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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod 5 SmartAdjust 2.0 System | Experimental | A subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system. |
|
| Omnipod 5 System | Active Comparator | A subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod 5 SmartAdjust 2.0 System | Device | Omnipod 5 System with changes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%) | Glucose metric from continuous glucose monitoring system | 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 | 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 | 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 | End of Period 2 (Day 56) compared to Baseline |
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Inclusion Criteria:
Age at time of consent 2-70 years (inclusive)
Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - < 7 years and at least 1 year for participants aged 7 - 70 years. OR 18-70 years old, diagnosed with type 2 diabetes for at least 1 year
Living with a parent or guardian if < 18 years old
Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit
Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
Participant agrees to provide their own insulin for the duration of the study
Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator
Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
Willing to wear the system continuously throughout the study
Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged < 18 years per state requirements
Able to read and understand English
If of childbearing potential, willing and able to have pregnancy testing
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Forlenza, MD | Barbara Davis Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90022 | United States | ||
| Sansum Diabetes Research Institute |
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Randomized two-sequence, multi-center crossover study
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| Omnipod 5 System | Device | Cleared device as comparator |
|
| Santa Barbara |
| California |
| 93105 |
| United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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