Trial Outcomes & Findings for Pivotal Omnipod Horizon™ Automated Glucose Control System (NCT NCT04196140)

NCT ID: NCT04196140

Last Updated: 2025-04-03

Results Overview

Measure of serious device-related adverse events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 240 participants
• Primary outcome timeframe: Phase 2 hybrid closed-loop (94 days)
• Results posted on: 2025-04-03

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
Phase 2 STARTED	240
Phase 2 COMPLETED	235
Phase 2 NOT COMPLETED	5
Phase 3 STARTED	224
Phase 3 COMPLETED	208
Phase 3 NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivotal Omnipod Horizon™ Automated Glucose Control System

Baseline characteristics by cohort

Measure	Treatment n=240 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	24.5 years STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants
Race/Ethnicity, Customized White	228 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	18 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	4 Participants n=5 Participants
BMI	22.8 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days)

Measure of serious device-related adverse events

Outcome measures

Measure	Treatment n=240 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)	.004 events per person month

PRIMARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days)

Measure of serious device-related adverse events

Outcome measures

Measure	Treatment n=240 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)	.001 events per person month

PRIMARY outcome

Timeframe: 6 weeks continuous Phase 2 participation compared to baseline

Measures device effectiveness

Outcome measures

Measure	Treatment n=240 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 percentage of HbA1C Standard Deviation 0.9
Glycated Hemoglobin (A1C) Phase 2	6.9 percentage of HbA1C Standard Deviation 0.7

PRIMARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Measures device effectiveness

Outcome measures

Measure	Treatment n=240 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	58.6 % Time in Range Standard Deviation 17.5
Time in Range 70-180 mg/dL Day Time Phase 2	68.8 % Time in Range Standard Deviation 10.7
Time in Range 70-180 mg/dL Night Time ST	60.1 % Time in Range Standard Deviation 19.8
Time in Range 70-180 mg/dL Night Time Phase 2	78.1 % Time in Range Standard Deviation 12.6
Time in Range 70-180 mg/dL Overall ST	59.0 % Time in Range Standard Deviation 17.2
Time in Range 70-180 mg/dL Overall Phase 2	71.2 % Time in Range Standard Deviation 10.2

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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 Day Time ST	39 % Time in Range Standard Deviation 18.4
Percent of Time >180 mg/dL Day Time HCL	29.5 % Time in Range Standard Deviation 11
Percent of Time >180 mg/dL Night Time ST	36.8 % Time in Range Standard Deviation 20.7
Percent of Time >180 mg/dL Night Time HCL	20.7 % Time in Range Standard Deviation 12.6
Percent of Time >180 mg/dL Overall ST	38.5 % Time in Range Standard Deviation 18.1
Percent of Time >180 mg/dL Overall HCL	27.3 % Time in Range Standard Deviation 10.5

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	2.4 % Time in Range Standard Deviation 2.78
Percent of Time <70 mg/dL Day Time HCL	1.66 % Time in Range Standard Deviation 1.38
Percent of Time <70 mg/dL Night Time ST	3.11 % Time in Range Standard Deviation 4.39
Percent of Time <70 mg/dL Night Time HCL	1.17 % Time in Range Standard Deviation 1.23
Percent of Time <70 mg/dL Overall ST	2.57 % Time in Range Standard Deviation 2.90
Percent of Time <70 mg/dL Overall HCL	1.53 % Time in Range Standard Deviation 1.25

SECONDARY outcome

Timeframe: at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days)

Measures device effectiveness

Outcome measures

Measure	Treatment n=240 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) 6 months	6.8 % A1C Standard Deviation 0.6
Glycated Hemoglobin (A1C) 12 months	7.1 % A1C Standard Deviation 0.7
Glycated Hemoglobin (A1C) 6 Weeks Baseline	7.4 % A1C Standard Deviation 0.9
Glycated Hemoglobin (A1C) 6 Weeks Phase 2	6.7 % A1C Standard Deviation 0.6
Glycated Hemoglobin (A1C) 8 Weeks Baseline	7.4 % A1C Standard Deviation 0.9
Glycated Hemoglobin (A1C) 8 Weeks Phase 2	6.9 % A1C Standard Deviation 0.7

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	172.7 mg/dL Standard Deviation 32.2
Mean Glucose Day Time Phase 2	159.4 mg/dL Standard Deviation 17.1
Mean Glucose Day Time Phase 3	162.2 mg/dL Standard Deviation 19.7
Mean Glucose Night Time ST	167.8 mg/dL Standard Deviation 35.4
Mean Glucose Night Time Phase 2	148.9 mg/dL Standard Deviation 19.2
Mean Glucose Night Time Phase 3	150.8 mg/dL Standard Deviation 19.3
Mean Glucose Overall ST	171.5 mg/dL Standard Deviation 31.7
Mean Glucose Overall Phase 2	156.7 mg/dL Standard Deviation 16.3
Mean Glucose Overall Phase 3	159.3 mg/dL Standard Deviation 18.4

