Trial Outcomes & Findings for Prepivotal Omnipod Horizon™ Automated Glucose Control System (NCT NCT04176731)
NCT ID: NCT04176731
Last Updated: 2023-11-13
Results Overview
Measure of serious device-related adverse events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
hybrid closed-loop (14 days)
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Treatment
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prepivotal Omnipod Horizon™ Automated Glucose Control System
Baseline characteristics by cohort
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI
|
22.6 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: hybrid closed-loop (14 days)Measure of serious device-related adverse events
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Proportion of Subjects With Severe Hypoglycemia
|
0 Participants
|
PRIMARY outcome
Timeframe: hybrid closed-loop (14 days)Measure of serious device-related adverse events
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Proportion of Subjects With Diabetic Ketoacidosis (DKA)
|
0 Participants
|
PRIMARY outcome
Timeframe: hybrid closed-loop (9 days) compared to standard therapy (14 days)Percentage of time in range 70-180 mg/dL
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Day Time ST
|
58 Overall Percent Time in Range
Standard Deviation 17.1
|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Day Time HCL
|
62.2 Overall Percent Time in Range
Standard Deviation 9.6
|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Night Time ST
|
59.2 Overall Percent Time in Range
Standard Deviation 16.4
|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Night Time HCL
|
71.2 Overall Percent Time in Range
Standard Deviation 14.0
|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Overall ST
|
58.3 Overall Percent Time in Range
Standard Deviation 16.2
|
|
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Overall HCL
|
64.4 Overall Percent Time in Range
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: hybrid closed-loop (5 days) compared to standard therapy (14 days)Percentage of time in range 70-180 mg/dL
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Day Time ST
|
58.0 Overall Percent Time in Range
Standard Deviation 17.1
|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Day Time HCL
|
67.2 Overall Percent Time in Range
Standard Deviation 11.9
|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Night Time ST
|
59.2 Overall Percent Time in Range
Standard Deviation 16.4
|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Night Time HCL
|
72.8 Overall Percent Time in Range
Standard Deviation 18.2
|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Overall ST
|
58.3 Overall Percent Time in Range
Standard Deviation 16.2
|
|
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Overall HCL
|
68.7 Overall Percent Time in Range
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: hybrid closed-loop (14 days) compared to standard therapy (14 days)Percentage of time in range 70-180 mg/dL
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Day Time ST
|
58.0 Overall Percent Time in Range
Standard Deviation 17.1
|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Day Time HCL
|
63.9 Overall Percent Time in Range
Standard Deviation 8.3
|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Night Time ST
|
59.2 Overall Percent Time in Range
Standard Deviation 16.4
|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Night Time HCL
|
71.1 Overall Percent Time in Range
Standard Deviation 13.3
|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Overall ST
|
58.3 Overall Percent Time in Range
Standard Deviation 16.2
|
|
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Overall HCL
|
65.8 Overall Percent Time in Range
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Mean Glucose
Day Time ST
|
172.8 mg/dL
Standard Deviation 29.8
|
|
Mean Glucose
Day Time HCL
|
168.4 mg/dL
Standard Deviation 12.7
|
|
Mean Glucose
Night Time ST
|
165.8 mg/dL
Standard Deviation 28.4
|
|
Mean Glucose
Night Time HCL
