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Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes

12 novembre 2026 mis à jour par: Medtronic MiniMed, Inc.

This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The study is a multi-center, prospective single-arm design without controls for adult and pediatric subjects with T1D or T2D. The study is anticipated to last approximately 24 months from first investigational center initiation to study completion (last subject, last visit completed). The subject's participation from study enrollment to study exit is approximately up to 46 days (including replacement sensor wear and repeat office procedures if needed).

Type d'étude

Interventionnel

Inscription (Estimé)

1500

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

Lieux d'étude

  • États-Unis
    • California
      • Chula Vista, California, États-Unis, 91911
      • Escondido, California, États-Unis, 92025-6428
      • Palo Alto, California, États-Unis, 94304
        • Pas encore de recrutement
        • Stanford University
        • Contact:
        • Chercheur principal:
          • Rayhan Lal
      • San Diego, California, États-Unis, 92123
        • Pas encore de recrutement
        • Rady Children's Hospital - San Diego
        • Contact:
        • Chercheur principal:
          • Anna Cymbaluk
      • San Francisco, California, États-Unis, 94158
        • Pas encore de recrutement
        • University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
        • Contact:
        • Chercheur principal:
          • Laya Ekhlaspour
      • Santa Barbara, California, États-Unis, 93105
        • Recrutement
        • Sansum Diabetes Research Institute
        • Contact:
        • Chercheur principal:
          • Andrew Rhinehart
      • Walnut Creek, California, États-Unis, 94598
        • Recrutement
        • Diablo Clinical Research, Inc.
        • Chercheur principal:
          • Mark Christiansen
        • Contact:
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06511
        • Pas encore de recrutement
        • Yale University School of Medicine
        • Contact:
        • Chercheur principal:
          • Laura Nally
    • Florida
      • Gainesville, Florida, États-Unis, 32610
        • Pas encore de recrutement
        • University of Florida
        • Contact:
        • Chercheur principal:
          • Michael Haller
      • Tampa, Florida, États-Unis, 33612
        • Pas encore de recrutement
        • University of South Florida (USF) Diabetes and Endocrinology Center
        • Contact:
          • Elizabeth Doble
          • Numéro de téléphone: 813-974-5529
          • E-mail: edoble@usf.edu
        • Chercheur principal:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, États-Unis, 30318
    • Idaho
      • Idaho Falls, Idaho, États-Unis, 83404
    • Texas
      • Austin, Texas, États-Unis, 78749
        • Recrutement
        • Texas Diabetes and Endocrinology
        • Contact:
        • Chercheur principal:
          • Lindsay Harrison
      • San Antonio, Texas, États-Unis, 78240
        • Recrutement
        • Diabetes and Glandular Disease Clinic
        • Chercheur principal:
          • Mark Kipnes
        • Contact:
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22903
        • Recrutement
        • University of Virginia Health System
        • Contact:
        • Chercheur principal:
          • Mark DeBoer
    • Washington
      • Renton, Washington, États-Unis, 98057
        • Recrutement
        • Rainier Clinical Research Center
        • Chercheur principal:
          • Sheryl Marks
        • Contact:
      • Seattle, Washington, États-Unis, 98105
        • Pas encore de recrutement
        • Seattle Children's
        • Contact:
        • Chercheur principal:
          • Catherine Pihoker

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

2 ans à 80 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Age 2-80 years at time of screening.

  2. Has a clinical diagnosis of diabetes as stipulated according to the following age group:

    1. Age 2-10 years: Has a clinical diagnosis of T1D or T2D as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
    2. Age 11-80 years: Has a clinical diagnosis of T1D or T2D for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.

  3. Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.

  4. Is willing to provide informed consent/assent for participation.

  5. If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff.

  6. Is willing to perform fingerstick blood glucose measurements as needed.

  7. Is willing to wear the study devices continuously throughout the study.

  8. Subject or parent(s)/guardian(s)/caregiver(s) is/are willing to complete the requirements for diary data entry, as applicable.

  9. If participating in glycemic challenges, has met the following conditions:

    1. Been using insulin for at least 3 months
    2. A relatively stable insulin-to-carbohydrate ratio(s) and insulin sensitivity factor(s) for at least one month per investigator assessment Subjects who do not meet the above conditions can be included in the study, however, will participate in the FST under observation only (no glycemic challenges).

Exclusion Criteria:

  1. Unable to consent due to a mental or intellectual disability.

  2. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.

  3. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.

  4. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.

  5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.

  6. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.

  7. Has a history of a seizure disorder.

  8. Has a central nervous system or cardiac disorder resulting in syncope.

  9. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

  10. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

  11. Currently pregnant or planning to become pregnant during the time period of study participation

    1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening
    2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable

  12. Has diagnosis of adrenal insufficiency.

  13. Is using hydroxyurea at time of screening or plans to use it during the study.

  14. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study. (Please note participation in an observational study is acceptable.)

  15. Has a planned procedure involving the use of a Magnetic Resonance Imaging (MRI), diathermy devices, or other devices that generate strong magnetic fields (e.g., x-ray, CT scan, or other types of radiation) during the study wear period.

  16. Has elective surgery planned that requires general anesthesia during the course of the study.

  17. T2D: Is using insulin secretagogue.

  18. Is, at the discretion of the investigator, abusing drugs or alcohol

  19. Age 7-80 years: has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that prior blood draw from routine care may be used as long as the prior blood draw was done within 3 months prior to screening and report of lab placed with subject source documents).

  20. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

  21. Has had any of the following cardiovascular events more than 1 year prior to screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. However, subject may participate at the discretion of the investigator and with clearance from the cardiologist.

  22. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

  23. Is a member of the research staff involved with the study.

  24. Is a sponsor employee or their immediate family member (excluding adult children and/or adult siblings).

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: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Next Generation Extended Wear Sensors

All subjects will wear the sensor. Each subject and subject's parent/guardian/caregiver (if applicable) may insert and tape (if applicable) the study glucose sensors once trained or have them inserted and taped (if applicable) by the trained investigational center staff.
Dispositif: Next Generation Extended Wear Sensors

Disposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary Safety Endpoints
Délai: Approximately up to 46 days

Descriptive summary will be used to characterize:

  • Skin assessment of subject's glucose sensor insertion sites

  • Adverse events (AE) to include:

    • Serious Adverse Events (SAE)
    • Device Related AEs
    • Procedure Related AEs
    • Serious Adverse Device Effects (SADE)
    • Unanticipated Adverse Device Effects (UADE)
    • Severe hypoglycemia
    • Diabetic Ketoacidosis (DKA)
    • Hyperosmolar Hyperglycemic State (HHS)
Approximately up to 46 days

Collaborateurs et enquêteurs

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

Parrainer

Medtronic MiniMed, Inc.

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)

5 octobre 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

28 septembre 2026

Première soumission répondant aux critères de contrôle qualité

2 octobre 2026

Première publication (Réel)

7 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CIP358

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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