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Not Yet Recruiting NCT07661381

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

Conditions: Diabetes Type 2

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: University of Twente

Location: University of Twente Enschede Overijssel

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.

Eligibility Criteria

Inclusion Criteria: * Age: ≥18 years * HbA1c: ≥53 mmol/mol (7 - 12%) * Signed informed consent form and willing to comply with the study procedures * Persons who are naïve for participation in a lifestyle program for the past two years * Being digitally competent * Mastering the Dutch language * Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years) Exclusion Criteria: * Medication use: any other glucose-lowering medication than metformin * Comorbidities or medical conditions requiring a special diet that conflicts with the study * Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight) * Circumstances that lead to unreliable HbA1c values, such as blood donation * Pregnant or lactating women

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07661381). StuddyBuddy aggregates publicly available trial information.