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Institut Fuer Diabetes-Technologie Surveillance Program

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: NCT03737188
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Brief Summary:
Assessment of the system accuracy of different blood glucose monitoring systems available in Europe

Condition or disease Intervention/treatment Phase
Diabetes Device: Blood glucose monitoring systems for self-testing Not Applicable

Detailed Description:
A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe
Actual Study Start Date : November 14, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar


Intervention Details:
  • Device: Blood glucose monitoring systems for self-testing
    Capillary blood samples will be used for the evaluation of system accuracy.
    Other Names:
    • 18 BGMS from 18 different manufacturers: ABRA, Accu-Chek Guide, AURUM Blutzucker-Messsystem, CareSens Dual, CERA-CHEK 1 Code, Contour next ONE, eBsensor, FreeStyle Freedom Lite, GL 50 (evo)
    • GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou Blutzuckermesssystem, WaveSense JAZZ WIRELESS


Primary Outcome Measures :
  1. Analysis of system accuracy based on ISO 15197 [ Time Frame: For each subject, the experimental phase has an expected duration of up to 6 hours ]
    Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197



Information from the National Library of Medicine

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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:

  • Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
  • Signed informed consent form
  • Minimum age of 18 years
  • ubjects are legally competent and capable to understand character, meaning and consequences of the study.
  • If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
  • Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
  • Signature of subjects to document consent with these procedures on informed consent form.

Exclusion Criteria:

  • Pregnancy or lactation period
  • Severe acute disease (at the study physician's discretion)
  • Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
  • Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
  • Being unable to give informed consent
  • < 18 years
  • Legally incompetent
  • Being committed to an institution (e.g. psychiatric clinic)
  • Language barriers potentially compromising an adequate compliance with study procedures
  • Dependent on investigator or sponsor
  • If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
  • Coronary heart disease
  • Condition after myocardial infarction
  • Condition after cerebral events
  • Peripheral arterial occlusive disease
  • Hypoglycemia unawareness

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): NCT03737188


Locations
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Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
ClinicalTrials.gov Identifier: NCT03737188    
Other Study ID Numbers: IDT-1722-IU
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases