Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

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

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

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)
Patients with Type 1 or Type 2 diabetes requiring insulin.


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


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
Please refer to this study by its identifier: NCT01234727

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

No publications provided

Responsible Party: Harald Pohlmeier, Zentrum für Diabetes und Gefäßerkrankungen 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 processed this record on April 16, 2014