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

NCT01556529 | Completed DMC

• 1 other identifier: CDRM 92/07/56
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c, incidence of typical diabetes complications

  36 months (max)

Secondary Outcomes (1)

• quantitative diabetes typical complication risk profile

  36 months (max)

Study Arms (2)

risk profile information

EXPERIMENTAL

patient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care

Procedure: risk profile information; Procedure: standard DMP care

Control

ACTIVE COMPARATOR

Control group: patient gets standard T2DM DMP care

Procedure: standard DMP care

Interventions

risk profile information PROCEDURE

(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

Also known as: risk calculator

risk profile information

standard DMP care PROCEDURE

standard disease management of T2DM care

Also known as: AWMF Guidelines oriented care

Control

Eligibility Criteria

• Age: 40 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University Marburg Medical Center

Marburg, 35043, Germany

Location

Related Links

• Deutsches Register Klinischer Studien (German Clinical Trials Register)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ulrich O Mueller, MD PhD

  Medical School, Marburg University, Marburg, State of Hesse: Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 16, 2012
• Study Start: June 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

DE (1)