Status:
COMPLETED
Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
Lead Sponsor:
Abbott Diabetes Care
Collaborating Sponsors:
ikfe-CRO GmbH
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Brief Summary
A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany \& Holland.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT01234727
Start Date
December 1 2010
End Date
March 1 2011
Last Update
July 6 2011
Active Locations (3)
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1
Zentrum für Diabetes und Gefäßerkrankungen
Münster, Germany, 48145
2
Diabetes Zentrum Neuwied
Neuwied, Germany, 56564
3
Radboud University Nijmegen Centre
Nijmegen, Netherlands, 6500 HB