Diabetes Type 2PREVAILNCT07661381
An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.
A study testing Lifestyle program, Lifestyle program + coach and Lifestyle program + coach + CGM in people with Diabetes Type 2, run by University of Twente at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Lifestyle program, Lifestyle program + coach and Lifestyle program + coach + CGM
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University of Twente
Enschede, Overijssel, 7500 AE
Lotte G.P. Peters, MSc, +31534891403, lotte.peters@utwente.nl
Lotte G.P. Peters, MSc
About this study
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."
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.
Read the detailed description
Rationale: An estimated 400,000 individuals in the Netherlands are living with undiagnosed type 2 diabetes (T2D), in addition to 1.1 million diagnosed cases. Unhealthy lifestyle behaviours are a major contributing factor. Intensive lifestyle interventions and Continuous Glucose Monitoring (CGM) have demonstrated effectiveness in improving health behaviour and glycaemic control. Digital health technologies, including personalised digital interventions and virtual coaching enable continuous, scalable and context-specific support, thereby facilitating sustained behaviour change and improved self-management. Remote lifestyle interventions are therefore promising and may enhance self-management and glycaemic control, reduce medicine use and delay the development of comorbidities and diabetes-related complications. This study evaluates a remote, personalised lifestyle program combining online group sessions, peer support, CGM use, and a virtual AI lifestyle coach for individuals living with T2D.
Objective: The objective of this study is to evaluate the added value of CGM, biofeedback and a virtual AI lifestyle coach providing personalised, data-driven support within a first prototype of a remote lifestyle intervention for adults with T2D. Specifically, this pilot randomized controlled trial aims to assess the incremental effects of CGM, biofeedback and AI supported personalised coaching, informed by glucose data, demographics, behaviour, goals and preferences on health behaviours and glycaemic control over a 12-month period with two follow-up measurements.
Study design: This three-arm parallel-group randomized controlled trial includes:
- A lifestyle program consisting of online group sessions and a peer support community.
- The same lifestyle program supplemented with a virtual AI lifestyle coach.
- The AI-supported program with four times CGM use.
Study population: Adults (n=160) with T2D (HbA1c ≥53 mmol/mol) without glucose lowering medication (except Metformin), both men and women from all ethnic backgrounds.
Intervention: Participants complete an online baseline questionnaire and a brief in-app intake prior to randomization. All participants attend online group sessions and may engage with peers via the online community. The AI lifestyle coach uses the baseline data to have personalised coaching conversations with the participant throughout the intervention. In the third arm, real-time CGM data are additionally integrated into the AI-driven personalisation process.
Main study parameters/endpoints: The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include changes in physiological (e.g. body weight), clinical (e.g. time in range), behavioural (e.g. dietary intake), and psychological (e.g. quality of life) outcomes.
- Conditions
- Diabetes Type 2
- Being tested
- Lifestyle program, Lifestyle program + coach, Lifestyle program + coach + CGM
- Keywords
- Lifestyle intervention, Artificial intelligence, Remote study, Dietary intake, Continuous glucose monitoring, Lifestyle coach
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle programBehavioural
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.
Lifestyle program + coachDevice
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.
Lifestyle program + coach + CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Lifestyle program (control group) Receives: Behavioral: Lifestyle program |
| Arm 2 | Experimental | Lifestyle program + coach Receives: Device: Lifestyle program + coach |
| Arm 3 | Experimental | Lifestyle program + coach + CGM Receives: Device: Lifestyle program + coach + CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.
Measured: From the beginning of the study to the end of the study at 12 months
Secondary outcomes (10)
Change in body weight
Measured: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in blood pressure
Systolic and diastolic blood pressure
Measured: From the beginning of the study to the end of the study (12 months)
Change in medication use
Measured: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in waist and hip circumference
Measured: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in habitual dietary intake assessed with the Nutri+ instrument
Measured: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in glycaemic regulation assessed with CGM and blood sample
Measured: From the beginning of the study to the end of the study (12 months)
Change in albumin-creatinine ratio
Urine sample
Measured: From the beginning of the study to the end of the study (12 months)
Study evaluation
Dutch System Usability Scale (SUS). Ten questions on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater overall usability of the system being studied.
Measured: Once at the end of the study at 12 months
Tailoring
Success in Tailoring (SIT) scale. Eight items on a 5-point Likert-scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater perceived individual tailoring of the information.
Measured: Once at the end of the study at 12 months
Change in quality of life
Health-related quality of life (EQ-5D). It assigns a score across five health dimensions, from "I have no problems..." to "I am unable to...". The higher the score, the better the quality of life.
