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The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Basal-Bolus - Group A (N=12)
Basal - Group B (N=12)
2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:
4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
6-month optional extension using Automated Mode
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal-Bolus (Group A) | Experimental |
|
|
| Basal (Group B) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod 5 Automated Insulin Delivery System | Device | The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperglycemia | Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode | 8-10 weeks and after 6-month optional extension |
| Hypoglycemia | Overall percentage of time <54 mg/dL during standard therapy phase and all phases of Automated Mode | 8-10 weeks and after 6-month optional extension |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Percent of Time > 180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Carlson, MD | International Diabetes Center at Park Nicollet | Study Chair |
| Anne Peters, MD | Keck School of Medicine of USC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90022 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382001 | Derived | Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT. Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Obes Metab. 2025 Jan;27(1):143-154. doi: 10.1111/dom.15993. Epub 2024 Oct 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal-Bolus (Group A) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| FG001 | Basal (Group B) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
|
| ||||||||||||||||||
| Optional 6-month Extension |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal-Bolus (Group A) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| 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 | Hyperglycemia | Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode | In Group B, only 10 subjects completed the extension study. | Posted | Mean | Standard Deviation | Percent of Time (%) | 8-10 weeks and after 6-month optional extension |
|
Start of standard therapy (-14d to +1d prior to OP5 start) until the end of the extension [251 days +/- 3 days].
Adverse events listed below were collected from the start of standard therapy until the end of the extension.
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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 | Basal-Bolus (Group A) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged Hyperglycemia | Endocrine disorders | 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 27, 2021 | Apr 15, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Glucose metric from study continuous glucose monitoring system |
| Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Percent of Time ≥ 300 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Percent of Time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Standard Deviation | Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Coefficient of Variation (of Glucose) | 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. | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Mean Glucose | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Total Daily Insulin (Units) | Measure of insulin requirements | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Total Daily Insulin (Units/kg) | Measure of insulin requirements | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
| Change in Hemoglobin A1c (HbA1c) | Measures average blood sugar levels over the past 3 months | End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30 |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Atlanta Diabetes | Atlanta | Georgia | 30318 | United States |
| International Diabetes Center | Saint Louis Park | Minnesota | 55416 | United States |
| NOT COMPLETED |
|
| BG001 | Basal (Group B) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| OG001 | Basal (Group B) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. |
|
|
| Primary | Hypoglycemia | Overall percentage of time <54 mg/dL during standard therapy phase and all phases of Automated Mode | In Group B, only 10 subjects completed the extension study. | Posted | Mean | Standard Deviation | Percent of Time (%) | 8-10 weeks and after 6-month optional extension |
|
|
|
| Secondary | Percent of Time in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | Percent of Time (%) | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Percent of Time > 180 mg/dL | Glucose metric from study continuous glucose monitoring system | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | Percent of Time (%) | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Percent of Time ≥ 300 mg/dL | Glucose metric from study continuous glucose monitoring system | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | Percent of Time (%) | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Percent of Time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | Percent of Time (%) | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Standard Deviation | Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | mg/dL | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Coefficient of Variation (of Glucose) | 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. | In Group B, only 10 subjects completed the extension. | Posted | Mean | Standard Deviation | Percent coefficient of variation | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Mean Glucose | Glucose metric from study continuous glucose monitoring system | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | mg/dL | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Total Daily Insulin (Units) | Measure of insulin requirements | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | units | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Total Daily Insulin (Units/kg) | Measure of insulin requirements | In Group B, only 10 subjects completed the extension. | Posted | Mean | Standard Deviation | units/kg | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B |
|
|
|
| Secondary | Change in Hemoglobin A1c (HbA1c) | Measures average blood sugar levels over the past 3 months | In Group B, only 10 participants completed the extension. | Posted | Mean | Standard Deviation | Percentage of HbA1C | End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Basal (Group B) |
Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. | 0 | 12 | 1 | 12 | 3 | 12 |
| EG002 | Basal-Bolus (Group A Extension) | • 6-month optional extension using Automated Mode Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. | 0 | 12 | 2 | 12 | 6 | 12 |
| EG003 | Basal (Group B Extension) | • 6-month optional extension using Automated Mode Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. | 0 | 10 | 1 | 10 | 2 | 10 |
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Other | Investigations | Systematic Assessment |
|
Not provided
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| D004700 | Endocrine System Diseases |
| Overall AUTO |
|
|
| Overall Extension |
|
|
| Overall AUTO |
|
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| Overall Extension |
|
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| Overall AUTO |
|
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| Overall Extension |
|
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| Overall AUTO |
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| Overall Exension |
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| Overall AUTO |
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| Overall Extension |
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| Overall AUTO |
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| Overall Extension |
|
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| Overall AUTO |
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| Overall Extension |
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| Overall AUTO |
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| Overall Extension |
|
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| AUTO |
|
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| Extension |
|
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| AUTO |
|
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| Extension |
|
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| End of Main Study |
|
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| End of Extension |
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