Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT01234727
- Lead Sponsor
- Abbott Diabetes Care
- Brief Summary
A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany \& Holland.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Zentrum für Diabetes und Gefäßerkrankungen
🇩🇪Münster, Germany
Diabetes Zentrum Neuwied
🇩🇪Neuwied, Germany
Radboud University Nijmegen Centre
🇳🇱Nijmegen, Netherlands