Trial Outcomes & Findings for Omnipod Horizon™ Automated Glucose Control System Preschool Cohort (NCT NCT04476472)
NCT ID: NCT04476472
Last Updated: 2024-02-14
Results Overview
Number of severe hypoglycemia events reported in "events per person months" units.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Results posted on
2024-02-14
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
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Baseline characteristics by cohort
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
BMI
|
16.7 kg/m^2
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Age, Continuous
|
4.7 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)Number of severe hypoglycemia events reported in "events per person months" units.
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Phase 2
|
0 events per person months
|
|
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Phase 3
|
0.0007 events per person months
|
PRIMARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)Number of DKA events reported in "events per person months" units.
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Phase 2
|
0 events per person months
|
|
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Phase 3
|
0.0007 events per person months
|
PRIMARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baselineMeasures device effectiveness
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Glycated Hemoglobin (A1C)
Baseline
|
7.4 percent A1C
Standard Deviation 1.0
|
|
Glycated Hemoglobin (A1C)
V13
|
6.9 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V16
|
7.0 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V19
|
7.1 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V21
|
6.9 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V23
|
7.0 percent A1C
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)Measures device effectiveness
Outcome measures
| Measure |
Treatment
n=80 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
Overall Phase 3
|
67.2 percent time in range
Standard Deviation 9.3
|
|
Time in Range 70-180 mg/dL
Day Time ST
|
56.9 percent time in range
Standard Deviation 15.2
|
|
Time in Range 70-180 mg/dL
Day Time Phase 2
|
63.7 percent time in range
Standard Deviation 9.7
|
|
Time in Range 70-180 mg/dL
Day Time Phase 3
|
63.5 percent time in range
Standard Deviation 9.8
|
|
Time in Range 70-180 mg/dL
Night Time ST
|
58.2 percent time in range
Standard Deviation 18.7
|
|
Time in Range 70-180 mg/dL
Night Time Phase 2
|
81.0 percent time in range
Standard Deviation 10.0
|
|
Time in Range 70-180 mg/dL
Night Time Phase 3
|
78.2 percent time in range
Standard Deviation 10.4
|
|
Time in Range 70-180 mg/dL
Overall ST
|
57.2 percent time in range
Standard Deviation 15.3
|
|
Time in Range 70-180 mg/dL
Overall Phase 2
|
68.1 percent time in range
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baselineMeasures device effectiveness
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Glycated Hemoglobin (A1C)
Baseline
|
7.4 percent A1C
Standard Deviation 1.0
|
|
Glycated Hemoglobin (A1C)
V13
|
6.9 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V16
|
7.0 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V19
|
7.1 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V21
|
6.9 percent A1C
Standard Deviation 0.7
|
|
Glycated Hemoglobin (A1C)
V23
|
7.0 percent A1C
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time in Range 70-140 mg/dL
Day Time ST
|
36.2 percent time in range
Standard Deviation 13.2
|
|
Percent of Time in Range 70-140 mg/dL
Day Time Phase 2
|
41.3 percent time in range
Standard Deviation 9.4
|
|
Percent of Time in Range 70-140 mg/dL
Day Time Phase 3
|
41.2 percent time in range
Standard Deviation 9.8
|
|
Percent of Time in Range 70-140 mg/dL
Night Time ST
|
36.7 percent time in range
Standard Deviation 16.9
|
|
Percent of Time in Range 70-140 mg/dL
Night Time Phase 2
|
57.7 percent time in range
Standard Deviation 13.7
|
|
Percent of Time in Range 70-140 mg/dL
