Trial Outcomes & Findings for Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes (NCT NCT04617795)
NCT ID: NCT04617795
Last Updated: 2025-04-18
Results Overview
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
8-10 weeks and after 6-month optional extension
Results posted on
2025-04-18
Participant Flow
Participant milestones
| Measure |
Basal-Bolus (Group A)
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
Basal (Group B)
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
|---|---|---|
|
Main Study
STARTED
|
13
|
12
|
|
Main Study
COMPLETED
|
12
|
12
|
|
Main Study
NOT COMPLETED
|
1
|
0
|
|
Optional 6-month Extension
STARTED
|
12
|
12
|
|
Optional 6-month Extension
COMPLETED
|
12
|
10
|
|
Optional 6-month Extension
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Basal-Bolus (Group A)
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
Basal (Group B)
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
|---|---|---|
|
Main Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
35.19 kg/m^2
STANDARD_DEVIATION 4.53 • n=5 Participants
|
31.88 kg/m^2
STANDARD_DEVIATION 3.84 • n=7 Participants
|
33.54 kg/m^2
STANDARD_DEVIATION 4.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8-10 weeks and after 6-month optional extensionPopulation: In Group B, only 10 subjects completed the extension study.
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Hyperglycemia
Overall ST
|
33.3 Percent of Time (%)
Standard Deviation 23.8
|
21.5 Percent of Time (%)
Standard Deviation 16.8
|
|
Hyperglycemia
Overall AUTO
|
11.7 Percent of Time (%)
Standard Deviation 11.3
|
9.3 Percent of Time (%)
Standard Deviation 5.6
|
|
Hyperglycemia
Overall Extension
|
6.4 Percent of Time (%)
Standard Deviation 4.8
|
12.4 Percent of Time (%)
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: 8-10 weeks and after 6-month optional extensionPopulation: In Group B, only 10 subjects completed the extension study.
Overall percentage of time \<54 mg/dL during standard therapy phase and all phases of Automated Mode
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Hypoglycemia
Overall ST
|
0.02 Percent of Time (%)
Standard Deviation 0.07
|
0.19 Percent of Time (%)
Standard Deviation 0.36
|
|
Hypoglycemia
Overall AUTO
|
0.01 Percent of Time (%)
Standard Deviation 0.02
|
0.05 Percent of Time (%)
Standard Deviation 0.09
|
|
Hypoglycemia
Overall Extension
|
0.04 Percent of Time (%)
Standard Deviation 0.05
|
0.02 Percent of Time (%)
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Percent of Time in Range 70-180 mg/dL
Overall ST
|
30.5 Percent of Time (%)
Standard Deviation 17.4
|
42.8 Percent of Time (%)
Standard Deviation 20.4
|
|
Percent of Time in Range 70-180 mg/dL
Overall AUTO
|
56.6 Percent of Time (%)
Standard Deviation 17.7
|
60.5 Percent of Time (%)
Standard Deviation 14.3
|
|
Percent of Time in Range 70-180 mg/dL
Overall Extension
|
65.3 Percent of Time (%)
Standard Deviation 15.2
|
58.1 Percent of Time (%)
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Percent of Time > 180 mg/dL
Overall ST
|
69.2 Percent of Time (%)
Standard Deviation 17.6
|
56.3 Percent of Time (%)
Standard Deviation 20.6
|
|
Percent of Time > 180 mg/dL
Overall AUTO
|
43.3 Percent of Time (%)
Standard Deviation 17.7
|
39.3 Percent of Time (%)
Standard Deviation 14.3
|
|
Percent of Time > 180 mg/dL
Overall Extension
|
34.5 Percent of Time (%)
Standard Deviation 15.1
|
41.8 Percent of Time (%)
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Percent of Time ≥ 300 mg/dL
Overall ST
|
16.0 Percent of Time (%)
Standard Deviation 17.3
|
8.8 Percent of Time (%)
Standard Deviation 9.1
|
|
Percent of Time ≥ 300 mg/dL
Overall AUTO
|
4.3 Percent of Time (%)
Standard Deviation 5.9
|
2.2 Percent of Time (%)
Standard Deviation 1.8
|
|
Percent of Time ≥ 300 mg/dL
Overall Exension
|
1.5 Percent of Time (%)
Standard Deviation 1.4
|
4.5 Percent of Time (%)
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Percent of Time < 70 mg/dL
Overall ST
|
0.26 Percent of Time (%)
Standard Deviation 0.56
|
0.91 Percent of Time (%)
Standard Deviation 1.54
|
|
Percent of Time < 70 mg/dL
Overall AUTO
|
0.08 Percent of Time (%)
Standard Deviation 0.13
|
0.15 Percent of Time (%)
Standard Deviation 0.13
|
|
Percent of Time < 70 mg/dL
Overall Extension
|
0.15 Percent of Time (%)
Standard Deviation 0.22
|
0.11 Percent of Time (%)
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Standard Deviation
Overall ST
|
61.2 mg/dL
Standard Deviation 16.2
|
58.3 mg/dL
Standard Deviation 17.9
|
|
Standard Deviation
Overall AUTO
|
49.6 mg/dL
Standard Deviation 14.1
|
48.0 mg/dL
Standard Deviation 8.5
|
|
Standard Deviation
Overall Extension
|
43.6 mg/dL
Standard Deviation 9.2
|
52.7 mg/dL
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 subjects completed the extension.
