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Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
The study schedule consists of two outpatient phases:
Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study.
Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator.
After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Experimental | All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Device | Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Pinsker, MD | Sansum Diabetes Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| University of Colorado Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34491825 | Derived | Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O'Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment. Diabetes Technol Ther. 2022 Jan;24(1):18-25. doi: 10.1089/dia.2021.0140. Epub 2021 Sep 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omnipod Horizon™ Automated Glucose Control System | All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Omnipod Horizon™ Without CGM |
| |||||||||||||
| Phase 2: Omnipod Horizon™ With CGM |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omnipod Horizon™ Automated Glucose Control System | All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
First day of Phase 1 to last day of Phase 2, an average of 14 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single | All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Trang Ly | Insulet Corporation | 9786007628 | tly@insulet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Oct 18, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a single-arm, multi-center, prospective clinical study.
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| Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Percentage of Time in Range 70-140 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Standard Deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
| Denver |
| Colorado |
| 80045 |
| United States |
| Atlanta Diabetes | Atlanta | Georgia | 30318 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
|
|
|
| Secondary | Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | mg/dL | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Percentage of Time in Range 70-140 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Posted | Mean | Standard Deviation | Percent Time in Range | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Standard Deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | Posted | Mean | Standard Deviation | mg/dL | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| Secondary | Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | Posted | Mean | Standard Deviation | Percent coefficient of variation | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 0 |
| 25 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
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| Title | Measurements |
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