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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 70-180 mg/dL Day Time Phase 2	68.8 Percent Time in Range Standard Deviation 10.7
Percent of Time in Range 70-180 mg/dL Day Time Phase 3	67.0 Percent Time in Range Standard Deviation 11.5
Percent of Time in Range 70-180 mg/dL Night Time ST	60.1 Percent Time in Range Standard Deviation 19.8
Percent of Time in Range 70-180 mg/dL Night Time Phase 2	78.1 Percent Time in Range Standard Deviation 12.6
Percent of Time in Range 70-180 mg/dL Night Time Phase 3	76.6 Percent Time in Range Standard Deviation 12.5
Percent of Time in Range 70-180 mg/dL Overall ST	59.0 Percent Time in Range Standard Deviation 17.2
Percent of Time in Range 70-180 mg/dL Overtime Phase 2	71.2 Percent Time in Range Standard Deviation 10.2
Percent of Time in Range 70-180 mg/dL Overtime Phase 3	69.4 Percent Time in Range Standard Deviation 10.8
Percent of Time in Range 70-180 mg/dL Day Time ST	58.6 Percent Time in Range Standard Deviation 17.5

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	36.0 Percent Time in Range Standard Deviation 15.3
Percent of Time in Range 70-140 mg/dL Day Time Phase 2	43.7 Percent Time in Range Standard Deviation 10.6
Percent of Time in Range 70-140 mg/dL Day Time Phase 3	42.6 Percent Time in Range Standard Deviation 11.1
Percent of Time in Range 70-140 mg/dL Night Time ST	38.2 Percent Time in Range Standard Deviation 19.0
Percent of Time in Range 70-140 mg/dL Night Time Phase 2	52.8 Percent Time in Range Standard Deviation 15.5
Percent of Time in Range 70-140 mg/dL Night Time Phase 3	51.9 Percent Time in Range Standard Deviation 14.4
Percent of Time in Range 70-140 mg/dL Overall ST	36.6 Percent Time in Range Standard Deviation 15.4
Percent of Time in Range 70-140 mg/dL Overall Phase 2	46.0 Percent Time in Range Standard Deviation 10.7
Percent of Time in Range 70-140 mg/dL Overall Phase 3	45.0 Percent Time in Range Standard Deviation 10.8

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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 Day Time ST	39.0 Percent Time in Range Standard Deviation 18.4
Percent of Time >180 mg/dL Day Time Phase 2	29.5 Percent Time in Range Standard Deviation 11.0
Percent of Time >180 mg/dL Day Time Phase 3	31.3 Percent Time in Range Standard Deviation 11.9
Percent of Time >180 mg/dL Night Time ST	36.8 Percent Time in Range Standard Deviation 20.7
Percent of Time >180 mg/dL Night Time Phase 2	20.7 Percent Time in Range Standard Deviation 12.6
Percent of Time >180 mg/dL Night Time Phase 3	22.0 Percent Time in Range Standard Deviation 12.6
Percent of Time >180 mg/dL Overall ST	38.5 Percent Time in Range Standard Deviation 18.1
Percent of Time >180 mg/dL Overall Phase 2	27.3 Percent Time in Range Standard Deviation 10.5
Percent of Time >180 mg/dL Overall Phase 3	28.9 Percent Time in Range Standard Deviation 11.2

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	14.7 Percent Time in Range Standard Deviation 12.9
Percent of Time ≥ 250 mg/dL Day Time Phase 2	8.4 Percent Time in Range Standard Deviation 6.3
Percent of Time ≥ 250 mg/dL Night Time ST	13.2 Percent Time in Range Standard Deviation 14.0
Percent of Time ≥ 250 mg/dL Night Time Phase 2	5.1 Percent Time in Range Standard Deviation 6.2
Percent of Time ≥ 250 mg/dL Overall ST	14.3 Percent Time in Range Standard Deviation 12.5
Percent of Time ≥ 250 mg/dL Overall Phase 2	7.6 Percent Time in Range Standard Deviation 5.8
Percent of Time ≥ 250 mg/dL Day Time Phase 3	9.8 Percent Time in Range Standard Deviation 7.4
Percent of Time ≥ 250 mg/dL Night Time Phase 3	6.1 Percent Time in Range Standard Deviation 6.1
Percent of Time ≥ 250 mg/dL Overall Phase 3	8.9 Percent Time in Range Standard Deviation 6.7

