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Efficacité et rentabilité des programmes de prévention du diabète entièrement automatisés, numériques ou humains

3 novembre 2026 mis à jour par: Johns Hopkins University

The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.

Aperçu de l'étude

Description détaillée

After being informed about the study and potential risk, all participants giving written informed consent will undergo screening to determine eligibility for study entry. At baseline visit (month 0). Participants who meet the eligibility requirements will be randomly assigned in 1:1 ratio to human coach-based diabetes prevention program or digital diabetes prevention program. An equal number of participants will be randomly assigned to both groups (like flipping a coin).

If participants are randomly assigned to receive the human coach-based diabetes prevention program, the participants will be referred to a local Diabetes Prevention Program close to the participants' area. The Diabetes Prevention Program consists of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.

If participants are randomly assigned to receive the digital Diabetes Prevention Program, the participants will receive the Sweetch Digital Health Kit (Sweetch Health, Ltd.) in the mail within approximately 8-12 days of the participants' first study visit. The Sweetch digital health kit consists of a smartphone app and a digital body weight scale that is connected via Bluetooth to the app. The phone app also consists of brief Centers for Disease Control and Prevention (CDC) lessons on type 2 diabetes prevention, which participants will be encouraged to complete.

There will be a total of 3 study visits (baseline, 6 months, and 12 months), each visit includes fingerstick hemoglobin A1C measurement, weight measurement, and completion of several questionnaires. Height will be measured at the first visit. Throughout the 12-month study, participants will be asked to wear a device on the participants' wrist to measure physical activity for 7 consecutive days following the first visit and once every month thereafter.

Type d'étude

Interventionnel

Inscription (Réel)

368

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Baltimore, Maryland, États-Unis, 21287
        • Johns Hopkins Hospital
    • Pennsylvania
      • Reading, Pennsylvania, États-Unis, 19611
        • Reading Hospital - Tower Health

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Provision of signed and dated informed consent form.

  • Stated willingness to comply with all study procedures and availability for the duration of the study.

  • Laboratory evidence of prediabetes, defined as any of the following lab results, in the past year:

    1. Hemoglobin A1C 5.7% to 6.4%
    2. Fasting glucose 100-125 mg/dL
    3. Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load
  • Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians).

  • Proficiency in reading English.

  • Smartphone user (Android Operating System (OS) 9.0 or iOS 13.3 or newer).

  • Plans to reside in recruitment area for the next 12 months (participant's zip code of residence is within ~45 miles of the study recruitment site.

Exclusion Criteria:

  • Medical conditions that prevent adoption of moderate physical activity (per primary care clinician).
  • Aortic stenosis.
  • Unstable cardiac disease (myocardial infarction, heart failure, or stroke in previous 6 months, currently participating in cardiac rehabilitation).
  • Has a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device.
  • Use of any glucose-lowering medications, weight loss medications, or any systemic glucocorticoids within the previous 3 months.
  • Active malignancy of any type or diagnosed with or treated for cancer within the past 2 years. Individuals with basal and squamous cell carcinoma of the skin that has been successfully treated will be allowed to participate.
  • Diagnosis of diabetes mellitus.
  • Pregnancy or planned pregnancy in the next 12 months.
  • Anemia.
  • Receiving treatment for iron-deficiency anemia, vitamin B12 deficiency, or folate d efficiency.
  • Hemoglobinopathy (HbS or HbC disease).
  • Blood transfusion in previous 4 months.
  • On dialysis or active organ transplant list.
  • Treated with erythropoietin.
  • Major psychiatric disorder (schizophrenia) or use of antipsychotic medications within the past 1 year.
  • Dementia or Alzheimer's disease.
  • Diagnosed with an eating disorder (anorexia nervosa, avoidant/restrictive food intake disorder, binge eating disorder, bulimia nervosa, Pica, rumination disorder, other specified or unspecified feeding or eating disorder)
  • Diagnosed or self-reported alcohol or substance abuse.
  • Known allergy to steel.
  • Participation in another clinical trial related to lifestyle management or diabetes prevention.
  • Currently attending or attended a diabetes prevention program in the previous 2 years.
  • Unwilling to accept random assignments.
  • Had bariatric surgery within the 12 months prior randomization or is planning to undergo bariatric surgery during the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fully-Automated Digital Diabetes Prevention Program

Participants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app.

The Sweetch app is a hyper-personalized mobile digital coach that provides users with tailored recommendations to promote healthy lifestyle behaviors (150 minutes per week of physical activity, weight reduction, and healthy eating habits) to reduce the risk of type 2 diabetes.

