This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.
This outpatient study consists of 2 phases. Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information. Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
343
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
University of Southern California
Los Angeles, California, United States
Change in HbA1c
The change in HbA1c at 13 weeks from baseline
Time frame: Comparing the change in HbA1c during the 13 weeks study phase
Mean Glucose
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: Measuring mean glucose during the 13 weeks study phase
Percentage of Time in Range 70-180 mg/dL
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percent of Time in Range 70-140 mg/dL
Glucose metric from study CGM
Time frame: Measured during 13 weeks study phase
Percent of Time ≥ 300 mg/dL
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percent of Time > 250 mg/dL
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percent of Time >180 mg/dL
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%]
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%]
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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West Palm Beach, Florida, United States
Emory
Atlanta, Georgia, United States
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Canton, Georgia, United States
Endocrine Research
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Joslin Diabetes
Boston, Massachusetts, United States
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Detroit, Michigan, United States
...and 11 more locations
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Change From Baseline in T2-DDAS 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.
Time frame: Baseline compared to end of week 13 visit
Percentage Meeting MCID for T2-DDAS
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.
Time frame: Baseline compared to end week 13 visit
Change From Baseline in Pittsburgh Sleep Quality Index Total Score
Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality).
Time frame: Baseline compared to end of week 13 visit
% Meeting MCID for Pittsburgh Sleep Quality Index
Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.
Time frame: Baseline compared to end of week 13 visit
Change From Baseline in HCS Total Score
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 week 13 visit
% Meeting MCID for HCS
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 week 13 visit
Percentage of Time <70 mg/dL (Superiority)
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Percentage of Time <54 mg/dL (Superiority)
Glucose metric from CGM
Time frame: Measured during 13 weeks study phase
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Time frame: Measured during 13 weeks study phase and compared to standard therapy