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	6.2 Percent Time in Range Standard Deviation 7.9
Percent of Time ≥ 300 mg/dL Day Time Phase 2	2.8 Percent Time in Range Standard Deviation 3.1
Percent of Time ≥ 300 mg/dL Day Time Phase 3	3.7 Percent Time in Range Standard Deviation 4.2
Percent of Time ≥ 300 mg/dL Night Time ST	5.4 Percent Time in Range Standard Deviation 8.6
Percent of Time ≥ 300 mg/dL Night Time Phase 2	1.7 Percent Time in Range Standard Deviation 2.8
Percent of Time ≥ 300 mg/dL Night Time Phase 3	2.2 Percent Time in Range Standard Deviation 3.4
Percent of Time ≥ 300 mg/dL Overall ST	6.0 Percent Time in Range Standard Deviation 7.7
Percent of Time ≥ 300 mg/dL Overall Phase 2	2.5 Percent Time in Range Standard Deviation 2.8
Percent of Time ≥ 300 mg/dL Overall Phase 3	3.3 Percent Time in Range Standard Deviation 3.9

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	2.40 Percent Time in Range Standard Deviation 2.78
Percent of Time < 70 mg/dL Day Time Phase 2	1.66 Percent Time in Range Standard Deviation 1.38
Percent of Time < 70 mg/dL Day Time Phase 3	1.75 Percent Time in Range Standard Deviation 1.50
Percent of Time < 70 mg/dL Night Time ST	3.11 Percent Time in Range Standard Deviation 4.39
Percent of Time < 70 mg/dL Night Time Phase 2	1.17 Percent Time in Range Standard Deviation 1.23
Percent of Time < 70 mg/dL Night Time Phase 3	1.38 Percent Time in Range Standard Deviation 1.46
Percent of Time < 70 mg/dL Overall ST	2.57 Percent Time in Range Standard Deviation 2.90
Percent of Time < 70 mg/dL Overall Phase 2	1.53 Percent Time in Range Standard Deviation 1.25
Percent of Time < 70 mg/dL Overall Phase 3	1.66 Percent Time in Range Standard Deviation 1.38

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=240 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	0.44 Percent Time in Range Standard Deviation 0.99
Percent of Time < 54 mg/dL Day Time Phase 2	0.29 Percent Time in Range Standard Deviation 0.32
Percent of Time < 54 mg/dL Day Time Phase 3	0.33 Percent Time in Range Standard Deviation 0.38
Percent of Time < 54 mg/dL Night Time ST	0.77 Percent Time in Range Standard Deviation 1.77
Percent of Time < 54 mg/dL Night Time Phase 2	0.23 Percent Time in Range Standard Deviation 0.35
Percent of Time < 54 mg/dL Night Time Phase 3	0.34 Percent Time in Range Standard Deviation 0.51
Percent of Time < 54 mg/dL Overall ST	0.52 Percent Time in Range Standard Deviation 1.07
Percent of Time < 54 mg/dL Overall Phase 2	0.27 Percent Time in Range Standard Deviation 0.30
Percent of Time < 54 mg/dL Overall Phase 3	0.33 Percent Time in Range Standard Deviation 0.37

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)

Outcome measures

Measure	Treatment n=240 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) Day Time ST	62.4 mg/dL Standard Deviation 15.2
Standard Deviation (of Glucose) Day Time Phase 2	55.5 mg/dL Standard Deviation 11.9
Standard Deviation (of Glucose) Day Time Phase 3	57.9 mg/dL Standard Deviation 13.3
Standard Deviation (of Glucose) Night Time ST	58.3 mg/dL Standard Deviation 16.3
Standard Deviation (of Glucose) Night Time Phase 2	45.6 mg/dL Standard Deviation 12.8
Standard Deviation (of Glucose) Night Time Phase 3	49.0 mg/dL Standard Deviation 13.9
Standard Deviation (of Glucose) Overall ST	62.3 mg/dL Standard Deviation 14.9
Standard Deviation (of Glucose) Overall Phase 2	53.9 mg/dL Standard Deviation 11.6
Standard Deviation (of Glucose) Overall Phase 3	56.5 mg/dL Standard Deviation 13.0

