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

12. november 2026 oppdatert av: Medtronic MiniMed, Inc.

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

1500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Chula Vista, California, Forente stater, 91911
      • Escondido, California, Forente stater, 92025-6428
      • Palo Alto, California, Forente stater, 94304
        • Har ikke rekruttert ennå
        • Stanford University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rayhan Lal
      • San Diego, California, Forente stater, 92123
        • Har ikke rekruttert ennå
        • Rady Children's Hospital - San Diego
        • Ta kontakt med:
        • Hovedetterforsker:
          • Anna Cymbaluk
      • San Francisco, California, Forente stater, 94158
        • Har ikke rekruttert ennå
        • University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laya Ekhlaspour
      • Santa Barbara, California, Forente stater, 93105
        • Rekruttering
        • Sansum Diabetes Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrew Rhinehart
      • Walnut Creek, California, Forente stater, 94598
        • Rekruttering
        • Diablo Clinical Research, Inc.
        • Hovedetterforsker:
          • Mark Christiansen
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
        • Har ikke rekruttert ennå
        • Yale University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laura Nally
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • Har ikke rekruttert ennå
        • University of Florida
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Haller
      • Tampa, Florida, Forente stater, 33612
        • Har ikke rekruttert ennå
        • University of South Florida (USF) Diabetes and Endocrinology Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
    • Texas
      • Austin, Texas, Forente stater, 78749
        • Rekruttering
        • Texas Diabetes and Endocrinology
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lindsay Harrison
      • San Antonio, Texas, Forente stater, 78240
        • Rekruttering
        • Diabetes and Glandular Disease Clinic
        • Hovedetterforsker:
          • Mark Kipnes
        • Ta kontakt med:
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22903
        • Rekruttering
        • University of Virginia Health System
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mark DeBoer
    • Washington
      • Renton, Washington, Forente stater, 98057
        • Rekruttering
        • Rainier Clinical Research Center
        • Hovedetterforsker:
          • Sheryl Marks
        • Ta kontakt med:
      • Seattle, Washington, Forente stater, 98105
        • Har ikke rekruttert ennå
        • Seattle Children's
        • Ta kontakt med:
        • Hovedetterforsker:
          • Catherine Pihoker

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år til 80 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Next Generation Extended Wear Sensors

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Safety Endpoints
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medtronic MiniMed, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. oktober 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

28. september 2026

Først innsendt som oppfylte QC-kriteriene

2. oktober 2026

Først lagt ut (Faktiske)

7. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIP358

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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