Night Time Phase 3
|
53.9 percent time in range
Standard Deviation 13.1
|
|
Percent of Time in Range 70-140 mg/dL
Overall ST
|
36.3 percent time in range
Standard Deviation 13.4
|
|
Percent of Time in Range 70-140 mg/dL
Overall Phase 2
|
45.4 percent time in range
Standard Deviation 9.7
|
|
Percent of Time in Range 70-140 mg/dL
Overall Phase 3
|
44.4 percent time in range
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time > 180 mg/dL
Night Time ST
|
38.4 percent of time
Standard Deviation 20.1
|
|
Percent of Time > 180 mg/dL
Night Time Phase 2
|
16.9 percent of time
Standard Deviation 10.3
|
|
Percent of Time > 180 mg/dL
Night Time Phase 3
|
19.7 percent of time
Standard Deviation 10.6
|
|
Percent of Time > 180 mg/dL
Overall ST
|
39.4 percent of time
Standard Deviation 16.7
|
|
Percent of Time > 180 mg/dL
Overall Phase 2
|
29.5 percent of time
Standard Deviation 9.8
|
|
Percent of Time > 180 mg/dL
Overall Phase 3
|
30.2 percent of time
Standard Deviation 10.1
|
|
Percent of Time > 180 mg/dL
Day Time ST
|
39.7 percent of time
Standard Deviation 16.6
|
|
Percent of Time > 180 mg/dL
Day Time Phase 2
|
33.7 percent of time
Standard Deviation 10.7
|
|
Percent of Time > 180 mg/dL
Day Time Phase 3
|
33.7 percent of time
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time ≥ 250 mg/dL
Day Time ST
|
15.4 percent of time
Standard Deviation 12.7
|
|
Percent of Time ≥ 250 mg/dL
Day Time Phase 2
|
11.0 percent of time
Standard Deviation 6.6
|
|
Percent of Time ≥ 250 mg/dL
Day Time Phase 3
|
11.5 percent of time
Standard Deviation 6.9
|
|
Percent of Time ≥ 250 mg/dL
Night Time ST
|
13.0 percent of time
Standard Deviation 13.2
|
|
Percent of Time ≥ 250 mg/dL
Night Time Phase 2
|
3.9 percent of time
Standard Deviation 3.9
|
|
Percent of Time ≥ 250 mg/dL
Night Time Phase 3
|
5.1 percent of time
Standard Deviation 4.6
|
|
Percent of Time ≥ 250 mg/dL
Overall ST
|
14.8 percent of time
Standard Deviation 12.1
|
|
Percent of Time ≥ 250 mg/dL
Overall Phase 2
|
9.2 percent of time
Standard Deviation 5.6
|
|
Percent of Time ≥ 250 mg/dL
Overall Phase 3
|
9.9 percent of time
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time ≥ 300 mg/dL
Day Time ST
|
6.5 percent of time
Standard Deviation 8.0
|
|
Percent of Time ≥ 300 mg/dL
Day Time Phase 2
|
3.9 percent of time
Standard Deviation 3.4
|
|
Percent of Time ≥ 300 mg/dL
Day Time Phase 3
|
4.4 percent of time
Standard Deviation 3.8
|
|
Percent of Time ≥ 300 mg/dL
Night Time ST
|
4.3 percent of time
Standard Deviation 6.7
|
|
Percent of Time ≥ 300 mg/dL
Night Time Phase 2
|
1.2 percent of time
Standard Deviation 1.6
|
|
Percent of Time ≥ 300 mg/dL
Night Time Phase 3
|
1.8 percent of time
Standard Deviation 2.1
|
|
Percent of Time ≥ 300 mg/dL
Overall ST
|
6.0 percent of time
Standard Deviation 7.3
|
|
Percent of Time ≥ 300 mg/dL
Overall Phase 2
|
3.2 percent of time
Standard Deviation 2.8
|
|
Percent of Time ≥ 300 mg/dL
Overall Phase 3
|
3.7 percent of time
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time < 70 mg/dL
Day Time ST
|
3.44 percent of time
Standard Deviation 3.85
|
|
Percent of Time < 70 mg/dL
Day Time Phase 2
|
2.57 percent of time
Standard Deviation 1.99
|
|
Percent of Time < 70 mg/dL
Day Time Phase 3
|
2.79 percent of time
Standard Deviation 1.98
|
|
Percent of Time < 70 mg/dL
Night Time ST
|
3.41 percent of time
Standard Deviation 4.79
|
|
Percent of Time < 70 mg/dL
Overall ST
|
3.43 percent of time
Standard Deviation 3.87
|
|
Percent of Time < 70 mg/dL
Overall Phase 2
|
2.46 percent of time
Standard Deviation 1.83
|
|
Percent of Time < 70 mg/dL
Overall Phase 3
|
2.61 percent of time
Standard Deviation 1.82
|
|
Percent of Time < 70 mg/dL
Night Time Phase 2
|
2.13 percent of time
Standard Deviation 1.94
|
|
Percent of Time < 70 mg/dL
Night Time Phase 3
|
2.06 percent of time
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Percent of Time < 54 mg/dL
Day Time ST
|
0.80 percent of time
Standard Deviation 1.67
|
|
Percent of Time < 54 mg/dL
Day Time Phase 2
