Type 1 DiabetesNCT01691287
MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes
A study testing Michael Method in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Michael Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Dec 2013
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 Diabetes at least 1 year prior to study inclusion
- 12-17 years old
- HbA1c > 7.8%
Who cannot join
- Incapability to comply with all study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well.
Compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age.
Read more
The Michael Method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. The method was developed in 1988 by a multi-disciplinary team of professional academic in Israel. Today the Israeli education system implements the method in Junior High Schools and High Schools in diverse educational sectors. The program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the Ministries of Defense and Social Welfare, the National Insurance Institute, the National Electric Corporation and in many other public and private frameworks.
The proposed study is aimed to assess whether the Michael Method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes
- Conditions
- Type 1 Diabetes
- Being tested
- Michael Method
- Keywords
- Type 1 Diabetes, Metabolic Control, Quality of Life
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Michael MethodBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Michael Method | Experimental | 14 group meeting, taking place once a week during 14 consecutive weeks Receives: Behavioral: Michael Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control measured as HbA1c level
Measured: at the end of the study - after 15 weeks
Secondary outcomes (4)
Diabetes Quality of Life questionnaire (DQOLY)
Measured: At the end of the study- after 15 weeks
Self assessment questionnaire
Measured: At the end of the study- after 15 weeks
Number of severe hypoglycemic events
Measured: at the end of the study-after 15 weeks
Number of Diabetic Keto Acidosis events
Measured: at the end of the study- after 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691287
- Sponsor's protocol ID
- rmc006444ctil
- Status last verified
- Apr 2014
- First submitted
- 19 Sep 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01691287
- Acronym / sponsor ID
- rmc006444ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Metabolic Control, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Sep 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.
Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well.
Compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age.
The Michael Method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. The method was developed in 1988 by a multi-disciplinary team of professional academic in Israel. Today the Israeli education system implements the method in Junior High Schools and High Schools in diverse educational sectors. The program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the Ministries of Defense and Social Welfare, the National Insurance Institute, the National Electric Corporation and in many other public and private frameworks.
The proposed study is aimed to assess whether the Michael Method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Michael Method | Experimental | Behavioral: Michael Method14 group meeting, taking place once a week during 14 consecutive weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Type 1 Diabetes at least 1 year prior to study inclusion
- 12-17 years old
- HbA1c > 7.8%
Key exclusion criteria (1 listed)
- Incapability to comply with all study requirements
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 |
|---|---|---|
| Michael Method | Behavioural | Michael Method |
Primary outcome
Metabolic Control measured as HbA1c level
Time frame: at the end of the study - after 15 weeks
4 secondary outcomes
Diabetes Quality of Life questionnaire (DQOLY)
Time frame: At the end of the study- after 15 weeks
Self assessment questionnaire
Time frame: At the end of the study- after 15 weeks
Number of severe hypoglycemic events
Time frame: at the end of the study-after 15 weeks
Number of Diabetic Keto Acidosis events
Time frame: at the end of the study- after 15 weeks
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 1 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Michael Method in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 1 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 1 May 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 Israel. 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?
Metabolic Control measured as HbA1c level (time frame: at the end of the study - after 15 weeks). 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 1 May 2014.