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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The Omnipod 5 System with the study CGM
The Omnipod 6 System with the study CGM
University of Southern California
Los Angeles, California, United States
RECRUITINGSansum Diabetes Research Institute
Santa Barbara, California, United States
RECRUITINGTime in Range 70-180 mg/dL
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Time <54 mg/dL
Change in CGM percent time \<54 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Time <70 mg/dL
Change in CGM percent time \<70 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Time >180 mg/dL
Change in CGM percent time \>180 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Time in Range 70-140 mg/dL
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
HbA1c
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Mean sensor glucose
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Time >250 mg/dL
Change in CGM percent time \>250 mg/dL compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Total boluses per day
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University of Colorado
Aurora, Colorado, United States
RECRUITINGYale
New Haven, Connecticut, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGJoslin Diabetes Center
Boston, Massachusetts, United States
RECRUITINGHenry Ford Health Systems
Detroit, Michigan, United States
RECRUITINGHealth Partners
Minneapolis, Minnesota, United States
RECRUITING...and 1 more locations
Total blues per day will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Total daily insulin per kg and total insulin delivered via automation
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Percentage of time in automated mode
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Percentage with HbA1c <7.0% and <7.5%
Percentage with HbA1c \<7.0% and \<7.5% will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Percentage with >= 70% time in range
Percentage with \>= 70% time in range will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Percentage with >= 50% time in range
Percentage with \>= 50% time in range will be compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Diabetes treatment satisfaction
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
Time frame: 13 weeks
System Usability
Patient Reported Outcome Survey evaluated at the end of each 13-week period
Time frame: 13 weeks
System Opinion
Patient Reported Outcome Survey evaluated at the end of each 13-week period
Time frame: 13 weeks
Health Related Quality of Life (HR-QOL)
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
Time frame: 13 weeks
Hypoglycemia confidence
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
Time frame: 13 weeks
Missed Meal - Peak glucose
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - AUC
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - Time in Range
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
Percentage of Time \> 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
Percentage of Time \> 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - Percentage of Time <54 mg/dL
Percentage of Time \<54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Missed Meal - Percentage of Time <70 mg/dL
Percentage of Time \<70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Time frame: 13 weeks
Number of severe hypoglycemic events
Time frame: 13 weeks
Number of DKA or HHS events
Time frame: 13 weeks
Other related serious adverse events
Time frame: 13 weeks
Unanticipated adverse device effects
Time frame: 13 weeks
Reportable device-related adverse events
Time frame: 13 weeks