|
0.50 percent of time
Standard Deviation 0.61
|
|
Percent of Time < 54 mg/dL
Day Time Phase 3
|
0.59 percent of time
Standard Deviation 0.63
|
|
Percent of Time < 54 mg/dL
Night Time ST
|
0.85 percent of time
Standard Deviation 1.94
|
|
Percent of Time < 54 mg/dL
Night Time Phase 2
|
0.39 percent of time
Standard Deviation 0.53
|
|
Percent of Time < 54 mg/dL
Night Time Phase 3
|
0.49 percent of time
Standard Deviation 0.63
|
|
Percent of Time < 54 mg/dL
Overall ST
|
0.81 percent of time
Standard Deviation 1.68
|
|
Percent of Time < 54 mg/dL
Overall Phase 2
|
0.47 percent of time
Standard Deviation 0.54
|
|
Percent of Time < 54 mg/dL
Overall Phase 3
|
0.57 percent of time
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overallGlucose metric from study continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Treatment
n=80 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 Phase 2
|
163.0 mg/dL
Standard Deviation 18.3
|
|
Mean Glucose
Day Time Phase 3
|
163.6 mg/dL
Standard Deviation 19.3
|
|
Mean Glucose
Night Time ST
|
168.1 mg/dL
Standard Deviation 33.3
|
|
Mean Glucose
Night Time Phase 2
|
140.7 mg/dL
Standard Deviation 16.4
|
|
Mean Glucose
Night Time Phase 3
|
145.7 mg/dL
Standard Deviation 16.9
|
|
Mean Glucose
Overall ST
|
171.1 mg/dL
Standard Deviation 30.5
|
|
Mean Glucose
Overall Phase 2
|
157.4 mg/dL
Standard Deviation 16.8
|
|
Mean Glucose
Overall Phase 3
|
159.1 mg/dL
Standard Deviation 17.9
|
|
Mean Glucose
Day Time ST
|
172.2 mg/dL
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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=80 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
Day Time ST
|
66.1 mg/dL
Standard Deviation 13.7
|
|
Standard Deviation
Day Time Phase 2
|
62.2 mg/dL
Standard Deviation 10.5
|
|
Standard Deviation
Day Time Phase 3
|
63.4 mg/dL
Standard Deviation 11.3
|
|
Standard Deviation
Night Time ST
|
58.0 mg/dL
Standard Deviation 14.0
|
|
Standard Deviation
Overall Phase 2
|
59.6 mg/dL
Standard Deviation 10.3
|
|
Standard Deviation
Night Time Phase 2
|
45.5 mg/dL
Standard Deviation 10.8
|
|
Standard Deviation
Night Time Phase 3
|
48.8 mg/dL
Standard Deviation 11.7
|
|
Standard Deviation
Overall ST
|
64.9 mg/dL
Standard Deviation 13.4
|
|
Standard Deviation
Overall Phase 3
|
60.9 mg/dL
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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=80 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 Phase 3
|
38.6 percent coefficient of variation
Standard Deviation 3.7
|
|
Coefficient of Variation
Night Time ST
|
34.7 percent coefficient of variation
Standard Deviation 6.6
|
|
Coefficient of Variation
Night Time Phase 2
|
32.1 percent coefficient of variation
Standard Deviation 5.2
|
|
Coefficient of Variation
Night Time Phase 3
|
33.2 percent coefficient of variation
Standard Deviation 5.1
|
|
Coefficient of Variation
Overall ST
|
38.1 percent coefficient of variation
Standard Deviation 5.5
|
|
Coefficient of Variation
Overall Phase 2
|
37.7 percent coefficient of variation
Standard Deviation 4.0
|
|
Coefficient of Variation
Overall Phase 3
|
38.1 percent coefficient of variation
Standard Deviation 3.9
|
|
Coefficient of Variation
Day Time ST
|
38.6 percent coefficient of variation
Standard Deviation 5.7
|
|
Coefficient of Variation
Day Time Phase 2
|
38.0 percent coefficient of variation
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod).
Outcome measures
| Measure |
Treatment
n=80 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
Phase 2 Automated Mode
|
96.8 percent of time
Standard Deviation 2.6
|
|
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Phase 2 Manual Mode
|
2.8 percent of time
Standard Deviation 2.5
|
|
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Phase 3 Automated Mode
|
95.5 percent of time
Standard Deviation 3.8
|
|
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Phase 3 Manual Mode
|
3.2 percent of time
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more.
