Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

22 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Nederland
    • Overijssel
      • Enschede, Overijssel, Nederland, 7500 AE
        • University of Twente
        • Contact:
        • Hoofdonderzoeker:
          • Lotte G.P. Peters, MSc

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm 1
Lifestyle program (control group)
Gedragsmatig: 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.
Experimenteel: Arm 2
Lifestyle program + coach
Apparaat: 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.
Experimenteel: Arm 3
Lifestyle program + coach + CGM
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HbA1c levels
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in body weight
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Socio-demographic characteristics
Tijdsspanne: At baseline
Socio-demographic characteristics obtained with the baseline questionnaire.
At baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Twente

Medewerkers

TNO

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL011950 (Andere identificatie: Central Committee on Research Involving Human Subjects)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren