CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications
NCT ID: NCT01556529
Last Updated: 2012-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
405 participants
INTERVENTIONAL
2007-06-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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risk profile information
patient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care
risk profile information
(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 DMP care
standard disease management of T2DM care
Control
Control group: patient gets standard T2DM DMP care
standard DMP care
standard disease management of T2DM care
Interventions
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risk profile information
(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 DMP care
standard disease management of T2DM care
standard DMP care
standard disease management of T2DM care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrollment in a T2DM RSAV DMP (German State Health Insurance DMP)
Exclusion Criteria
* Dementia, psychoses, or other illness that would hinder compliance
* Serious illness such as:
* cancer,
* immune deficiency syndrome (HIV),
* genetic lipid disorder (e.g. autosomal dominant familial hypercholesteremia).
* Malabsorption syndromes such as colitis and Morbus Crohns disease.
* Bed-ridden or required supportive care
* Cardiac insufficiency \> NYHA class II
* Chronic metabolic storage illnesses such as Morbus Wilson or Amyloidosis.
* Endocrinologic diseases with elevated anti-insulin hormone (e.g. hyperthyreosis, pheochromocytoma, acromegaly.
* Chronic inflammatory diseases.
* Chronic therapy with corticosteroids, diazoxide.
* Pancreatic Diabetes mellitus (e.g. alcoholism, chronic pancreatitis, pancreatic resection)
* Any illness that would prevent the active involvement of the patient in the present study
* Prevalence of diabetes typical complications
40 Years
68 Years
ALL
No
Sponsors
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Philipps University Marburg
OTHER
Responsible Party
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Prof. Ulrich Mueller
PROFESSOR
Principal Investigators
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Ulrich O Mueller, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Medical School, Marburg University, Marburg, State of Hesse: Germany
Locations
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Philipps University Marburg Medical Center
Marburg, , Germany
Countries
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Related Links
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Deutsches Register Klinischer Studien (German Clinical Trials Register)
Other Identifiers
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CDRM 92/07/56
Identifier Type: -
Identifier Source: org_study_id
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