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

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	Treatment n=240 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 Coefficient of Variation (of Glucose) Day Time ST	36.1 Percent coefficient of variation Standard Deviation 5.7
Percent Coefficient of Variation (of Glucose) Day Time Phase 2	34.6 Percent coefficient of variation Standard Deviation 5.2
Percent Coefficient of Variation (of Glucose) Day Time Phase 3	35.4 Percent coefficient of variation Standard Deviation 5.2
Percent Coefficient of Variation (of Glucose) Night Time ST	34.9 Percent coefficient of variation Standard Deviation 7.5
Percent Coefficient of Variation (of Glucose) Night Time Phase 2	30.3 Percent coefficient of variation Standard Deviation 5.9
Percent Coefficient of Variation (of Glucose) Night Time Phase 3	32.1 Percent coefficient of variation Standard Deviation 6.2
Percent Coefficient of Variation (of Glucose) Overall ST	36.3 Percent coefficient of variation Standard Deviation 5.6
Percent Coefficient of Variation (of Glucose) Overall Phase 2	34.2 Percent coefficient of variation Standard Deviation 5.1
Percent Coefficient of Variation (of Glucose) Overall Phase 3	35.2 Percent coefficient of variation Standard Deviation 5.2

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of system usage

Outcome measures

Measure	Treatment n=240 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	95 Percent time spent Standard Deviation 5.2
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time Phase 2 Manual Mode	4.2 Percent time spent Standard Deviation 4.7
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time Phase 3 Automated Mode	93.6 Percent time spent Standard Deviation 7.7
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time Phase 3 Manual Mode	4.9 Percent time spent Standard Deviation 6.9

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

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. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of <7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more).

Outcome measures

Measure	Treatment n=240 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 Glucose Management Indicator (% GMI) Day Time ST	7.44 Percent GMI Standard Deviation 0.77
Percent Glucose Management Indicator (% GMI) Day Time Phase 2	7.12 Percent GMI Standard Deviation 0.41
Percent Glucose Management Indicator (% GMI) Day Time Phase 3	7.19 Percent GMI Standard Deviation 0.47
Percent Glucose Management Indicator (% GMI) Night Time ST	7.32 Percent GMI Standard Deviation 0.85
Percent Glucose Management Indicator (% GMI) Night Time Phase 2	6.87 Percent GMI Standard Deviation 0.46
Percent Glucose Management Indicator (% GMI) Night Time Phase 3	6.92 Percent GMI Standard Deviation 0.46
Percent Glucose Management Indicator (% GMI) Overall ST	7.41 Percent GMI Standard Deviation 0.76
Percent Glucose Management Indicator (% GMI) Overall Phase 2	7.06 Percent GMI Standard Deviation 0.39
Percent Glucose Management Indicator (% GMI) Overall Phase 3	7.12 Percent GMI Standard Deviation 0.44

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	41.7 units of insulin Standard Deviation 20.6
Total Daily Insulin (TDI) (Units) Phase 2	42.1 units of insulin Standard Deviation 19.3
Total Daily Insulin (TDI) (Units) Phase 3	46.3 units of insulin Standard Deviation 20.1

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	0.72 units of insulin/kg Standard Deviation 0.26
Total Daily Insulin (TDI) (Units/kg) Phase 2	0.75 units of insulin/kg Standard Deviation 0.28
Total Daily Insulin (TDI) (Units/kg) Phase 3	0.81 units of insulin/kg Standard Deviation 0.32

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	19.7 units of insulin Standard Deviation 10.7
Total Daily Basal Insulin (Units) Phase 2	21.4 units of insulin Standard Deviation 10.5
Total Daily Basal Insulin (Units) Phase 3	24.3 units of insulin Standard Deviation 10.8

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	0.33 units of insulin/kg Standard Deviation 0.12
Total Daily Basal Insulin (Units/kg) Phase 2	0.38 units of insulin/kg Standard Deviation 0.15
Total Daily Basal Insulin (Units/kg) Phase 3	0.43 units of insulin/kg Standard Deviation 0.18

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	21.8 units of insulin Standard Deviation 12.7
Total Daily Bolus Insulin (Units) Phase 2	20.7 units of insulin Standard Deviation 10.1
Total Daily Bolus Insulin (Units) Phase 3	22.0 units of insulin Standard Deviation 10.9

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of insulin requirements

Outcome measures

Measure	Treatment n=240 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	0.39 units of insulin/kg Standard Deviation 0.19
Total Daily Bolus Insulin (Units/kg) Phase 2	0.37 units of insulin/kg Standard Deviation 0.15
Total Daily Bolus Insulin (Units/kg) Phase 3	0.38 units of insulin/kg Standard Deviation 0.17

SECONDARY outcome

Timeframe: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to baseline

Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.

