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[Essai d'un dispositif non approuvé ou autorisé par la FDA américaine] (INSIGHT)

17 juin 2026 mis à jour par: Sue Brown

[Essai d'un dispositif non approuvé ni autorisé par la FDA américaine]

This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.

Aperçu de l'étude

Description détaillée

The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).

The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.

Type d'étude

Interventionnel

Inscription (Estimé)

20

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.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Virginia
      • Charlottesville, Virginia, États-Unis, 22903
        • Recrutement
        • University of Virginia Center for Diabetes Technology
        • Sous-enquêteur:
          • Mark DeBoer, MD
        • Sous-enquêteur:
          • Samina Afreen, MD
        • Sous-enquêteur:
          • Marcela Moscoso-Vasquez, PhD
        • Contact:
        • Sous-enquêteur:
          • Driscoll Kimberly, PhD

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Participant Inclusion Criteria

  1. Age ≥18.0 years old at time of consent
  2. Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
  3. Having used an FDA approved AID system within the last 6 months (can be intermittent use).
  4. Currently using insulin for >6 months.
  5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
  6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
  7. Participant not currently known to be pregnant or breastfeeding.
  8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  9. Willingness to wear a Dexcom CGM during each of the study phases.
  10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
  11. Willingness not to start any new non-insulin glucose-lowering agent during the trial.
  12. Willingness to participate in all study procedures including in person training.
  13. Access to internet at home and willingness to upload data during the study as needed.
  14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.
  15. Participant is proficient in reading and verbal communication in English.

Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.

  1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
  2. Current use of sulfonylurea medications.
  3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
  4. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
  5. Hemophilia or any other bleeding disorder.
  6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
  7. History of DKA event in the last 12 months.
  8. Currently on peritoneal or hemodialysis.
  9. Currently being treated for adrenal insufficiency.
  10. Currently being treated for a seizure disorder.
  11. Hypothyroidism or hyperthyroidism that is not adequately treated.
  12. Use of oral or injectable steroids at the time of enrollment.
  13. Known ongoing adhesive intolerance that is not well managed.
  14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
  15. Participation in another interventional trial at the time of enrollment.
  16. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
Comparateur actif: Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time in range 70-140 mg/dL as computed by the study CGM
Délai: 8 weeks
Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
8 weeks
Time in range 70-140 mg/dL as computed by the study CGM
Délai: 8 weeks

Outcome is computed if:

  • >4032 values are recorded (availability condition, 2 weeks equivalent)
  • AND there is >70% values between the first recorded EGV of the analysis window and the last (density condition)
8 weeks

Collaborateurs et enquêteurs

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

Parrainer

Les enquêteurs

  • Chercheur principal: Sue A Brown, MD, University of Virginia Center for Diabetes Technology

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)

14 mai 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

27 mars 2026

Première soumission répondant aux critères de contrôle qualité

27 mars 2026

Première publication (Réel)

2 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette 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

Oui

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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