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

22 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

160

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Holandia
    • Overijssel
      • Enschede, Overijssel, Holandia, 7500 AE
        • University of Twente
        • Kontakt:
        • Główny śledczy:
          • Lotte G.P. Peters, MSc

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Arm 1
Lifestyle program (control group)
Behawioralne: 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.
Eksperymentalny: Arm 2
Lifestyle program + coach
Urządzenie: 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.
Eksperymentalny: Arm 3
Lifestyle program + coach + CGM
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in HbA1c levels
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in body weight
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Socio-demographic characteristics
Ramy czasowe: At baseline
Socio-demographic characteristics obtained with the baseline questionnaire.
At baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Twente

Współpracownicy

TNO

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

16 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

22 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NL011950 (Inny identyfikator: Central Committee on Research Involving Human Subjects)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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