CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The CDRM study will evaluate a newly developed approach to improve management and secondary
      prevention in diabetes care. The research will explore the impact of an medical care
      intervention via a computer-assisted diabetes risk management system (CDRMS) on compliance
      and outcome The focus will be on the effect on patients' diabetes and diabetes complication
      risk profiles, medical effectiveness and patients- reported outcomes.
    

Detailed description: 
      The study will determine the effects of a computer-assisted diabetes risk management (CDRM)
      system on compliance and outcome. All subjects are Type 2 Diabetes Mellitus (T2DM) patients
      enrolled in the National T2DM Disease Management Programme (DMP) offered by the German
      National Health Insurance System. Of all people living in Germany 90% are insured there; more
      than 60% of all T2DM patients insured there are - voluntarily - enrolled in the T2DM-DMP. As
      in any DMP, the rationale is that by regular visits to the attending physician, strict
      application of National Guidelines and by keeping the patient in a narrow corridor of optimal
      biomedical parameters (SBP, DBP, BMI, and specific lab parameters), the probability of
      complications, hospitalizations and other functional impairments is minimized.

      The rationale of the study is that more information on individual risk profile and its
      changes in the course of care will lead to more patient empowerment adding to more effective
      preventing the manifestation of these risks.

      The Intervention Group, in addition to receiving the T2DM care standard according to the
      National Guidelines issued by AWMF, within the framework of the National T2DM Disease
      Management Programme, will receive individualized reports showing their personal risk for the
      characteristic T2DM complications. Reports are sent to attending general practitioners (GP)
      for communicating and explaining them to patients.

      The CDRM system entails a combination of several telematic instruments used by the patient,
      GP and medical specialists. Key functionalities of the network supporting the care approach
      are the software integration of GP practices and an automated data recording via digital
      devices of blood glucose meters. Furthermore, the CDRM-Tool, Accu-Chek Mellibase a client
      server application of Roche Diagnostics GmbH is connected to the system.

      It generates reports - one for the physician and one for the patient - on the current health
      status, describing the 10 year risk to develop a characteristic complication (separately for
      myocardial infarction, stroke, kidney failure, blindness, amputation) and the potential to
      reduce this risk. These reports shall be used during consultations to help doctors and
      patients to communicate about diabetes associated risks and individual potential. The GP
      report shall ease doctor's therapy decisions. The patient report shall inform the patient to
      improve compliance, strengthen empowerment. The CDRM system gains this information by
      correlating the basic patient data plus the data from recent medical findings with the most
      recent diabetes research evidence. GPs of this intervention group will only get advice
      concerning how to use the CDRM system properly, no further (extra) intervention measures are
      permitted. In particular, no therapy recommendations from the research team to GPs how to
      decide on individual therapy or medication.

      The control group will receive the T2DM care standard according to the National Guidelines
      issued by AWMF, within the framework of the National T2DM Disease Management Programme.
    

Intervention name(s): risk profile information; standard DMP care; standard DMP care
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): (1) patient on a regular basis receives individualized reports on his/her quantitative risk for 6 typical diabetes complications over the next 10 years, (2) standard T2DMP care, as outlined by AWMF diabetes guidelines; standard disease management of T2DM care; standard disease management of T2DM care
Other intervention name(s): risk calculator; AWMF Guidelines oriented care; risk calculator
Intervention MeSH terms: Unithiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention