IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

April 8, 2016 updated by: IMS HEALTH GmbH & Co. OHG

Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.

Study Type

Observational

Enrollment (Actual)

2104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany, 60325
        • Praxis Dr. med. Birgit Böttger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Type 2 Diabetes Mellitus

Description

Inclusion Criteria:

  • Provision of signed written informed consent
  • Age of 18 years or older
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 Diabetes Mellitus
Patients with antidiabetic treatment for Type 2 Diabetes Mellitus
Drug: antidiabetic treatment (ATC A10B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)
Time Frame: From date of registration every 3 months until end of study (up to 120 months)
The objective of the project is to develop a sustainable Type 2 Diabetes Mellitus (T2DM) registry to collect daily routine treatment data (e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) to provide a better understanding of the disease specific epidemiology, treatment patterns, patient relevant outcomes, patient subgroups, specifically among patients with Type 2 Diabetes Mellitus. Further DDG ("Deutsche Diabetes Gesellschaft") guideline adherence and economic aspects of diabetes treatment should be evaluated on the basis of this registry data.
From date of registration every 3 months until end of study (up to 120 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IMS HEALTH GmbH & Co. OHG

Investigators

  • Study Chair: Stephan Martin, Prof. Dr., Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5050000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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