The Sweetch app uses self-tracking and multiple evidence-based persuasive eCoaching strategies. The Sweetch artificial intelligence algorithm delivers just-in-time support and/or adapt recommendations based on the user's response. For example, push notifications will be sent when the algorithm detects that the user is potentially available and able to act upon the recommendation, based on various parameters including location, previous response, calendar availability, and weather, etc.

Comparateur actif: Human Coach-Based Diabetes Prevention Program

Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.

The Human Coach-Based Diabetes Prevention Program will consist of a CDC recognized lifestyle change program. Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)
Délai: 12 months

The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following:

  1. Weight loss of ≥5%.
  2. Weight loss of ≥4% combined with at least 150 weekly minutes of moderate-to-vigorous PA
  3. An absolute decrease of ≥0.2 points in A1C (measured in %). The A1C endpoint was applicable only to participants with baseline A1C of 5.7% to 6.4%. Maintaining an A1C <6.5% throughout the study was also a criterion for the primary outcome.
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Absolute Weight Change
Délai: At 12 months

Absolute weight change (kilograms) from baseline to 12 months

At 12 months
Cost-effectiveness as Assessed by the Markov Model
Délai: 12 months

The investigators will compare the cost-effectiveness of the two interventions based on lifetime horizon by constructing a Markov model with model parameters populated from the trial results as well as other published literature. The model will estimate the incremental cost-effectiveness ratio between the two interventions.

12 months
Change in Hemoglobin A1C
Délai: At 12 months

Change in HbA1C (percentage points) from baseline to 12 months (among participants with baseline HbA1C of 5.7% - 6.4% who completed the 12-month study visit).

At 12 months
Percentage Change in Weight
Délai: At 12 months

Percentage change in weight from baseline to 12 months

At 12 months
Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)
Délai: At 12 months

Average minutes/week of physical activity assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period). If the participant did not wear their monitor for at least 5 of their 7 assigned days, they were considered noncompliant. In this case, the participant was assigned 0 minutes for physical activity for that week.To obtain the average MVPA minutes per week across the study period, the total MVPA minutes per week from all valid wear periods were summed and divided by the number of available wear periods (maximum of 11 post-baseline visits). Specifically, activity intensity was classified as MVPA if the vector magnitude of accelerometer counts per minute was equal to or greater than 3941 (Montoye's cut point).

At 12 months
Incidence of Diabetes-range A1C
Délai: At either 6 or 12 months

Number of individuals who had an AIC in the diabetes range (A1C ≥6.5%) at the 6-month or 12-month timepoint.

At either 6 or 12 months
Acceptability as Assessed by the Diabetes Prevention Program Acceptability Scale (DPPAS)
Délai: 12 months

Acceptability of the assigned intervention was assessed at 12 months using the Diabetes Prevention Program Acceptability Scale (DPPAS), Score range from 1 to 5; higher scores indicate greater acceptability (better outcome).

12 months
Correlation Between Self-reported and Measured Physical Activity
Délai: 6 months and 12 months

To evaluate the correlation between self-reported PA data collected using different methods:

  • Data collected and reported by hDPPs
  • Self-reported PA data collected by study team obtained at 1-month intervals
  • Objectively measured PA data (Actigraphy) obtained at 1-month intervals
6 months and 12 months
Program Initiation Rate
Délai: At 12 months

Program initiators were defined as participants who attended at least one in-person session (Human-DPP) or registered and used the Sweetch app (AI-DPP).

At 12 months
Program Completion Rate
Délai: At 12 months

Program completers attended ≥8 sessions in months 1-6 and spanned ≥9 months (Human-DPP), or engaged with the app for ≥8 weeks during months 1-6 with a span of ≥9 months between initiation and last engagement (AI-DPP).

At 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Nestoras Mathioudakis, MD MHS, Johns Hopkins University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2021

Achèvement primaire (Réel)

16 décembre 2024

Achèvement de l'étude (Réel)

16 décembre 2024

Dates d'inscription aux études

Première soumission

14 septembre 2021

Première soumission répondant aux critères de contrôle qualité

23 septembre 2021

Première publication (Réel)

24 septembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The Data Coordinating Center (Johns Hopkins University) will prepare a de-identified database that is consistent with HIPAA requirements. The de-identified database will include all study research data and will be stored in a repository at Johns Hopkins University (archive.data.jhu.edu) at a time that will coincide with the online publication of the study primary endpoint paper. The repository will contain documentation designed to facilitate use of the database. The documentation prepared for the repository will include a list and timetable for secondary and exploratory papers planned by the study investigators. Access to the database will be restricted to qualified users. Qualified users will include those investigators who submit valid pre-specified hypotheses and certify that they will not use the data for commercial purposes.

Délai de partage IPD

The study protocol will be submitted for publication within 1 year of the start of enrollment.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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