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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Informed consent

Age above 35 years

Access to Internet and mobile or computer device

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyle tool

    Behavioral

    Regular use of the digital Lifestyle tool

Treatment groups

40,000 Participants
are divided into 2 treatment groups
Group A: Lifestyle interventionExperimental treatment 1 intervention
Group B: Controls on standard careNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Göteborg University

Collaborator