Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on Glycemic Control in Patients With Type 2 Diabetes.

NCT07079189 | Recruiting

• 1 other identifier: Lifestyle tool LLM in diabetes
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. 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

Diabetes Mellitus (Type 2)

Outcome Measures

Primary Outcomes (1)

• Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year

  Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 1 year relative to baseline compared between participants with access to the tool and on standard care.

  1 year

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: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment with insulin
• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Clinical Research Center

Malmo, 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

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitta Abrahamsson

CONTACT

+46705316704; birgitta.x.abrahamsson@skane.se

Study Design

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

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication.
• 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)