CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications (CDRM_DMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Ulrich Mueller, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01556529
First received: February 21, 2012
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
Procedure: risk profile information
Procedure: standard DMP care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • HbA1c, incidence of typical diabetes complications [ Time Frame: 36 months (max) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quantitative diabetes typical complication risk profile [ Time Frame: 36 months (max) ] [ Designated as safety issue: Yes ]

Enrollment: 405
Study Start Date: June 2007
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: risk profile information
patient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care
Procedure: 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
Other Name: risk calculator
Procedure: standard DMP care
standard disease management of T2DM care
Other Name: risk calculator
Active Comparator: Control
Control group: patient gets standard T2DM DMP care
Procedure: standard DMP care
standard disease management of T2DM care
Other Name: AWMF Guidelines oriented care

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.

  Eligibility

Ages Eligible for Study:   40 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T2DM,
  • Enrollment in a T2DM RSAV DMP (German State Health Insurance DMP)

Exclusion Criteria:

  • Pregnant
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556529

Locations
Germany
Philipps University Marburg Medical Center
Marburg, Germany, 35043
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Ulrich O Mueller, MD PhD Medical School, Marburg University, Marburg, State of Hesse: Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Ulrich Mueller, PROFESSOR, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01556529     History of Changes
Other Study ID Numbers: CDRM 92/07/56
Study First Received: February 21, 2012
Last Updated: March 20, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014