Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.
This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth. Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system. Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system. Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
Stanford University School of Medicine
Palo Alto, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Percent of Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing intervention group with control group during the 13-week study phase
Percent of Time <54 mg/dL (Non-inferiority)
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Percent of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Mean Glucose
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Change in HbA1c
Measures device effectiveness
Time frame: Baseline compared to end of study visit (Day -30 to Day 90)
Percent of Time <70 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.
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University of Colorado Denver
Denver, Colorado, United States
Atlanta Diabetes
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
State University of New York, Upstate Medical University
Syracuse, New York, United States
Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
...and 4 more locations
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Hypoglycemic Confidence Scale (HCS) Total Score
A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Diabetes Quality of Life (DQOL)-Brief Total Score
A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome.
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Proportion of Participants With T1-DDS MCID After 13 Weeks
Proportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5
Time frame: Comparing intervention group with control group at the end of the 13-week study phase