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.
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Coefficient of Variation (of Glucose)
Overall ST
|
27.6 Percent coefficient of variation
Standard Deviation 6.5
|
29.2 Percent coefficient of variation
Standard Deviation 6.8
|
|
Coefficient of Variation (of Glucose)
Overall AUTO
|
27.0 Percent coefficient of variation
Standard Deviation 5.1
|
27.3 Percent coefficient of variation
Standard Deviation 3.8
|
|
Coefficient of Variation (of Glucose)
Overall Extension
|
25.6 Percent coefficient of variation
Standard Deviation 4.5
|
29.0 Percent coefficient of variation
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Mean Glucose
Overall ST
|
224.6 mg/dL
Standard Deviation 40.9
|
199.1 mg/dL
Standard Deviation 32.5
|
|
Mean Glucose
Overall AUTO
|
181.9 mg/dL
Standard Deviation 25.0
|
175.5 mg/dL
Standard Deviation 16.9
|
|
Mean Glucose
Overall Extension
|
169.6 mg/dL
Standard Deviation 16.8
|
180.7 mg/dL
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 participants completed the extension.
Measure of insulin requirements
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Total Daily Insulin (Units)
ST
|
30.6 units
Standard Deviation 21.9
|
92.4 units
Standard Deviation 44.0
|
|
Total Daily Insulin (Units)
AUTO
|
42.1 units
Standard Deviation 38.4
|
63.1 units
Standard Deviation 26.4
|
|
Total Daily Insulin (Units)
Extension
|
38.7 units
Standard Deviation 33.3
|
68.7 units
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: 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 BPopulation: In Group B, only 10 subjects completed the extension.
Measure of insulin requirements
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Total Daily Insulin (Units/kg)
ST
|
0.33 units/kg
Standard Deviation 0.20
|
0.89 units/kg
Standard Deviation 0.32
|
|
Total Daily Insulin (Units/kg)
AUTO
|
0.45 units/kg
Standard Deviation 0.40
|
0.62 units/kg
Standard Deviation 0.23
|
|
Total Daily Insulin (Units/kg)
Extension
|
0.40 units/kg
Standard Deviation 0.31
|
0.68 units/kg
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 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 -30Population: In Group B, only 10 participants completed the extension.
Measures average blood sugar levels over the past 3 months
Outcome measures
| Measure |
Basal (Group B)
n=12 Participants
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A)
n=12 Participants
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 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.
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c)
Baseline
|
9.5 Percentage of HbA1C
Standard Deviation 0.8
|
9.4 Percentage of HbA1C
Standard Deviation 1.0
|
|
Change in Hemoglobin A1c (HbA1c)
End of Main Study
|
8.1 Percentage of HbA1C
Standard Deviation 0.6
|
8.1 Percentage of HbA1C
Standard Deviation 0.8
|
|
Change in Hemoglobin A1c (HbA1c)
End of Extension
|
7.5 Percentage of HbA1C
Standard Deviation 0.6
|
8.0 Percentage of HbA1C
Standard Deviation 0.7
|
Adverse Events
Basal-Bolus (Group A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Basal (Group B)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Basal-Bolus (Group A Extension)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Basal (Group B Extension)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Basal-Bolus (Group A)
n=12 participants at risk
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
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.
|
Basal (Group B)
n=12 participants at risk
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A Extension)
n=12 participants at risk
• 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.
|
Basal (Group B Extension)
n=10 participants at risk
• 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.
|
|---|---|---|---|---|
|
Investigations
Other
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Basal-Bolus (Group A)
n=12 participants at risk
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
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.
|
Basal (Group B)
n=12 participants at risk
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 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.
|
Basal-Bolus (Group A Extension)
n=12 participants at risk
• 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.
|
Basal (Group B Extension)
n=10 participants at risk
• 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.
|
|---|---|---|---|---|
|
Endocrine disorders
Prolonged Hyperglycemia
|
8.3%
1/12 • Number of events 2 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
33.3%
4/12 • Number of events 9 • 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.
|
0.00%
0/10 • 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.
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Investigations
Other
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
20.0%
2/10 • Number of events 3 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place