NCT06865989View on ClinicalTrials.gov

Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

NAActive, not recruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

March 26, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Diabetes Mellitus, Type 1, Type 2
Interventions
DEVICE

Omnipod 5 SmartAdjust 2.0 System

Omnipod 5 System with changes

DEVICE

Omnipod 5 System

Cleared device as comparator

Trial Locations (11)

44106

University Hospitals Cleveland, Cleveland

48202

Henry Ford, Detroit

55416

International Diabetes Center, Minneapolis

60611

Northwestern University, Chicago

77030

Baylor College of Medicine, Houston

78229

Diabetes and Glandular Disease Clinic, San Antonio

80045

University of Colorado Denver, Aurora

90022

University of Southern California, Los Angeles

93105

Sansum Diabetes Research Institute, Santa Barbara

06511

Yale University School of Medicine, New Haven

02215

Joslin Diabetes Center, Boston

Sponsors
All Listed Sponsors
lead

Insulet Corporation

INDUSTRY

NCT06865989 - Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes | Biotech Hunter | Biotech Hunter