IMS® DIAREG Diabetes Registry
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 Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||10 Years|
|Official Title:||Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus|
- 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) ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||September 2023|
|Estimated Primary Completion Date:||September 2023 (Final data collection date for primary outcome measure)|
Type 2 Diabetes Mellitus
Patients with antidiabetic treatment for Type 2 Diabetes Mellitus
|Drug: antidiabetic treatment (ATC A10B)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906294
|Contact: Kerstin Bode-Greuel, Dr. med.||+49 69 6604 ext 4637||KBode-Greuel@de.imshealth.com|
|Praxis Dr. med. Birgit Böttger||Recruiting|
|Frankfurt am Main, Germany, 60325|
|Contact: Birgit Böttger, Dr. med. 069 74 86 ext 86 firstname.lastname@example.org|
|Principal Investigator: Birgit Böttger, Dr. med.|
|Study Chair:||Stephan Martin, Prof. Dr.||Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)|