Diabetes Mellitus, Type 2NCT05679115
Evaluation of Lifestyle Tool in Type 2 Diabetes
A study testing Lifestyle tool in people with Diabetes Mellitus, Type 2, run by Region Skane at 1 site in Sweden.
Trial summary
The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes at or above 35 years of age
- HbA1C at 52 mmol/mol or above
- Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
- written informed consent.
Who cannot join
- type 1 diabetes, MODY or secondary diabetes
- conditions or treatments that in the judgement of the Investigator could affect the study evaluation
- connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of the Lifestyle Tool in Individuals With Type 2 Diabetes
The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. .
Read the detailed description
Type-2 diabetes afflicts more than 300 million people worldwide and poses a heavy burden on the healthcare systems everywhere. Recent guidelines from the American Diabetes Association and the European Association for the Study of Diabetes recommend enhanced focus on lifestyle management in addition to glucose-lowering drugs. Individual or group-based diabetes education programs can improve glucose control and quality-of-life, but they are resource-intense and long-term outcomes are variable. Moreover, less than one out of ten individuals with diabetes attend such programs because of practical, medical and financial hurdles to attend sessions.
Consequently, there is a large need for complementary lifestyle support that can meet individual preferences in content and timing and reach many patients at low cost. Digital tools have considerable potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy (>6 months) are scarce. Second, they are often combined with coaching or intensified healthcare contacts, making it difficult to specifically assess the effect of the digital component and apply the results to a broad range of settings with variations in structure and resources. Third, it is unclear how they affect concrete behaviours such as physical activity and physiological measures of insulin resistance and insulin secretion.
The investigators have developed a self-managed lifestyle tool that is based on a new approach combining health information with structured self-reflection to effectively promote behavioural change. The tool is digital, does not require additional healthcare resources and could be used for large numbers of patients in a scalable manner.
Study participants with type 2 diabetes will now be randomized to access the tool and the change of long-term blood glucose from baseline to end of follow-up will be compared with participants who are randomized to a control group without access to the tool.
Participants attend study visits every three months for blood sampling. Study personnel are instructed to remain neutral at blood sampling visits and not reinforce usage in order to assess the frequency of use and resultant outcomes that can be expected in real-life situations over extended time without the need for increased healthcare support. Technical problems are referred to a study coordinator, who also responded to requests to clarify content in a general manner without providing personal advice.
Study participants are managed by their ordinary healthcare providers throughout the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle tool
- 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.
Lifestyle toolBehavioural
Regular use of the digital Lifestyle tool
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Participants get access to the tool and use it regularly Receives: Behavioral: Lifestyle tool |
| Controls on standard care | No intervention | Participants who get randomized to control cannot access the tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 1 year relative to baseline compared between participants with access to the tool and on usual care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start10 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Region SkaneThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Rosengren, Professor, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679115
- Sponsor's protocol ID
- HealthDiabetes2
- Status last verified
- Jul 2025
- First submitted
- 29 Dec 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of the Lifestyle Tool in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05679115
- Acronym / sponsor ID
- HealthDiabetes2
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Jan 2023 (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 overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. .
Detailed description
Type-2 diabetes afflicts more than 300 million people worldwide and poses a heavy burden on the healthcare systems everywhere. Recent guidelines from the American Diabetes Association and the European Association for the Study of Diabetes recommend enhanced focus on lifestyle management in addition to glucose-lowering drugs. Individual or group-based diabetes education programs can improve glucose control and quality-of-life, but they are resource-intense and long-term outcomes are variable. Moreover, less than one out of ten individuals with diabetes attend such programs because of practical, medical and financial hurdles to attend sessions.
Consequently, there is a large need for complementary lifestyle support that can meet individual preferences in content and timing and reach many patients at low cost. Digital tools have considerable potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy (>6 months) are scarce. Second, they are often combined with coaching or intensified healthcare contacts, making it difficult to specifically assess the effect of the digital component and apply the results to a broad range of settings with variations in structure and resources. Third, it is unclear how they affect concrete behaviours such as physical activity and physiological measures of insulin resistance and insulin secretion.
The investigators have developed a self-managed lifestyle tool that is based on a new approach combining health information with structured self-reflection to effectively promote behavioural change. The tool is digital, does not require additional healthcare resources and could be used for large numbers of patients in a scalable manner.
Study participants with type 2 diabetes will now be randomized to access the tool and the change of long-term blood glucose from baseline to end of follow-up will be compared with participants who are randomized to a control group without access to the tool.
Participants attend study visits every three months for blood sampling. Study personnel are instructed to remain neutral at blood sampling visits and not reinforce usage in order to assess the frequency of use and resultant outcomes that can be expected in real-life situations over extended time without the need for increased healthcare support. Technical problems are referred to a study coordinator, who also responded to requests to clarify content in a general manner without providing personal advice.
Study participants are managed by their ordinary healthcare providers throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle toolParticipants get access to the tool and use it regularly |
| Controls on standard care | No intervention | –Participants who get randomized to control cannot access the tool. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes at or above 35 years of age
- HbA1C at 52 mmol/mol or above
- Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
- written informed consent.
Key exclusion criteria (3 listed)
- type 1 diabetes, MODY or secondary diabetes
- conditions or treatments that in the judgement of the Investigator could affect the study evaluation
- connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
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 |
|---|---|---|
| Lifestyle toolRegular use of the digital Lifestyle tool | Behavioural | Lifestyle intervention |
Primary outcome
Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year
Time frame: 1 year
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 1 year relative to baseline compared between participants with access to the tool and on usual care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be shared after deidentification.
Related trials for Diabetes Mellitus, Type 2
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.
Anders Rosengren, Professor principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle tool in people with Diabetes Mellitus, Type 2, run by Region Skane at 1 site in Sweden.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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 of long-term blood glucose concentration measured as glycated hemoglobin at 1 year (time frame: 1 year). 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 16 Jul 2025.