Diabetes Mellitus, Type 2MinT2DNCT04935554
My Type 2 Diabetes: Person-centred Health Care
A study testing Person centred care in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Person centred care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- 17 Aug 2020to 31 Dec 2022
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
Who cannot join
- Unstable cardiovascular disease
- Severe chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
About this study
The Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.
Read the detailed description
Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a high individual effort, which can be demanding. Good mental health is necessary to be able to manage and control diabetes in a healthy and effective way. Therefore, we want to create an offer that takes care of the whole person, and physically as well as mentally.
Personal follow-up Based on surveys and conversations, the study participant and a contact person will prepare a 12-week plan that will be implemented with self-measurements and follow-up from the contact person. The plan will consist of the activities that best suit the participant's needs. It can be physical activity, diet course, health competence, motivation and psychosocial intervention that will be useful for the participant. After 12 weeks, the implementation will be evaluated.
Several new technological solutions are developed and will be used during the project period. A digital tool for mapping of the individuals needs will be an important part of the survey that is done during start-up. Activity clocks will be used for measuring steps, heart rate, and number of personalized activity index (PAI). An online portal for communication and interaction will make information easily accessible to users, simplify distance follow-up and communication flow.
The intervention will take place at two Healthy Life Centres. A Healthy Life Centre is an interdisciplinary primary health care service which offers effective, knowledge-based measures for people with, or in high risk of disease, who need support in health behaviour change and in coping health problems and chronic disease.
The Healthy Life Centre is part of the public health care service in the municipality. Healthy Life Centre programs have a patient centred approach and aim at strengthening the individual's control of his or her own health.
The intervention study starts in two municipalities in Møre og Romsdal, and the goal is to make the offer national.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Person centred 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.
Person centred careOther
physical activity, nutrition, motivation, health competence, psychosocial.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Baseline testing with blood samples, blood pressure and 6 minute walking test. After answering a comprehensive screening tool questionnaire and a conversation with a resource person about "What is important to you", the study participant will chose one or several of the following interventions: physical activity, nutrition, motivation, health competence, psychosocial. Receives: Other: Person centred care |
| Control | No intervention | Baseline testing with blood samples, blood pressure, 6 minute walking test and screening tool questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated haemoglobin (HbA1c) from baseline until week 12
Glycated haemoglobin (HbA1c) is a measurement of the three-month average blood sugar level and HbA1c is an important outcome measure in diabetes clinical trials.
Measured: Baseline and week 12
Secondary outcomes (4)
Change in waist circumference from baseline until week 12
Waist circumference is a simple method to assess abdominal adiposity that is easy to standardize and clinically apply. Waist circumference is strongly associated with all-cause and cardiovascular mortality
Measured: Baseline and week 12
Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12
Personalized activity index (PAI) was derived from an algorithm from one of the world's largest health studies (HUNT) and is a single, easy-to-understand personalized activity tracking metric that can help everyday people manage their health. Maintaining 100 PAI or more per week is strongly associated with adding on average 5 years to your life and reducing the risk of cardiovascular disease mortality by an average of 25%.
Measured: Baseline and week 12
Health competence
The short version (HLS-Q12 ) of the European Health Literacy Survey Questionnaire (HLS-EU-Q47)
Measured: Baseline and week 12
Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) until week 12
The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire) published by the Clinical Assessment division of the Pearson Assessment \& Information group. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. SCL-90r is useful in measuring patient progress or treatment outcomes.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start17 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Centre for Health Innovation, The Dam Foundation
- Responsible party
- Sponsor
- Investigators
- Charlotte Ingul, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935554
- Sponsor's protocol ID
- 123998
- Acronym
- MinT2D
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2020
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Type 2 Diabetes: Person-centred Health Care
- ClinicalTrials.gov ID
- NCT04935554
- Acronym / sponsor ID
- MinT2D / 123998
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Centre for Health Innovation, The Dam Foundation
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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 Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.
Detailed description
Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a high individual effort, which can be demanding. Good mental health is necessary to be able to manage and control diabetes in a healthy and effective way. Therefore, we want to create an offer that takes care of the whole person, and physically as well as mentally.
Personal follow-up Based on surveys and conversations, the study participant and a contact person will prepare a 12-week plan that will be implemented with self-measurements and follow-up from the contact person. The plan will consist of the activities that best suit the participant's needs. It can be physical activity, diet course, health competence, motivation and psychosocial intervention that will be useful for the participant. After 12 weeks, the implementation will be evaluated.
Several new technological solutions are developed and will be used during the project period. A digital tool for mapping of the individuals needs will be an important part of the survey that is done during start-up. Activity clocks will be used for measuring steps, heart rate, and number of personalized activity index (PAI). An online portal for communication and interaction will make information easily accessible to users, simplify distance follow-up and communication flow.
The intervention will take place at two Healthy Life Centres. A Healthy Life Centre is an interdisciplinary primary health care service which offers effective, knowledge-based measures for people with, or in high risk of disease, who need support in health behaviour change and in coping health problems and chronic disease.
The Healthy Life Centre is part of the public health care service in the municipality. Healthy Life Centre programs have a patient centred approach and aim at strengthening the individual's control of his or her own health.
The intervention study starts in two municipalities in Møre og Romsdal, and the goal is to make the offer national.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Person centred careBaseline testing with blood samples, blood pressure and 6 minute walking test. After answering a comprehensive screening tool questionnaire and a conversation with a resource person about "What is important to you", the study participant will chose one or several of the following interventions: physical activity, nutrition, motivation, health competence, psychosocial. |
| Control | No intervention | –Baseline testing with blood samples, blood pressure, 6 minute walking test and screening tool questionnaire. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes
Key exclusion criteria (2 listed)
- Unstable cardiovascular disease
- Severe chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| Person centred carephysical activity, nutrition, motivation, health competence, psychosocial. | Other | Intervention |
Primary outcome
Change in Glycated haemoglobin (HbA1c) from baseline until week 12
Time frame: Baseline and week 12
Glycated haemoglobin (HbA1c) is a measurement of the three-month average blood sugar level and HbA1c is an important outcome measure in diabetes clinical trials.
4 secondary outcomes
Change in waist circumference from baseline until week 12
Time frame: Baseline and week 12
Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12
Time frame: Baseline and week 12
Health competence
Time frame: Baseline and week 12
Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) until week 12
Time frame: Baseline and week 12
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 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Charlotte Ingul, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person centred care in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 2 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 5 Jun 2024. 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 Norway. 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?
Change in Glycated haemoglobin (HbA1c) from baseline until week 12 (time frame: Baseline and week 12). 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 5 Jun 2024.