1. CDRM Project Diabetes Management Stefan Stadler – November 2009

2. CDRM Diabetes Management20.09.20152  Corporate development and testing in clinical practice  Scientific evaluation of economic and medical effects of an e-health assisted Diabetes Risk Management and Monitoring Approach for large scale population settings. The computer-assisted diabetes risk management system (CDRM) combines several different clinical and information technology (IT) tools to improve diabetes care, patient adherence, and thus outcomes in population based disease management programs (DMP). Care provider and the patient take a centre stage within this approach which supports services of health care professionals, eases patients’ dealing with their own disease, and enhances the value of diagnostic information by improving the integration of different health care services. The CDRM Study will scientifically evaluate the economic and medical effect of this approach. www.study-on-diabetes-management-systems.de CDRM – Goals of the CDRM Project

3. CDRM Diabetes Management20.09.20153 CDRM – Clinical trial setting Prospective, longitudinal CRT design Target population for diabetes management: Type II diabetes patients (Age: 40-70) DMP-RSAV Participants approx. 1200 patients for 2 yrs 24 primary care practices Project objective Clinical proof of effectiveness: “Intensified diabetes risk management in Germany” The study design is registered at the German Clinical Trials Register: ID: DRKS00000056

4. CDRM Diabetes Management20.09.20154 CDRM – Clinical trial Questions Among others questions we address:  Are there sgnificant effects?  Outcomes + Costs  Are there significant demographic differences?  Target groups  What kind of tools are most significant?  e.g. Risk assessment  Is there a change in quality of life and patient health related behaviour?  e.g. Amount of blood glucose measurments !!!

5. CDRM Diabetes Management20.09.20155 CDRM - Cooperation Industry Partners Scientific Partners Phillips-Universität Marburg University of Groningen, NL ICW AGGeTeG mbH Co KGRoche Diagnostics GmbH

6. CDRM Diabetes Management20.09.20156 CDRM - Organizational structure Project Organisation Scientific Evaluation Ethical Requirements Funding / Support Telematic Technology Diabetes Care Project Organisation Marburg UniversityGeTeGRoche DiagnosticsControl Physicians Intervention Physicians InterComponentWareUniversity Medical Center Groningen Ethics Committee Diabetes Specialist GP network (Qu@linet) CDRM Project PatientsKKS Marburg

7. CDRM Diabetes Management20.09.20157 on population (DMP) level Care Organization Care Providers + Patients Business Requirements Disease Management Core Requirements o Screening o Communication o Recruitment o Monitoring

8. CDRM Diabetes Management20.09.20158 on case management level Care Organization Care Providers + Patients Business Requirements Care provision Case Management Core Requirements oCollection of data oAnalysis and interpretation of data oDecision making oIntervention, therapy oMonitoring of care progress

9. CDRM Diabetes Management20.09.20159 System Infrastructure Technology Provider Care Provider (GP, Coach etc.) Patient Study Coordination Computer Centre Print Service Postal services Care Organisation Service Analyzed Information VPN Access Data Monitoring Data upload Diabetes Care Workflow Processing BG Data Client Notebook (Browser) VPN Access CDRM Tool Client PC PHR + Devices CDM Diabetes Monitor (Life and Backup Server) Medical Parameters

10. CDRM Diabetes Management20.09.201510 Labor Integration Praxis Integration* KH Integration* Digitale Messgeräte Risk Report Therapy Goals Therapy Plan Compliance-/ Success Report Doctor-Patient Communication Patient Empowerment via CDRM Patient Document parameter progress (BG) Analyze trends Control parameters Specify goals continuous1x / 6 months1x / GP visit1x / 6 months Care Provider DiabetesManagementSystem

11. CDRM Diabetes Management20.09.201511 Expected Results of the CDRM Intervention Process Empowerment Awareness on Risks Planning and Control Transparency on Health Status

12. CDRM Diabetes Management20.09.201512 EbM Knowledge Risk prognosis included in today's decision making Risk Years Today Potential

13. CDRM Diabetes Management20.09.201513 ~190 2321 Contacts Contracts Rollouts Trainings GPs Medical Partners Marburg Groningen Going Live Data Measurement 4. in progress Milestones, Status November 2009 Patients ~650~260 Participants Potential Contracts 1. Roche ICW AG GeTeG Core Actors Software Integration 2. ICW AG Roche GeTeG (ICW LG) UNI Marburg Rollout Recruitment 3.

14. CDRM Diabetes Management20.09.201514 stadler@study-on-diabetes-management-systems.de