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

22 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Olanda
    • Overijssel
      • Enschede, Overijssel, Olanda, 7500 AE
        • University of Twente
        • Contatto:
        • Investigatore principale:
          • Lotte G.P. Peters, MSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm 1
Lifestyle program (control group)
Comportamentale: 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.
Sperimentale: Arm 2
Lifestyle program + coach
Dispositivo: 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.
Sperimentale: Arm 3
Lifestyle program + coach + CGM
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in HbA1c levels
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Socio-demographic characteristics
Lasso di tempo: At baseline
Socio-demographic characteristics obtained with the baseline questionnaire.
At baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Twente

Collaboratori

TNO

Investigatori

  • Investigatore principale: Goos D. Laverman, Prof. Dr., University of Twente

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL011950 (Altro identificatore: Central Committee on Research Involving Human Subjects)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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