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