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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 aggiornato da: Medtronic MiniMed, Inc.

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

1500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 80 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Next Generation Extended Wear Sensors

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Primary Safety Endpoints
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medtronic MiniMed, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 ottobre 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

28 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 ottobre 2026

Primo Inserito (Effettivo)

7 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIP358

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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