|
163.0 mg/dL
Standard Deviation 16.2
|
|
Mean Glucose
Overall ST
|
171.2 mg/dL
Standard Deviation 27.7
|
|
Mean Glucose
Overall HCL
|
167.0 mg/dL
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Time in Range 70-180 mg/dL
Day Time ST
|
58.0 Percent Time in Range
Standard Deviation 17.1
|
|
Time in Range 70-180 mg/dL
Day Time HCL
|
63.9 Percent Time in Range
Standard Deviation 8.3
|
|
Time in Range 70-180 mg/dL
Night Time ST
|
59.2 Percent Time in Range
Standard Deviation 16.4
|
|
Time in Range 70-180 mg/dL
Night Time HCL
|
71.1 Percent Time in Range
Standard Deviation 13.3
|
|
Time in Range 70-180 mg/dL
Overall ST
|
58.3 Percent Time in Range
Standard Deviation 16.2
|
|
Time in Range 70-180 mg/dL
Overall HCL
|
65.8 Percent Time in Range
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Time in Range 70-140 mg/dL
Day Time ST
|
35.7 Percent Time in Range
Standard Deviation 15.6
|
|
Time in Range 70-140 mg/dL
Day Time HCL
|
33.2 Percent Time in Range
Standard Deviation 6.7
|
|
Time in Range 70-140 mg/dL
Night Time ST
|
37.8 Percent Time in Range
Standard Deviation 16.7
|
|
Time in Range 70-140 mg/dL
Night Time HCL
|
35.3 Percent Time in Range
Standard Deviation 12.8
|
|
Time in Range 70-140 mg/dL
Overall ST
|
36.2 Percent Time in Range
Standard Deviation 15.2
|
|
Time in Range 70-140 mg/dL
Overall HCL
|
33.8 Percent Time in Range
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time >180 mg/dL
Day Time ST
|
39.5 Percent Time in Range
Standard Deviation 18.4
|
|
Percentage of Time >180 mg/dL
Day Time HCL
|
35.1 Percent Time in Range
Standard Deviation 8.5
|
|
Percentage of Time >180 mg/dL
Night Time ST
|
36.6 Percent Time in Range
Standard Deviation 17.7
|
|
Percentage of Time >180 mg/dL
Night Time HCL
|
27.8 Percent Time in Range
Standard Deviation 13.4
|
|
Percentage of Time >180 mg/dL
Overall ST
|
38.8 Percent Time in Range
Standard Deviation 17.2
|
|
Percentage of Time >180 mg/dL
Overall HCL
|
33.3 Percent Time in Range
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time ≥250 mg/dL
Day Time ST
|
14.6 Percent Time in Range
Standard Deviation 10.7
|
|
Percentage of Time ≥250 mg/dL
Day Time HCL
|
9.1 Percent Time in Range
Standard Deviation 6.1
|
|
Percentage of Time ≥250 mg/dL
Night Time ST
|
12.6 Percent Time in Range
Standard Deviation 10.5
|
|
Percentage of Time ≥250 mg/dL
Night Time HCL
|
6.5 Percent Time in Range
Standard Deviation 6.6
|
|
Percentage of Time ≥250 mg/dL
Overall ST
|
14.1 Percent Time in Range
Standard Deviation 9.9
|
|
Percentage of Time ≥250 mg/dL
Overall HCL
|
8.5 Percent Time in Range
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time ≥300 mg/dL
Day Time ST
|
5.6 Percent Time in Range
Standard Deviation 5.9
|
|
Percentage of Time ≥300 mg/dL
Day Time HCL
|
2.4 Percent Time in Range
Standard Deviation 2.4
|
|
Percentage of Time ≥300 mg/dL
Night Time ST
|
4.6 Percent Time in Range
Standard Deviation 5.8
|
|
Percentage of Time ≥300 mg/dL
Night Time HCL
|
2.0 Percent Time in Range
Standard Deviation 3.2
|
|
Percentage of Time ≥300 mg/dL
Overall ST
|
5.4 Percent Time in Range
Standard Deviation 5.3
|
|
Percentage of Time ≥300 mg/dL
Overall HCL
|
2.3 Percent Time in Range
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time <70 mg/dL
Day Time ST
|
2.4 Percent Time in Range
Standard Deviation 2.6
|
|
Percentage of Time <70 mg/dL
Day Time HCL
|
1.0 Percent Time in Range
Standard Deviation 1.1
|
|
Percentage of Time <70 mg/dL
Night Time ST
|
4.2 Percent Time in Range
Standard Deviation 5.2
|
|
Percentage of Time <70 mg/dL
Night Time HCL
|
0.5 Percent Time in Range
Standard Deviation 1.3
|
|
Percentage of Time <70 mg/dL
Overall ST
|
2.9 Percent Time in Range
Standard Deviation 3.0
|
|
Percentage of Time <70 mg/dL
Overall HCL
|
0.9 Percent Time in Range
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time <54 mg/dL
Day Time ST
|
0.5 Percent Time in Range
Standard Deviation 0.7
|
|
Percentage of Time <54 mg/dL
Day Time HCL
|
0.1 Percent Time in Range
Standard Deviation 0.3
|
|
Percentage of Time <54 mg/dL
