Type 2 DiabetesMEDIAS-2-ICTNCT00901992
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
A study testing MEDIAS 2 ICT and Current ICT program (ACC-ICT) in people with Type 2 Diabetes, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.
Trial summary
A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed. In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- MEDIAS 2 ICT and Current ICT program (ACC-ICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Aug 2010
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- age < 75 and age > 17 years
- two years diabetes duration with oral treatment
- BMI > 20 nad BMI < 40 kg/m²
- informed consent
Who cannot join
- current psychiatric disease
- dementia or other severe cognitive impairment
- severe complications
- severe conditions (e.g., cancer)
- gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients
A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed.
In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.
The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will be separately analyzed and published.
Read the detailed description
The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.
The active comparator condition (ACC) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.
Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as group sessions.
- Conditions
- Type 2 Diabetes
- Being tested
- MEDIAS 2 ICT, Current ICT program (ACC-ICT)
- Keywords
- type 2 diabetes, education, self-management, insulin therapy
- 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.
MEDIAS 2 ICTBehavioural
MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants)
Current ICT program (ACC-ICT)Behavioural
This program is conducted in 10 lessons in a group setting (4-8 participants)
| Study group | Role | What they receive |
|---|---|---|
| MEDIAS 2 ICT | Experimental | MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients Receives: Behavioral: MEDIAS 2 ICT |
| Current ICT program (ACC) | Active comparator | This education program consists of 10 lessons combining an insulin education program with an hypertension program Receives: Behavioral: Current ICT program (ACC-ICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c values
Measured: six month follow up after termination of the programs
Secondary outcomes (6)
Quality of life using the SF 12 mental and physical composite scales
Measured: six month follow up
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
Measured: 6 month follow up
diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)
Measured: 6 month follow up
Self care behavior (Summary of Self-Care Activities Scale)
Measured: 6 month follow up
lipids (total cholesterol, triglycerides, HDL and LDL)
Measured: 6 month follow up
weight (Body mass index)
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Norbert Hermanns, PhD, Principal investigator, Forschungsinstitut der Diabetes Akademie Mergentheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901992
- Sponsor's protocol ID
- FIDAM-02-09
- Acronym
- MEDIAS-2-ICT
- Status last verified
- Aug 2014
- First submitted
- 12 May 2009
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermanns N, Kulzer B, Maier B, Mahr M, Haak T. The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes. Patient Educ Couns. 2012 Feb;86(2):226-32. doi: 10.1016/j.pec.2011.05.017. Epub 2011 Jun 28.
PubMed 21715124
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00901992
- Acronym / sponsor ID
- MEDIAS-2-ICT / FIDAM-02-09
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, education, self-management, insulin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 May 2009 (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.
A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed.
In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.
The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will be separately analyzed and published.
Detailed description
The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.
The active comparator condition (ACC) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.
Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as group sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDIAS 2 ICT | Experimental | Behavioral: MEDIAS 2 ICTMEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients |
| Current ICT program (ACC) | Active comparator | Behavioral: Current ICT program (ACC-ICT)This education program consists of 10 lessons combining an insulin education program with an hypertension program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- type 2 diabetes
- age < 75 and age > 17 years
- two years diabetes duration with oral treatment
- BMI > 20 nad BMI < 40 kg/m²
- informed consent
Key exclusion criteria (5 listed)
- current psychiatric disease
- dementia or other severe cognitive impairment
- severe complications
- severe conditions (e.g., cancer)
- gestational diabetes
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 |
|---|---|---|
| MEDIAS 2 ICTMEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants) | Behavioural | MEDIAS 2 ICT |
| Current ICT program (ACC-ICT)This program is conducted in 10 lessons in a group setting (4-8 participants) | Behavioural | Current ICT program (ACC) |
Primary outcome
A1c values
Time frame: six month follow up after termination of the programs
6 secondary outcomes
Quality of life using the SF 12 mental and physical composite scales
Time frame: six month follow up
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
Time frame: 6 month follow up
diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)
Time frame: 6 month follow up
Self care behavior (Summary of Self-Care Activities Scale)
Time frame: 6 month follow up
lipids (total cholesterol, triglycerides, HDL and LDL)
Time frame: 6 month follow up
weight (Body mass index)
Time frame: 6 month follow up
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 11 Aug 2014.
- Results publication: PubMed 21715124Hermanns N, Kulzer B, Maier B, Mahr M, Haak T. The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes. Patient Educ Couns. 2012 Feb;86(2):226-32. doi: 10.1016/j.pec.2011.05.017. Epub 2011 Jun 28.
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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.
Norbert Hermanns, PhD principal investigator
Forschungsinstitut der Diabetes Akademie Mergentheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDIAS 2 ICT and Current ICT program (ACC-ICT) in people with Type 2 Diabetes, run by Forschungsinstitut der Diabetes Akademie Mergentheim 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 5 inclusion and 5 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 11 Aug 2014. 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?
A1c values (time frame: six month follow up after termination of the programs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901992, which also lists 1 linked publication.
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 11 Aug 2014.