Digital lifestyle program plus an AI chat helper to improve blood sugar in people with type 2 diabetes
Personalized Study of Type 2 Diabetes With the Lifestyle Tool
This project will try a web-based lifestyle program combined with an AI chat assistant to see if it helps adults with type 2 diabetes improve long-term blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Malmö, Skåne County) |
| Trial ID | NCT07079189 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares access to a digital Lifestyle tool coupled with a large language model (LLM) versus randomized controls over one year to measure changes in long-term metabolic control. Participants interact with expert-written lifestyle content and an LLM that prompts self-reflection and recommends relevant texts from the tool. Key eligibility includes adults aged 35 or older with type 2 diabetes, internet access, and the ability to read and write Swedish, while people treated with insulin or with recent medication changes are excluded. The primary outcome is change in glycemic control over 12 months at a single clinical research center in Malmö, Sweden.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 or older with established type 2 diabetes who are not on insulin, have internet access, can read and write Swedish, and can give informed consent.
Not a fit: Patients on insulin, those who recently changed anti-diabetic medications, people unable to read Swedish, or those without internet access are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined digital tool and AI assistant could help people with type 2 diabetes lower and maintain blood sugar with scalable, personalized lifestyle support and fewer in-person visits.
How similar studies have performed: Previous work with the Livsstilsverktyget digital tool showed improved glycemic control, but combining that tool with an LLM for personalized reflection is a novel approach that has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with type 2 diabetes * Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication * age at or above 35 years * access to Internet * informed consent Exclusion Criteria: * Treatment with insulin * Change of anti-diabetic treatment with three months prior to inclusion * Participation in other study that may affect the outcomes * Condition or treatment that in the judgement of the Investigator precludes participation * Inability to read and write in Swedish * Work in competing areas
Where this trial is running
Malmö, Skåne County
- Clinical Research Center — Malmö, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Anders Rosengren, MD PhD — Region Skane
- Study coordinator: Birgitta Abrahamsson
- Email: birgitta.x.abrahamsson@skane.se
- Phone: +46705316704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.