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

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: antidiabetic treatment (ATC A10B)

• Registration Number: NCT01906294
• Lead Sponsor: IMS HEALTH GmbH & Co. OHG

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Study Start: 2013-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2104

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus	antidiabetic treatment (ATC A10B)	Patients with antidiabetic treatment for Type 2 Diabetes Mellitus

Primary Outcome Measures

Name	Time	Method
routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)	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.

Trial Locations

Locations (1)

Praxis Dr. med. Birgit Böttger; 🇩🇪 Frankfurt am Main, Germany