Diabetes Mellitus Type 2 Clinical Trial
Official title:
CDRM Study: Computer-assisted Diabetes Risk Management-evaluation of a Medical Care Approach to Support Secondary and Tertiary Prevention of Type 2 Diabetes Mellitus and Its Complications
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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