Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

This study has been completed.
Sponsor:
Collaborator:
ikfe-CRO GmbH
Information provided by:
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01234727
First received: November 3, 2010
Last updated: July 4, 2011
Last verified: March 2011
  Purpose

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


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Enrollment: 501
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes
Patients with Type 1 or Type 2 diabetes requiring insulin.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Up to 480 subjects with type 1 or 2 diabetes mellitus

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234727

Locations
Germany
Zentrum für Diabetes und Gefäßerkrankungen
Münster, Germany, 48145
Diabetes Zentrum Neuwied
Neuwied, Germany, 56564
Netherlands
Radboud University Nijmegen Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Abbott Diabetes Care
ikfe-CRO GmbH
Investigators
Study Director: Joe Bugler Abbott Diabetes Care
  More Information

No publications provided

Responsible Party: Harald Pohlmeier, Zentrum für Diabetes und Gefäßerkrankungen
ClinicalTrials.gov Identifier: NCT01234727     History of Changes
Other Study ID Numbers: ADC-MKG-FSL-10008
Study First Received: November 3, 2010
Last Updated: July 4, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Abbott Diabetes Care:
diabetes, SMBG, glucose testing systems, accuracy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 25, 2014