Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

July 4, 2011 updated by: Abbott Diabetes Care

Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices

A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany & Holland.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

501

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
      • Münster, Germany, 48145
        • Zentrum für Diabetes und Gefäßerkrankungen
      • Neuwied, Germany, 56564
        • Diabetes Zentrum Neuwied
  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Centre

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 480 subjects with type 1 or 2 diabetes mellitus

Description

Inclusion Criteria:

  • Subjects diagnosed with type 1 or type 2 diabetes mellitus
  • Age between 18 and 75 years.
  • Patients with stable blood glucose in judgment of the investigator.
  • Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
  • Patients perform blood glucose self measurements on a routine basis
  • Patients must have experience in self measurement blood glucose for at least 6 months.

Exclusion Criteria:

  • Patients with unstable blood glucose in judgment of the investigator.
  • Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
  • Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
  • Subject without legal capacity.
  • Blood donation within the last 30 days.
  • Known pregnancy.
  • Subject has already participated in the study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Diabetes
Patients with Type 1 or Type 2 diabetes requiring insulin.

Collaborators and Investigators

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

Sponsor

Abbott Diabetes Care

Collaborators

ikfe-CRO GmbH

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

December 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-MKG-FSL-10008

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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