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

Diabetes Mellitus Type 2 Clinical Trial

— CDRM_DMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556529
• Other study ID #: CDRM 92/07/56
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: March 20, 2012
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 68 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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
• standard DMP care
standard disease management of T2DM care
• standard DMP care
standard disease management of T2DM care

Locations

Country	Name	City	State
Germany	Philipps University Marburg Medical Center	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c, incidence of typical diabetes complications		36 months (max)	No
Secondary	quantitative diabetes typical complication risk profile		36 months (max)	Yes

External Links

•   Deutsches Register Klinischer Studien (German Clinical Trials Register)