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

NCT07659535 | Recruiting

• 1 other identifier: Lifestyle tool LLM
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Participants get access to the Lifestyle tool and use it regularly

Behavioral: Lifestyle tool

Controls on standard care

NO INTERVENTION

Participants who get randomized to control cannot access the tool.

Interventions

Lifestyle tool BEHAVIORAL

Regular use of the digital Lifestyle tool

Lifestyle intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Göteborg University: collaborator

Study Sites (1)

Clinical Research Center

Malmö, Skåne County, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anders Rosengren, MD PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitta Abrahamsson, MSc

CONTACT

0705316704; birgitta.x.abrahamsson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants get access to the tool or get assigned to a control group without access.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Access Criteria: To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to livsstilsverktyget@gu.se

Locations

SE (1)