Outcome measures
| Measure |
Treatment
n=80 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)
Day Time Phase 2
|
7.21 percent of gmi
Standard Deviation 0.44
|
|
Glucose Management Indicator (GMI)
Day Time Phase 3
|
7.22 percent of gmi
Standard Deviation 0.46
|
|
Glucose Management Indicator (GMI)
Night Time ST
|
7.33 percent of gmi
Standard Deviation 0.80
|
|
Glucose Management Indicator (GMI)
Night Time Phase 2
|
6.68 percent of gmi
Standard Deviation 0.39
|
|
Glucose Management Indicator (GMI)
Night Time Phase 3
|
6.79 percent of gmi
Standard Deviation 0.40
|
|
Glucose Management Indicator (GMI)
Overall ST
|
7.40 percent of gmi
Standard Deviation 0.73
|
|
Glucose Management Indicator (GMI)
Overall Phase 2
|
7.08 percent of gmi
Standard Deviation 0.40
|
|
Glucose Management Indicator (GMI)
Overall Phase 3
|
7.12 percent of gmi
Standard Deviation 0.43
|
|
Glucose Management Indicator (GMI)
Day Time ST
|
7.43 percent of gmi
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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)
ST
|
13.7 units
Standard Deviation 4.4
|
|
Total Daily Insulin (TDI) (Units)
Phase 2
|
14.1 units
Standard Deviation 4.0
|
|
Total Daily Insulin (TDI) (Units)
Phase 3
|
16.4 units
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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/kg)
ST
|
0.69 units/kg
Standard Deviation 0.18
|
|
Total Daily Insulin (TDI) (Units/kg)
Phase 2
|
0.71 units/kg
Standard Deviation 0.15
|
|
Total Daily Insulin (TDI) (Units/kg)
Phase 3
|
0.80 units/kg
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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)
ST
|
5.6 units
Standard Deviation 2.5
|
|
Total Daily Basal Insulin (Units)
Phase 2
|
6.4 units
Standard Deviation 2.4
|
|
Total Daily Basal Insulin (Units)
Phase 3
|
7.7 units
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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/kg)
ST
|
0.28 units/kg
Standard Deviation 0.12
|
|
Total Daily Basal Insulin (Units/kg)
Phase 2
|
0.32 units/kg
Standard Deviation 0.10
|
|
Total Daily Basal Insulin (Units/kg)
Phase 3
|
0.38 units/kg
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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)
ST
|
8.1 units
Standard Deviation 3.3
|
|
Total Daily Bolus Insulin (Units)
Phase 2
|
7.7 units
Standard Deviation 2.3
|
|
Total Daily Bolus Insulin (Units)
Phase 3
|
8.7 units
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)Measure of insulin requirements
Outcome measures
| Measure |
Treatment
n=80 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/kg)
ST
|
0.41 units/kg
Standard Deviation 0.15
|
|
Total Daily Bolus Insulin (Units/kg)
Phase 2
|
0.39 units/kg
Standard Deviation 0.10
|
|
Total Daily Bolus Insulin (Units/kg)
Phase 3
|
0.42 units/kg
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baselineMeasure of change in weight
Outcome measures
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Body Mass Index (BMI) (kg/m^2)
V13
|
16.7 kg/m^2
Standard Deviation 1.4
|
|
Body Mass Index (BMI) (kg/m^2)
V23
|
16.9 kg/m^2
Standard Deviation 2.3
|
|
Body Mass Index (BMI) (kg/m^2)
Baseline
|
16.7 kg/m^2
Standard Deviation 1.5
|
Adverse Events
Treatment
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Endocrine disorders
Severe hypoglycemia
|
1.2%
1/80 • Number of events 1 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Endocrine disorders
Diabetic ketoacidosis
|
1.2%
1/80 • Number of events 1 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Endocrine disorders
Prolonged Hyperglycemia
|
1.2%
1/80 • Number of events 1 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Gastrointestinal disorders
Other
|
1.2%
1/80 • Number of events 1 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
Other adverse events
| Measure |
Treatment
n=80 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.
|
|---|---|
|
Endocrine disorders
Hypoglycemia
|
2.5%
2/80 • Number of events 2 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Endocrine disorders
Prolonged Hyperglycemia
|
32.5%
26/80 • Number of events 51 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Endocrine disorders
Hyperglycemia
|
3.8%
3/80 • Number of events 3 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
|
Endocrine disorders
Other
|
45.0%
36/80 • Number of events 52 • First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place