Measure of change in weight

Outcome measures

Measure	Treatment n=240 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) Baseline	22.8 kg/m^2 Standard Deviation 5.7
Body Mass Index (BMI) (kg/m^2) Phase 2	23.0 kg/m^2 Standard Deviation 5.5
Body Mass Index (BMI) (kg/m^2) Phase 3	23.8 kg/m^2 Standard Deviation 5.6

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge)

Measure of device safety

Outcome measures

Measure	Treatment n=50 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 Hypoglycemia (<70 mg/dL Confirmed by BG) Exercise in Automated Mode without use of HypoProtect.	40.8 Percentage with hypoglycemia events
Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) Hpt-60 (HypoProtect started 60 min before exercise.)	34.7 Percentage with hypoglycemia events
Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) HPt-30 (HypoProtect started 30 min before exercise.)	36.0 Percentage with hypoglycemia events

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Number of hypoglycemic events less than 70mg/dL which was confirmed with a blood glucose reading.

Outcome measures

Measure	Treatment n=50 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
Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) Automated Mode	23 Number of events
Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) HPt-60	19 Number of events
Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) HPt-30	19 Number of events

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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
Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) Automated Mode	58.3 hours x mg/dL Standard Deviation 144.7
Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) HPt-60	34.0 hours x mg/dL Standard Deviation 83.9
Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) HPt-30	34.3 hours x mg/dL Standard Deviation 77.6

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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
Minimum Continuous Glucose Monitor Value (Nadir Glucose) Automated Mode	83.9 mg/dL Standard Deviation 25.0
Minimum Continuous Glucose Monitor Value (Nadir Glucose) HPt-60	94.9 mg/dL Standard Deviation 33.1
Minimum Continuous Glucose Monitor Value (Nadir Glucose) HPt-30	93.8 mg/dL Standard Deviation 32.8

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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
Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) HPt-60	30.0 hours x mg/dL Standard Deviation 113.0
Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) Automated Mode	66.7 hours x mg/dL Standard Deviation 243.4
Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) HPt-30	82.8 hours x mg/dL Standard Deviation 400.7

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) Automated Mode	58.1 mg/dL Standard Deviation 35.0
Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) HPt-60	47.8 mg/dL Standard Deviation 35.6
Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) HPt-30	42.0 mg/dL Standard Deviation 37.2

OTHER_PRE_SPECIFIED outcome

Timeframe: HypoProtect compared to Automated Mode (3-day exercise challenge)

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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
Carbohydrates Consumed During Exercise (Grams) Automated Mode	12.0 grams Standard Deviation 15.5
Carbohydrates Consumed During Exercise (Grams) HPt-60	10.1 grams Standard Deviation 14.2
Carbohydrates Consumed During Exercise (Grams) HPt-30	8.8 grams Standard Deviation 12.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Glucose metric from study continuous glucose monitoring system (CGM)

