted Date December 23, 2014
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment [ Time Frame: up to 6 hours ]
  • User performance of blood glucose monitoring systems indicated by patient [questionnaire] [ Time Frame: up to 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
Official Title  ICMJE EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes
Intervention  ICMJE
  • Device: Blood glucose monitoring system (Omnitest 3)
  • Device: Blood glucose monitoring system (Omnitest 5)
  • Device: Blood glucose monitoring system (Omnitest 5D)
Study Arms  ICMJE
  • Active Comparator: Omnitest 3
    Blood glucose monitoring system
    Intervention: Device: Blood glucose monitoring system (Omnitest 3)
  • Experimental: Omnitest 5
    Blood glucose monitoring system
    Intervention: Device: Blood glucose monitoring system (Omnitest 5)
  • Experimental: Omnitest 5D
    Blood glucose monitoring system
    Intervention: Device: Blood glucose monitoring system (Omnitest 5D)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 12, 2014)
130
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290067
Other Study ID Numbers  ICMJE OPM-G-V-1203
IDT-1340-BE ( Other Identifier: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party B. Braun Melsungen AG
Study Sponsor  ICMJE B. Braun Melsungen AG
Collaborators  ICMJE Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Investigators  ICMJE
Principal Investigator: Nina Jendrike, Dr. med. Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
PRS Account B. Braun Melsungen AG
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP