Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

NCT ID: NCT01234727

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

Patients with Type 1 or Type 2 diabetes requiring insulin.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ikfe-CRO GmbH

INDUSTRY

Sponsor Role collaborator

Abbott Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Zentrum für Diabetes und Gefäßerkrankungen

Principal Investigators

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Joe Bugler

Role: STUDY_DIRECTOR

Abbott Diabetes Care

Locations

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Zentrum für Diabetes und Gefäßerkrankungen

Münster, , Germany

Site Status

Diabetes Zentrum Neuwied

Neuwied, , Germany

Site Status

Radboud University Nijmegen Centre

Nijmegen, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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ADC-MKG-FSL-10008

Identifier Type: -

Identifier Source: org_study_id

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