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	117.6 mg/dL Standard Deviation 20.7
Mean Glucose During Exercise HPt-60	123.2 mg/dL Standard Deviation 26.9
Mean Glucose During Exercise HPt-30	119.7 mg/dL Standard Deviation 28.9
Mean Glucose End of exercise through 4 hours post exercise Automated Mode	150.6 mg/dL Standard Deviation 39.7
Mean Glucose End of exercise through 4 hours post exercise HPt-60	156.9 mg/dL Standard Deviation 34.5
Mean Glucose End of exercise through 4 hours post exercise HPt-30	167.2 mg/dL Standard Deviation 45.8
Mean Glucose End of exercise through 12 hours post exercise Automated Mode	156.7 mg/dL Standard Deviation 34.5
Mean Glucose End of exercise through 12 hours post exercise HPt-60	153.6 mg/dL Standard Deviation 28.4
Mean Glucose End of exercise through 12 hours post exercise HPt-30	155.2 mg/dL Standard Deviation 36.2
Mean Glucose End of exercise through 24 hours post exercise Automated Mode	150.8 mg/dL Standard Deviation 25.7
Mean Glucose End of exercise through 24 hours post exercise HPt-60	150.0 mg/dL Standard Deviation 24.1
Mean Glucose End of exercise through 24 hours post exercise HPt-30	151.4 mg/dL Standard Deviation 26.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 70-180 mg/dL 24 Hours Post Exercise HPt-30	75.1 Percent of time Standard Deviation 16.6
Percent of Time in Range 70-180 mg/dL During Exercise Automated Mode	88.9 Percent of time Standard Deviation 16.4
Percent of Time in Range 70-180 mg/dL During Exercise HPt-60	90.4 Percent of time Standard Deviation 14.3
Percent of Time in Range 70-180 mg/dL During Exercise HPt-30	89.5 Percent of time Standard Deviation 20.8
Percent of Time in Range 70-180 mg/dL 4-Hours Post Exercise Automated Mode	69.4 Percent of time Standard Deviation 26.9
Percent of Time in Range 70-180 mg/dL 4-Hours Post Exercise HPt-60	66.9 Percent of time Standard Deviation 24.8
Percent of Time in Range 70-180 mg/dL 4-Hours Post Exercise HPt-30	66.6 Percent of time Standard Deviation 27.6
Percent of Time in Range 70-180 mg/dL 12 hours Post Exercise Automated Mode	67.3 Percent of time Standard Deviation 23.8
Percent of Time in Range 70-180 mg/dL 12 Hours Post Exercise HPt-60	70.1 Percent of time Standard Deviation 20.2
Percent of Time in Range 70-180 mg/dL 12 Hours Post Exercise HPt-30	71.3 Percent of time Standard Deviation 22.1
Percent of Time in Range 70-180 mg/dL 24 Hours Post Exercise Automated Mode	74.2 Percent of time Standard Deviation 17.1
Percent of Time in Range 70-180 mg/dL 24 Hours Post Exercise HPt-60	74.7 Percent of time Standard Deviation 17.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	4.5 Percent of time Standard Deviation 11.4
Percent of Time > 180 mg/dL During Exercise HPt-60	4.5 Percent of time Standard Deviation 13.0
Percent of Time > 180 mg/dL During Exercise HPt-30	4.6 Percent of time Standard Deviation 18.6
Percent of Time > 180 mg/dL 4 Hours Post Exercise Automated Mode	27.9 Percent of time Standard Deviation 28.0
Percent of Time > 180 mg/dL 4 Hours Post Exercise HPt-60	30.9 Percent of time Standard Deviation 25.9
Percent of Time > 180 mg/dL 4 Hours Post Exercise HPt-30	31.7 Percent of time Standard Deviation 28.0
Percent of Time > 180 mg/dL 12 Hours Post Exercise Automated Mode	30.5 Percent of time Standard Deviation 24.1
Percent of Time > 180 mg/dL 12 Hours Post Exercise HPt-60	27.3 Percent of time Standard Deviation 19.9
Percent of Time > 180 mg/dL 12 Hours Post Exercise HPt-30	26.4 Percent of time Standard Deviation 22.9
Percent of Time > 180 mg/dL 24 Hours Post Exercise Automated Mode	24.1 Percent of time Standard Deviation 17.5
Percent of Time > 180 mg/dL 24 Hours Post Exercise HPt-60	23.3 Percent of time Standard Deviation 16.9
Percent of Time > 180 mg/dL 24 Hours Post Exercise HPt-30	23.1 Percent of time Standard Deviation 16.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	0.3 Percent of time Standard Deviation 2.3
Percent of Time ≥ 250 mg/dL During Exercise HPt-60	0.0 Percent of time Standard Deviation 0.0
Percent of Time ≥ 250 mg/dL During Exercise HPt-30	0.0 Percent of time Standard Deviation 0.0
Percent of Time ≥ 250 mg/dL 4 Hours Post Exercise Automated Mode	6.3 Percent of time Standard Deviation 14.7
Percent of Time ≥ 250 mg/dL 4 Hours Post Exercise HPt-60	4.5 Percent of time Standard Deviation 12.6
Percent of Time ≥ 250 mg/dL 4 Hours Post Exercise HPt-30	12.0 Percent of time Standard Deviation 21.2
Percent of Time ≥ 250 mg/dL 12 Hours Post Exercise Automated Mode	7.0 Percent of time Standard Deviation 12.9
Percent of Time ≥ 250 mg/dL 12 Hours Post Exercise HPt-60	7.1 Percent of time Standard Deviation 11.2
Percent of Time ≥ 250 mg/dL 12 Hours Post Exercise HPt-30	8.4 Percent of time Standard Deviation 12.4
Percent of Time ≥ 250 mg/dL 24 Hours Post Exercise Automated Mode	5.3 Percent of time Standard Deviation 8.5
Percent of Time ≥ 250 mg/dL 24 Hours Post Exercise HPt-60	5.8 Percent of time Standard Deviation 8.8
Percent of Time ≥ 250 mg/dL 24 Hours Post Exercise HPt-30	7.0 Percent of time Standard Deviation 9.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	0.0 percent of time Standard Deviation 0.0
Percent of Time ≥ 300 mg/dL During Exercise HPt-60	0.0 percent of time Standard Deviation 0.0
Percent of Time ≥ 300 mg/dL During Exercise HPt-30	0.0 percent of time Standard Deviation 0.0
Percent of Time ≥ 300 mg/dL 4 Hours Post Exercise Automated Mode	1.4 percent of time Standard Deviation 5.6
Percent of Time ≥ 300 mg/dL 4 Hours Post Exercise HPt-60	1.8 percent of time Standard Deviation 8.8
Percent of Time ≥ 300 mg/dL 4 Hours Post Exercise HPt-30	5.3 percent of time Standard Deviation 13.9
Percent of Time ≥ 300 mg/dL 12 Hours Post Exercise Automated Mode	2.4 percent of time Standard Deviation 8.1
Percent of Time ≥ 300 mg/dL 12 Hours Post Exercise HPt-60	2.5 percent of time Standard Deviation 6.0
Percent of Time ≥ 300 mg/dL 12 Hours Post Exercise HPt-30	3.3 percent of time Standard Deviation 8.0
Percent of Time ≥ 300 mg/dL 24 Hours Post Exercise Automated Mode	1.6 percent of time Standard Deviation 5.1
Percent of Time ≥ 300 mg/dL 24 Hours Post Exercise HPt-60	1.7 percent of time Standard Deviation 4.7
Percent of Time ≥ 300 mg/dL 24 Hours Post Exercise HPt-30	2.2 percent of time Standard Deviation 4.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	6.52 Percent of time Standard Deviation 12.27
Percent of Time < 70 mg/dL During Exercise HPt-60	5.12 Percent of time Standard Deviation 9.06
Percent of Time < 70 mg/dL During Exercise HPt-30	5.88 Percent of time Standard Deviation 11.60
Percent of Time < 70 mg/dL 4 Hours Post Exercise Automated Mode	2.72 Percent of time Standard Deviation 5.99
Percent of Time < 70 mg/dL 4 Hours Post Exercise HPt-60	2.17 Percent of time Standard Deviation 5.19
Percent of Time < 70 mg/dL 4 Hours Post Exercise HPt-30	1.68 Percent of time Standard Deviation 3.98
Percent of Time < 70 mg/dL 12 Hours Post Exercise Automated Mode	2.21 Percent of time Standard Deviation 3.42
Percent of Time < 70 mg/dL 12 Hours Post Exercise HPt-60	2.65 Percent of time Standard Deviation 4.33
Percent of Time < 70 mg/dL 12 Hours Post Exercise HPt-30	2.33 Percent of time Standard Deviation 4.81
Percent of Time < 70 mg/dL 24 Hours Post Exercise Automated Mode	1.72 Percent of time Standard Deviation 2.32
Percent of Time < 70 mg/dL 24 Hours Post Exercise HPt-60	2.00 Percent of time Standard Deviation 3.01
Percent of Time < 70 mg/dL 24 Hours Post Exercise HPt-30	1.78 Percent of time Standard Deviation 3.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Measure of device effectiveness

Outcome measures

Measure	Treatment n=50 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 During Exercise Automated Mode	1.40 Percent of time Standard Deviation 4.96
Percent of Time < 54 mg/dL During Exercise HPT-60	0.52 Percent of time Standard Deviation 2.12
Percent of Time < 54 mg/dL During Exercise HPT-30	0.37 Percent of time Standard Deviation 1.47
Percent of Time < 54 mg/dL 4 Hours Post Exercise Automated Mode	0.38 Percent of time Standard Deviation 1.89
Percent of Time < 54 mg/dL 4 Hours Post Exercise HPt-60	0.60 Percent of time Standard Deviation 2.04
Percent of Time < 54 mg/dL 4 Hours Post Exercise HPt-30	0.26 Percent of time Standard Deviation 0.93
Percent of Time < 54 mg/dL 12 Hours Post Exercise Automated Mode	0.40 Percent of time Standard Deviation 1.17
Percent of Time < 54 mg/dL 12 Hours Post Exercise HPt-60	0.62 Percent of time Standard Deviation 1.82
Percent of Time < 54 mg/dL 12 Hours Post Exercise HPt-30	0.70 Percent of time Standard Deviation 2.66
Percent of Time < 54 mg/dL 24 Hours Post Exercise Automated Mode	0.26 Percent of time Standard Deviation 0.71
Percent of Time < 54 mg/dL 24 Hours Post Exercise HPt-60	0.41 Percent of time Standard Deviation 1.07
Percent of Time < 54 mg/dL 24 Hours Post Exercise HPt-30	0.44 Percent of time Standard Deviation 1.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)

