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

November 3, 2010
July 4, 2011
December 2010
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01234727 on ClinicalTrials.gov Archive Site
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Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Up to 480 subjects with type 1 or 2 diabetes mellitus

Diabetes Mellitus
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Diabetes
Patients with Type 1 or Type 2 diabetes requiring insulin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT01234727
ADC-MKG-FSL-10008
No
Harald Pohlmeier, Zentrum für Diabetes und Gefäßerkrankungen
Abbott Diabetes Care
ikfe-CRO GmbH
Study Director: Joe Bugler Abbott Diabetes Care
Abbott Diabetes Care
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP