Diabetes Mellitus Type 2CDRM_DMPNCT01556529
CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications
A study testing risk profile information and standard DMP care in people with Diabetes Mellitus Type 2, run by Philipps University Marburg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 40 to 68 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- risk profile information and standard DMP care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM,
- Enrollment in a T2DM RSAV DMP (German State Health Insurance DMP)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- risk profile information, standard DMP care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk profile informationProcedure or surgery
Also called risk calculator
(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 careProcedure or surgery
Also called AWMF Guidelines oriented care
standard disease management of T2DM care
standard DMP careProcedure or surgery
Also called risk calculator
standard disease management of T2DM care
| Study group | Role | What they receive |
|---|---|---|
| risk profile information | Experimental | patient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care Receives: Procedure: risk profile information; Procedure: standard DMP care |
| Control | Active comparator | Control group: patient gets standard T2DM DMP care Receives: Procedure: standard DMP care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, incidence of typical diabetes complications
Measured: 36 months (max)
Secondary outcomes (1)
quantitative diabetes typical complication risk profile
Measured: 36 months (max)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJun 2007
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Ulrich Mueller, Philipps University Marburg
- Investigators
- Ulrich O Mueller, MD PhD, Principal investigator, Medical School, Marburg University, Marburg, State of Hesse: Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556529
- Sponsor's protocol ID
- CDRM 92/07/56
- Acronym
- CDRM_DMP
- Status last verified
- Mar 2012
- First submitted
- 21 Feb 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01556529
- Acronym / sponsor ID
- CDRM_DMP / CDRM 92/07/56
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risk profile information | Experimental | Procedure: risk profile information, Procedure: standard DMP carepatient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care |
| Control | Active comparator | Procedure: standard DMP careControl group: patient gets standard T2DM DMP care |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of T2DM,
- Enrollment in a T2DM RSAV DMP (German State Health Insurance DMP)
Key exclusion criteria (16 listed)
- Pregnant
- Dementia, psychoses, or other illness that would hinder compliance
- Serious illness such as:
- Malabsorption syndromes such as colitis and Morbus Crohns disease.
- Bed-ridden or required supportive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risk profile informationAlso: risk calculator(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 | Procedure or surgery | risk profile information |
| standard DMP careAlso: AWMF Guidelines oriented carestandard disease management of T2DM care | Procedure or surgery | Control |
| standard DMP careAlso: risk calculatorstandard disease management of T2DM care | Procedure or surgery | risk profile information |
Primary outcome
HbA1c, incidence of typical diabetes complications
Time frame: 36 months (max)
1 secondary outcome
quantitative diabetes typical complication risk profile
Time frame: 36 months (max)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Deutsches Register Klinischer Studien (German Clinical Trials Register)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich O Mueller, MD PhD principal investigator
Medical School, Marburg University, Marburg, State of Hesse: Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risk profile information and standard DMP care in people with Diabetes Mellitus Type 2, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c, incidence of typical diabetes complications (time frame: 36 months (max)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.