Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

Part of paid clinical trials in Los Angeles, California.

Sponsor
Insulet Corporation
Study ID
NCT07579702
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omnipod 5 System — DEVICE
    The Omnipod 5 System with the study CGM
  • Omnipod 6 System — DEVICE
    The Omnipod 6 System with the study CGM

Study Details

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.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omnipod 5 System
  • Experimental: Omnipod 6 System

Primary Outcome Measure

Time in Range 70-180 mg/dL [ Time Frame: 13 weeks ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90022
Martha Walker
[email protected]
323-605-4442
Anne Peters (PRINCIPAL_INVESTIGATOR)
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105
Juliana Lopez
[email protected]
8057059465
Kristin Castorino (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Estella Escobar
[email protected]
(720) 305-7817
Gregory Forlenza (PRINCIPAL_INVESTIGATOR)
YaleNew HavenConnecticut06511
Amy Steffen
[email protected]
203-737-8852
Amy Steffen (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33612
Janet Rodriguez
[email protected]
813-821-8011
Dorothy Shulman (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30308
Sabeena Usman
Georgia Davis (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Evelyn Fronczyk
[email protected]
312-908-9002
Grazia Aleppo (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Kathy Bohanan
[email protected]
317-278-0651
Viral Shah (PRINCIPAL_INVESTIGATOR)
Joslin Diabetes CenterBostonMassachusetts02215
Louise Ambler-Osborn
[email protected]
617-975-8206
Lori Laffel (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemsDetroitMichigan48202
Lydia Oehring
[email protected]
+1 (313) 916-3906
Davida Kruger (PRINCIPAL_INVESTIGATOR)
Health PartnersMinneapolisMinnesota55416
Stephanie Zimmerman
[email protected]
952-993-2048
Amy Criego (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Anh Nguyen
[email protected]
(832) 822-3870
Daniel DeSalvo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Type 1 diabetesType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Southern California· Los Angeles, CASansum Diabetes Research Institute· Santa Barbara, CAUniversity of Colorado· Aurora, COYale· New Haven, CTUniversity of South Florida· Tampa, FLEmory University· Atlanta, GA

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