The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Omnipod 5 System with changes
Cleared device as comparator
University of Southern California
Los Angeles, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford
Detroit, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
...and 1 more locations
Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)
Glucose metric from continuous glucose monitoring system
Time frame: End of Period 2 (Day 56) compared to Baseline
Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)
Glucose metric from continuous glucose monitoring system
Time frame: End of Period 2 (Day 56) compared to Baseline
Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)
Glucose metric from continuous glucose monitoring system
Time frame: End of Period 2 (Day 56) compared to Baseline
Mean Glucose (non-inferiority margin of 8 mg/dL)
Glucose metric from continuous glucose monitoring system
Time frame: End of Period 2 (Day 56) compared to Baseline
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