Measured: At the start of the study and at the two follow-up measurements at 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three intervention arms.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Collaborators
- TNO
- Responsible party
- Principal investigator, Lotte Peters, University of Twente
- Investigators
- Goos D. Laverman, Prof. Dr., Principal investigator, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661381
- Sponsor's protocol ID
- NL011950
- Other IDs
- NL011950
- Acronym
- PREVAIL
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT07661381
- Acronym / sponsor ID
- PREVAIL / NL011950
- Conditions
- Diabetes Type 2
- Keywords
- Lifestyle intervention, Artificial intelligence, Remote study, Dietary intake, Continuous glucose monitoring, Lifestyle coach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Collaborators
- TNO
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: An estimated 400,000 individuals in the Netherlands are living with undiagnosed type 2 diabetes (T2D), in addition to 1.1 million diagnosed cases. Unhealthy lifestyle behaviours are a major contributing factor. Intensive lifestyle interventions and Continuous Glucose Monitoring (CGM) have demonstrated effectiveness in improving health behaviour and glycaemic control. Digital health technologies, including personalised digital interventions and virtual coaching enable continuous, scalable and context-specific support, thereby facilitating sustained behaviour change and improved self-management. Remote lifestyle interventions are therefore promising and may enhance self-management and glycaemic control, reduce medicine use and delay the development of comorbidities and diabetes-related complications. This study evaluates a remote, personalised lifestyle program combining online group sessions, peer support, CGM use, and a virtual AI lifestyle coach for individuals living with T2D.
Objective: The objective of this study is to evaluate the added value of CGM, biofeedback and a virtual AI lifestyle coach providing personalised, data-driven support within a first prototype of a remote lifestyle intervention for adults with T2D. Specifically, this pilot randomized controlled trial aims to assess the incremental effects of CGM, biofeedback and AI supported personalised coaching, informed by glucose data, demographics, behaviour, goals and preferences on health behaviours and glycaemic control over a 12-month period with two follow-up measurements.
Study design: This three-arm parallel-group randomized controlled trial includes:
- A lifestyle program consisting of online group sessions and a peer support community.
- The same lifestyle program supplemented with a virtual AI lifestyle coach.
- The AI-supported program with four times CGM use.
Study population: Adults (n=160) with T2D (HbA1c ≥53 mmol/mol) without glucose lowering medication (except Metformin), both men and women from all ethnic backgrounds.
Intervention: Participants complete an online baseline questionnaire and a brief in-app intake prior to randomization. All participants attend online group sessions and may engage with peers via the online community. The AI lifestyle coach uses the baseline data to have personalised coaching conversations with the participant throughout the intervention. In the third arm, real-time CGM data are additionally integrated into the AI-driven personalisation process.
Main study parameters/endpoints: The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include changes in physiological (e.g. body weight), clinical (e.g. time in range), behavioural (e.g. dietary intake), and psychological (e.g. quality of life) outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Lifestyle programLifestyle program (control group) |
| Arm 2 | Experimental | Device: Lifestyle program + coachLifestyle program + coach |
| Arm 3 | Experimental | Device: Lifestyle program + coach + CGMLifestyle program + coach + CGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle programParticipants 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. | Behavioural | Arm 1 |
| Lifestyle program + coachIdem 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 | Arm 2 |
| Lifestyle program + coach + CGMIdem 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. | Device | Arm 3 |
Primary outcome
Change in HbA1c levels
Time frame: From the beginning of the study to the end of the study at 12 months
The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.
10 secondary outcomes
Change in body weight
Time frame: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in blood pressure
Time frame: From the beginning of the study to the end of the study (12 months)
Change in medication use
Time frame: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in waist and hip circumference
Time frame: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in habitual dietary intake assessed with the Nutri+ instrument
Time frame: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
Change in glycaemic regulation assessed with CGM and blood sample
Time frame: From the beginning of the study to the end of the study (12 months)
Change in albumin-creatinine ratio
Time frame: From the beginning of the study to the end of the study (12 months)
Study evaluation
Time frame: Once at the end of the study at 12 months
Tailoring
Time frame: Once at the end of the study at 12 months
Change in quality of life
Time frame: At the start of the study and at the two follow-up measurements at 18 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Goos D. Laverman, Prof. Dr. principal investigator
University of Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle program, Lifestyle program + coach and Lifestyle program + coach + CGM in people with Diabetes Type 2, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lotte G.P. Peters, MSc (+31534891403, lotte.peters@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels (time frame: From the beginning of the study to the end of the study at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.