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

June 22, 2026 updated by: Lotte Peters, University of Twente

"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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. A lifestyle program consisting of online group sessions and a peer support community.
  2. The same lifestyle program supplemented with a virtual AI lifestyle coach.
  3. 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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500 AE
        • University of Twente
        • Contact:
        • Principal Investigator:
          • Lotte G.P. Peters, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Lifestyle program (control group)
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.
Experimental: Arm 2
Lifestyle program + coach
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.
Experimental: Arm 3
Lifestyle program + coach + CGM
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning of the study to the end of the study at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 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
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
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 albumin-creatinine ratio
Time Frame: From the beginning of the study to the end of the study (12 months)
Urine sample
From the beginning of the study to the end of the study (12 months)
Change in blood pressure
Time Frame: From the beginning of the study to the end of the study (12 months)
Systolic and diastolic blood pressure
From the beginning of the study to the end of the study (12 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
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)
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
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.
Once at the end of the study at 12 months
Tailoring
Time Frame: Once at the end of the study at 12 months
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.
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
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.
At the start of the study and at the two follow-up measurements at 18 and 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic characteristics
Time Frame: At baseline
Socio-demographic characteristics obtained with the baseline questionnaire.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Twente

Collaborators

TNO

Investigators

  • Principal Investigator: Goos D. Laverman, Prof. Dr., University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL011950 (Other Identifier: Central Committee on Research Involving Human Subjects)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe