Diabetes Mellitus (Type 2)NCT07079189
Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on Glycemic Control in Patients With 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
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 11 Aug 2025to 1 Dec 2027
- 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
- Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
- age at or above 35 years
- access to Internet
- informed consent
Who cannot join
- Treatment with insulin
- Change of anti-diabetic treatment with three months prior to inclusion
- Participation in other study that may affect the outcomes
- Condition or treatment that in the judgement of the Investigator precludes participation
- Inability to read and write in Swedish
- Work in competing areas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Research Center
Malmö, Skåne County, 20502
Anders Rosengren, MD PhD, 0705316704, anders.rosengren@gu.se
Anders Rosengren, MD PhD
About this study
Official title: Personalized Study of Type 2 Diabetes With the Lifestyle Tool
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. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.
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, few 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. The investigators have previously shown that the digital Livsstilsverktyget ('Lifestyle tool') developed at the University of Gothenburg leads to improved glycemic controls in patients using it regularly (Dwibedi et al., npj Digital Medicine 2022). To make the intervention more personal the investigators have coupled it with a large language model (LLM) to promote reflection on the expert-written content of the Lifestyle tool. Thus, participants interact with the LLM to explore a current area of interest. They then get recommendations from the LLM on relevant texts from the Lifestyle tool. These texts are written by experts (physicians, researchers). The participants go through the text and are then stimulate by the LLM to reflect on how to use the content in daily life.
Study participants with type 2 diabetes will be randomized to the intervention 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 intervention.
Blood samples are drawn for analysis of glycated hemoglobin (HbA1c), a measure of glucose control, at baseline, after six months and after twelve months. Blood samples are drawn at their primary care unit. 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 Lifestyle 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 standard 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 posted22 Jul 2025
- Study start11 Aug 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion1 Dec 2027 (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 2)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Rosengren, MD PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079189
- Sponsor's protocol ID
- Lifestyle tool LLM in diabetes
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 14 Aug 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Study of Type 2 Diabetes With the Lifestyle Tool
- ClinicalTrials.gov ID
- NCT07079189
- Acronym / sponsor ID
- Lifestyle tool LLM in diabetes
- Conditions
- Diabetes Mellitus (Type 2)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jul 2025 (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. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.
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, few 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. The investigators have previously shown that the digital Livsstilsverktyget ('Lifestyle tool') developed at the University of Gothenburg leads to improved glycemic controls in patients using it regularly (Dwibedi et al., npj Digital Medicine 2022). To make the intervention more personal the investigators have coupled it with a large language model (LLM) to promote reflection on the expert-written content of the Lifestyle tool. Thus, participants interact with the LLM to explore a current area of interest. They then get recommendations from the LLM on relevant texts from the Lifestyle tool. These texts are written by experts (physicians, researchers). The participants go through the text and are then stimulate by the LLM to reflect on how to use the content in daily life.
Study participants with type 2 diabetes will be randomized to the intervention 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 intervention.
Blood samples are drawn for analysis of glycated hemoglobin (HbA1c), a measure of glucose control, at baseline, after six months and after twelve months. Blood samples are drawn at their primary care unit. 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 Lifestyle 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 (5 listed)
- Patients with type 2 diabetes
- Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
- age at or above 35 years
- access to Internet
- informed consent
Key exclusion criteria (6 listed)
- Treatment with insulin
- Change of anti-diabetic treatment with three months prior to inclusion
- Participation in other study that may affect the outcomes
- Condition or treatment that in the judgement of the Investigator precludes participation
- Inability to read and write in Swedish
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 standard 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 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be shared after deidentification.
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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.
Anders Rosengren, MD PhD 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Aug 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?
Contact Birgitta Abrahamsson (+46705316704, birgitta.x.abrahamsson@skane.se), or a site near the patient. 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 14 Aug 2025.