Institut Fuer Diabetes-Technologie Surveillance Program

February 25, 2019 updated by: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

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

  • Germany
      • Ulm, Germany, 89081
        • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm

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:

  • 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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For each subject, the experimental phase has an expected duration of up to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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.

General Publications

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 (Actual)

November 14, 2018

Primary Completion (Actual)

December 5, 2018

Study Completion (Actual)

December 5, 2018

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDT-1722-IU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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