An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2… (NCT07661381) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.
Netherlands160 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1c levels
Timeframe: From the beginning of the study to the end of the study at 12 months