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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod 5 System | Active Comparator |
| |
| Omnipod 6 System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod 5 System | Device | The Omnipod 5 System with the study CGM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range 70-180 mg/dL | Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Time <54 mg/dL | Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Time <70 mg/dL | Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Time >180 mg/dL | Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5 | 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 | 13 weeks |
| HbA1c | Change in HbA1c (%) between Omnipod 6 and Omnipod 5 | 13 weeks |
| Mean sensor glucose | Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Time >250 mg/dL | Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total boluses per day | Total blues per day will be compared between Omnipod 6 and Omnipod 5 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang Ly, MBBS, PhD | Contact | 978-600-7000 | APClinical@insulet.com | |
| Bonnie Dumais, RN | Contact | APClinical@insulet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90022 | United States |
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| Omnipod 6 System |
| Device |
The Omnipod 6 System with the study CGM |
|
| 13 weeks |
| Percentage of time in automated mode | Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5 | 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 | 13 weeks |
| Percentage with >= 70% time in range | Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Percentage with >= 50% time in range | Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Diabetes treatment satisfaction | Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6 | 13 weeks |
| System Usability | Patient Reported Outcome Survey evaluated at the end of each 13-week period | 13 weeks |
| System Opinion | Patient Reported Outcome Survey evaluated at the end of each 13-week period | 13 weeks |
| Health Related Quality of Life (HR-QOL) | Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6 | 13 weeks |
| Hypoglycemia confidence | Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6 | 13 weeks |
| Missed Meal - Peak glucose | Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Missed Meal - AUC | AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 | 13 weeks |
| Missed Meal - Time in Range | Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 | 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 | 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 | 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 | 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 | 13 weeks |
| Number of severe hypoglycemic events | 13 weeks |
| Number of DKA or HHS events | 13 weeks |
| Other related serious adverse events | 13 weeks |
| Unanticipated adverse device effects | 13 weeks |
| Reportable device-related adverse events | 13 weeks |
| Sansum Diabetes Research Institute | Recruiting | Santa Barbara | California | 93105 | United States |
|
| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Yale | Recruiting | New Haven | Connecticut | 06511 | United States |
|
| University of South Florida | Not yet recruiting | Tampa | Florida | 33612 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30308 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Henry Ford Health Systems | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Health Partners | Recruiting | Minneapolis | Minnesota | 55416 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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