Type 2 DiabetesMEDIAS-2-CTNCT02748239
Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes
A study testing MEDIAS 2 CT and Current CT program 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 non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) 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 CT and Current CT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to May 2016
- 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
- two years diabetes duration with oral treatment
- BMI > 20 and < 40 kg/m²
- written 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 Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
A new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) 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 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.
Read the detailed description
The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused 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-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons, which were conducted as group sessions.
- Conditions
- Type 2 Diabetes
- Being tested
- MEDIAS 2 CT, Current CT program
- Keywords
- diabetes self-management education, 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 CTBehavioural
The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
Current CT programBehavioural
The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
| Study group | Role | What they receive |
|---|---|---|
| MEDIAS 2 CT | Active comparator | The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. Receives: Behavioral: MEDIAS 2 CT |
| Current CT program | Placebo comparator | This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. Receives: Behavioral: Current CT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c values
Measured: six months follow up after termination of the programs
Secondary outcomes (6)
Quality of life
QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire.
Measured: six months follow up
Diabetes knowledge
A diabetes knowledge test for insulin treatment in type 2 diabetes will be used
Measured: six months follow up
Diabetes related emotional burden
Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire
Measured: six months follow up
Diabetes related distress
Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS)
Measured: six months follow up
Self-care behavior
The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used.
Measured: six months follow up
Depression
The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used.
Measured: six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 182 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
- NCT02748239
- Sponsor's protocol ID
- FIDAM-02-10
- Acronym
- MEDIAS-2-CT
- Status last verified
- Aug 2016
- First submitted
- 13 Apr 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. 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 Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02748239
- Acronym / sponsor ID
- MEDIAS-2-CT / FIDAM-02-10
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes self-management education, insulin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Apr 2016 (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 non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) 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 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.
Detailed description
The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused 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-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 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 CT | Active comparator | Behavioral: MEDIAS 2 CTThe MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. |
| Current CT program | Placebo comparator | Behavioral: Current CT programThis program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes
- two years diabetes duration with oral treatment
- BMI > 20 and < 40 kg/m²
- written 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 CTThe MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants). | Behavioural | MEDIAS 2 CT |
| Current CT programThe Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants). | Behavioural | Current CT program |
Primary outcome
A1c values
Time frame: six months follow up after termination of the programs
6 secondary outcomes
Quality of life
Time frame: six months follow up
Diabetes knowledge
Time frame: six months follow up
Diabetes related emotional burden
Time frame: six months follow up
Diabetes related distress
Time frame: six months follow up
Self-care behavior
Time frame: six months follow up
Depression
Time frame: six months 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 9 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 CT and Current CT program 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 4 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 9 Aug 2016. 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. Some participants in this study may receive a placebo. 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 months 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?
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 9 Aug 2016.