Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234727
• Other study ID #: ADC-MKG-FSL-10008
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: July 4, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Germany	Zentrum für Diabetes und Gefäßerkrankungen	Münster
Germany	Diabetes Zentrum Neuwied	Neuwied
Netherlands	Radboud University Nijmegen Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Diabetes Care	ikfe-CRO GmbH

Countries where clinical trial is conducted

Germany,  Netherlands,