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Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System (STRIVE 2)

28 maggio 2026 aggiornato da: Insulet Corporation

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.

After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

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

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90022
        • Non ancora reclutamento
        • University of Southern California
        • Contatto:
        • Investigatore principale:
          • Anne Peters
      • Santa Barbara, California, Stati Uniti, 93105
        • Reclutamento
        • Sansum Diabetes Research Institute
        • Investigatore principale:
          • Kristin Castorino
        • Contatto:
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Non ancora reclutamento
        • University of Colorado
        • Investigatore principale:
          • Gregory Forlenza
        • Contatto:
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06511
        • Non ancora reclutamento
        • Yale
        • Contatto:
        • Investigatore principale:
          • Amy Steffen
    • Florida
      • Tampa, Florida, Stati Uniti, 33612
        • Non ancora reclutamento
        • University of South Florida
        • Contatto:
        • Investigatore principale:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Non ancora reclutamento
        • Emory University
        • Contatto:
          • Sabeena Usman
        • Investigatore principale:
          • Georgia Davis
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Non ancora reclutamento
        • Northwestern University
        • Investigatore principale:
          • Grazia Aleppo
        • Contatto:
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Non ancora reclutamento
        • Indiana University
        • Investigatore principale:
          • Viral Shah
        • Contatto:
          • Kathy Bohanan
          • Numero di telefono: 317-278-0651
          • Email: kkremer@iu.edu
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Reclutamento
        • Henry Ford Health Systems
        • Investigatore principale:
          • Davida Kruger
        • Contatto:
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Health Partners
        • Contatto:
        • Investigatore principale:
          • Amy Criego
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Non ancora reclutamento
        • Baylor College of Medicine
        • Contatto:
        • Investigatore principale:
          • Daniel DeSalvo

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

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age at time of consent 14-75 years (inclusive)
  • Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
  • Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
  • HbA1c ≥ 7.5%
  • Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
  • Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
  • Currently using a continuous glucose monitor
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
  • Participant agrees to provide their own insulin for the duration of the study
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Willing to wear the system continuously throughout the study
  • Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged < 18 years per local regulatory requirements
  • Able to read and understand English and operate the study device in English
  • If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

  • Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
  • Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
  • Any planned surgery during the study which could be considered major in the judgment of the investigator
  • History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  • Use of hydroxyurea
  • Plans to receive blood transfusion over the course of the study
  • Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
  • Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
  • Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
  • Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
  • Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
  • Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Omnipod 5 System
Dispositivo: Omnipod 5 System
The Omnipod 5 System with the study CGM
Sperimentale: Omnipod 6 System
Dispositivo: Omnipod 6 System
The Omnipod 6 System with the study CGM

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time in Range 70-180 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <54 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <70 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >180 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time in Range 70-140 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
HbA1c
Lasso di tempo: 13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
13 weeks
Mean sensor glucose
Lasso di tempo: 13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >250 mg/dL
Lasso di tempo: 13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total boluses per day
Lasso di tempo: 13 weeks
Total blues per day will be compared between Omnipod 6 and Omnipod 5
13 weeks
Total daily insulin per kg and total insulin delivered via automation
Lasso di tempo: 13 weeks
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage of time in automated mode
Lasso di tempo: 13 weeks
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with HbA1c <7.0% and <7.5%
Lasso di tempo: 13 weeks
Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 70% time in range
Lasso di tempo: 13 weeks
Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 50% time in range
Lasso di tempo: 13 weeks
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Diabetes treatment satisfaction
Lasso di tempo: 13 weeks
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
13 weeks
System Usability
Lasso di tempo: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
System Opinion
Lasso di tempo: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
Health Related Quality of Life (HR-QOL)
Lasso di tempo: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Hypoglycemia confidence
Lasso di tempo: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Missed Meal - Peak glucose
Lasso di tempo: 13 weeks
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - AUC
Lasso di tempo: 13 weeks
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Time in Range
Lasso di tempo: 13 weeks
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
Lasso di tempo: 13 weeks
Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
Lasso di tempo: 13 weeks
Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <54 mg/dL
Lasso di tempo: 13 weeks
Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <70 mg/dL
Lasso di tempo: 13 weeks
Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Number of severe hypoglycemic events
Lasso di tempo: 13 weeks
13 weeks
Number of DKA or HHS events
Lasso di tempo: 13 weeks
13 weeks
Other related serious adverse events
Lasso di tempo: 13 weeks
13 weeks
Unanticipated adverse device effects
Lasso di tempo: 13 weeks
13 weeks
Reportable device-related adverse events
Lasso di tempo: 13 weeks
13 weeks

Collaboratori e investigatori

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

Sponsor

Insulet Corporation

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)

13 maggio 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STRIVE 2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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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