Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07659535

Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on the Prevention of Type 2 Diabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center

Malmö, Skåne County, 20502, Sweden

Location status: Recruiting

Location contact

Anders Rosengren, MD PhD

CONTACT

[email protected]

0705316704

Anders Rosengren, MD PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • Age above 35 years
  • Access to Internet and mobile or computer device

Exclusion criteria

  • 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

Treatment and study plan

Lifestyle tool

Behavioral

Regular use of the digital Lifestyle tool

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitta Abrahamsson, MSc

CONTACT

[email protected]

0705316704

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Göteborg University

Registry information

Official study title

Personalized Study With the Lifestyle Tool

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 22, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.