Night Time ST
|
1.1 Percent Time in Range
Standard Deviation 1.8
|
|
Percentage of Time <54 mg/dL
Night Time HCL
|
0.1 Percent Time in Range
Standard Deviation 0.4
|
|
Percentage of Time <54 mg/dL
Overall ST
|
0.6 Percent Time in Range
Standard Deviation 0.9
|
|
Percentage of Time <54 mg/dL
Overall HCL
|
0.1 Percent Time in Range
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Standard Deviation of Glucose (mg/dL)
Day Time ST
|
62.9 mg/dL
Standard Deviation 14.7
|
|
Standard Deviation of Glucose (mg/dL)
Day Time HCL
|
53.4 mg/dL
Standard Deviation 9.5
|
|
Standard Deviation of Glucose (mg/dL)
Night Time ST
|
60.5 mg/dL
Standard Deviation 17.8
|
|
Standard Deviation of Glucose (mg/dL)
Night Time HCL
|
45.0 mg/dL
Standard Deviation 14.2
|
|
Standard Deviation of Glucose (mg/dL)
Overall ST
|
63.3 mg/dL
Standard Deviation 14.9
|
|
Standard Deviation of Glucose (mg/dL)
Overall HCL
|
52.3 mg/dL
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Coefficient of Variation
Day Time ST
|
36.3 Percent
Standard Deviation 5.0
|
|
Coefficient of Variation
Day Time HCL
|
31.6 Percent
Standard Deviation 4.4
|
|
Coefficient of Variation
Night Time ST
|
36.5 Percent
Standard Deviation 9.2
|
|
Coefficient of Variation
Night Time HCL
|
27.3 Percent
Standard Deviation 7.2
|
|
Coefficient of Variation
Overall ST
|
36.9 Percent
Standard Deviation 5.9
|
|
Coefficient of Variation
Overall HCL
|
31.2 Percent
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days)Measurement of glucose management using overall glucose averages
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Day Time ST
|
7.4 Percent
Standard Deviation 0.7
|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Day Time HCL
|
7.3 Percent
Standard Deviation 0.3
|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Night Time ST
|
7.3 Percent
Standard Deviation 0.7
|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Night Time HCL
|
7.2 Percent
Standard Deviation 0.4
|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Overall ST
|
7.4 Percent
Standard Deviation 0.7
|
|
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Overall HCL
|
7.3 Percent
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days)Measure of system usage
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Automated Mode
|
97.3 Percent Time Spent
Standard Deviation 3
|
|
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Manual Mode
|
2.1 Percent Time Spent
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Total Daily Insulin (TDI) (Units, Units/kg)
ST
|
39.5 units/kg
Standard Deviation 13.5
|
|
Total Daily Insulin (TDI) (Units, Units/kg)
HCL
|
37.0 units/kg
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Total Daily Basal Insulin (Units, Units/kg)
ST
|
20.7 units/kg
Standard Deviation 10.3
|
|
Total Daily Basal Insulin (Units, Units/kg)
HCL
|
17.5 units/kg
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: hybrid closed-loop (14 days) compared to the standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=36 Participants
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Total Daily Bolus Insulin (Units, Units/kg)
ST
|
19.4 units/kg
Standard Deviation 8.5
|
|
Total Daily Bolus Insulin (Units, Units/kg)
HCL
|
19.5 units/kg
Standard Deviation 7.8
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=36 participants at risk
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
2.8%
1/36 • First day of standard therapy to the last day in hybrid closed loop phase, average of 28 days.
|
|
Metabolism and nutrition disorders
Ketosis
|
2.8%
1/36 • First day of standard therapy to the last day in hybrid closed loop phase, average of 28 days.
|
|
Endocrine disorders
Prolonged Hyperglycemia
|
2.8%
1/36 • First day of standard therapy to the last day in hybrid closed loop phase, average of 28 days.
|
|
Musculoskeletal and connective tissue disorders
Shoulder problem
|
2.8%
1/36 • First day of standard therapy to the last day in hybrid closed loop phase, average of 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place