Type 2 DiabetesNCT07659535
Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on the Prevention of Type 2 Diabetes
A study testing Lifestyle tool in people with Type 2 Diabetes, run by Region Skane at 1 site in Sweden.
Trial summary
The overall aim of the study is to investigate the incidence of type 2 diabetes in individuals who have access to a digital intervention tool as compared with randomized controls during three years. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- 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
- 40,000 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2026to 31 Dec 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Age above 35 years
- Access to Internet and mobile or computer device
Who cannot join
- diabetes mellitus
- 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.
- living outside of Sweden
- inability to read and write in Swedish
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@gu.se
About this study
Official title: Personalized Study With the Lifestyle Tool
The overall aim of the study is to investigate the incidence of type 2 diabetes in individuals who have access to a digital intervention tool as compared with randomized controls during three years. 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
New scalable means to prevent type 2 diabetes is needed. AI-based large language models enable new means to support people in lifestyle changes. It is, however, important that these are coupled with serious health information.
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. 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.
This study will recruit people without type 2 diabetes, aged 35 years or older, from the general population. They will be randomly assigned to the intervention or to a control group without access to the intervention. The primary outcome is the incidence type 2 diabetes during three years. The primary variable, diagnosis of type 2 diabetes, is obtained via national health registers. Thus, no physical visits or blood sampling are required. The participants will complete the Findrisc questionnaire online at baseline to assess the risk for type 2 diabetes and enable effect analysis of individuals with different risk.
The study is an investigator-initiated single-center study conducted over three years. 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
- Type 2 Diabetes
- 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.
Incidence of type 2 diabetes
Incidence of type 2 diabetes diagnosed in routine care and reported in national clinical registers, i.e. defined as random plasma glucose >11.1 mmol/L or fasting glucose >7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using the tool and on usual care.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants get access to the tool or get assigned to a control group without access.
- Masking
- None (open label)
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Anders Rosengren, MD PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659535
- Sponsor's protocol ID
- Lifestyle tool LLM
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Study With the Lifestyle Tool
- ClinicalTrials.gov ID
- NCT07659535
- Acronym / sponsor ID
- Lifestyle tool LLM
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jun 2026 (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 investigate the incidence of type 2 diabetes in individuals who have access to a digital intervention tool as compared with randomized controls during three years. 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
New scalable means to prevent type 2 diabetes is needed. AI-based large language models enable new means to support people in lifestyle changes. It is, however, important that these are coupled with serious health information.
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. 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.
This study will recruit people without type 2 diabetes, aged 35 years or older, from the general population. They will be randomly assigned to the intervention or to a control group without access to the intervention. The primary outcome is the incidence type 2 diabetes during three years. The primary variable, diagnosis of type 2 diabetes, is obtained via national health registers. Thus, no physical visits or blood sampling are required. The participants will complete the Findrisc questionnaire online at baseline to assess the risk for type 2 diabetes and enable effect analysis of individuals with different risk.
The study is an investigator-initiated single-center study conducted over three years. 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants get access to the tool or get assigned to a control group without access.
| 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Age above 35 years
- Access to Internet and mobile or computer device
Key exclusion criteria (5 listed)
- diabetes mellitus
- 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.
- living outside of Sweden
- 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
Incidence of type 2 diabetes
Time frame: 3 years
Incidence of type 2 diabetes diagnosed in routine care and reported in national clinical registers, i.e. defined as random plasma glucose >11.1 mmol/L or fasting glucose >7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using 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 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be shared after deidentification.
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.
Anders Rosengren, MD PhD principal investigator
Göteborg University
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 Type 2 Diabetes, 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 3 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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, MSc (0705316704, 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?
Incidence of type 2 diabetes (time frame: 3 years). 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 25 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.