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NOT YET RECRUITING
NCT07661381
NA

An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.

Sponsor: University of Twente

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.

Official title: "An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes."

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Lifestyle program

Participants are asked to work on improving their lifestyle. They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm. Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.

DEVICE

Lifestyle program + coach

Idem to arm one, supplemented with a virtual AI lifestyle coach. The AI lifestyle coach can process all the information about the participant that was provided at baseline. This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant. During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan). The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions. The use of the AI lifestyle coach is an additional topic to the online group sessions.

DEVICE

Lifestyle program + coach + CGM

Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks. The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized. The use of CGMs is an additional topic to the online group sessions.

Locations (1)

University of Twente

Enschede, Overijssel, Netherlands