Clinical trial NCT01556529: CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 405
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: HbA1c, incidence of typical diabetes complications
timeFrame: 36 months (max)
Secondary outcomes:
measure: quantitative diabetes typical complication risk profile
timeFrame: 36 months (max)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg Medical Center
Study officials:
affiliation: Medical School, Marburg University, Marburg, State of Hesse: Germany
name: Ulrich O Mueller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: