Type 2 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALLifestyle tool
Regular use of the digital Lifestyle tool
Sponsors
Region Skane
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants get access to the tool or get assigned to a control group without access.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of type 2 diabetes | 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. |
Countries
Sweden
Contacts
CONTACTBirgitta Abrahamsson, MSc
PRINCIPAL_INVESTIGATORAnders Rosengren, MD PhD
Göteborg University
Outcome results
None listed