Outcome measures

Measure	Treatment n=50 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) During Exercise Automated Mode	24.8 mg/dL Standard Deviation 13.8
Standard Deviation (of Glucose) During Exercise HPt-60	19.8 mg/dL Standard Deviation 11.6
Standard Deviation (of Glucose) During Exercise HPt-30	19.1 mg/dL Standard Deviation 11.3
Standard Deviation (of Glucose) 4 Hours Post Exercise Automated Mode	39.7 mg/dL Standard Deviation 17.7
Standard Deviation (of Glucose) 4 Hours Post Exercise HPt-60	37.2 mg/dL Standard Deviation 16.1
Standard Deviation (of Glucose) 4 Hours Post Exercise HPt-30	42.1 mg/dL Standard Deviation 24.2
Standard Deviation (of Glucose) 12 Hours Post Exercise Automated Mode	45.4 mg/dL Standard Deviation 19.0
Standard Deviation (of Glucose) 12 Hours Post Exercise HPt-60	47.0 mg/dL Standard Deviation 20.0
Standard Deviation (of Glucose) 12 Hours Post Exercise HPt-30	46.3 mg/dL Standard Deviation 19.0
Standard Deviation (of Glucose) 24 Hours Post Exercise Automated Mode	44.2 mg/dL Standard Deviation 15.3
Standard Deviation (of Glucose) 24 Hours Post Exercise HPt-60	45.1 mg/dL Standard Deviation 17.5
Standard Deviation (of Glucose) 24 Hours Post Exercise HPt-30	46.7 mg/dL Standard Deviation 16.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

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	Treatment n=50 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 (of Glucose) During Exercise Automated Mode	21.6 Percent coefficient of variation Standard Deviation 11.7
Coefficient of Variation (of Glucose) During Exercise HPT-60	17.1 Percent coefficient of variation Standard Deviation 10.4
Coefficient of Variation (of Glucose) During Exercise HPT-30	17.2 Percent coefficient of variation Standard Deviation 11.2
Coefficient of Variation (of Glucose) 4 Hours Post Exercise Automated Mode	25.9 Percent coefficient of variation Standard Deviation 8.5
Coefficient of Variation (of Glucose) 4 Hours Post Exercise HPt-60	23.6 Percent coefficient of variation Standard Deviation 8.4
Coefficient of Variation (of Glucose) 4 Hours Post Exercise HPt-30	24.5 Percent coefficient of variation Standard Deviation 10.7
Coefficient of Variation (of Glucose) 12 Hours Post Exercise Automated Mode	28.5 Percent coefficient of variation Standard Deviation 8.1
Coefficient of Variation (of Glucose) 12 Hours Post Exercise HPt-60	30.0 Percent coefficient of variation Standard Deviation 9.8
Coefficient of Variation (of Glucose) 12 Hours Post Exercise HPt-30	29.3 Percent coefficient of variation Standard Deviation 8.6
Coefficient of Variation (of Glucose) 24 Hours Post Exercise Automated Mode	28.8 Percent coefficient of variation Standard Deviation 6.3
Coefficient of Variation (of Glucose) 24 Hours Post Exercise HPt-60	29.5 Percent coefficient of variation Standard Deviation 8.6
Coefficient of Variation (of Glucose) 24 Hours Post Exercise HPt-30	30.4 Percent coefficient of variation Standard Deviation 7.5

Adverse Events

Phase 2

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Phase 3

Serious events: 19 serious events

Other events: 107 other events

Deaths: 1 deaths

Serious adverse events

Measure	Phase 2 n=240 participants at risk Subjects during the standard therapy phase (N=240) and phase 2 (N=240). During phase 2 subjects were using the Omnipod Horizon Automated Glucose Control System using the closed-loop algorithm.	Phase 3 n=224 participants at risk Subjects during phase 3 (N=224). During Phase 3 subjects were using the Omnipod Horizon Automated Glucose Control System using the closed-loop algorithm.
Endocrine disorders Severe Hypoglycemia	1.2% 3/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	3.1% 7/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Endocrine disorders Diabetic Ketoacidosis	0.42% 1/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	0.45% 1/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Investigations Other	0.83% 2/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	4.0% 9/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Endocrine disorders Hypoglycemia	0.00% 0/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	0.45% 1/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Endocrine disorders Prolonged Hyperglycemia	0.00% 0/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	0.45% 1/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.

Other adverse events

Measure	Phase 2 n=240 participants at risk Subjects during the standard therapy phase (N=240) and phase 2 (N=240). During phase 2 subjects were using the Omnipod Horizon Automated Glucose Control System using the closed-loop algorithm.	Phase 3 n=224 participants at risk Subjects during phase 3 (N=224). During Phase 3 subjects were using the Omnipod Horizon Automated Glucose Control System using the closed-loop algorithm.
Endocrine disorders Hypoglycemia	0.42% 1/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	0.00% 0/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Endocrine disorders Prolonged Hyperglycemia	7.5% 18/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	17.9% 40/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Investigations Other	5.8% 14/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	25.9% 58/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.
Endocrine disorders Hyperglycemia	1.2% 3/240 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.	4.0% 9/224 • Start of phase 2 (13 weeks) until the end of phase 3 (12 months). Adverse events listed below were collected during phase 2 and phase 3.

Additional Information

Dr. Trang Ly

Insulet Corporation

Phone: 9786007628

Email: tly@insulet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place