Trial Outcomes & Findings for Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study (NCT NCT04320069)
NCT ID: NCT04320069
Last Updated: 2023-11-13
Results Overview
Glucose metric from continuous glucose monitoring system (CGM)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Omnipod Horizon™ Automated Glucose Control System
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Phase 1: Omnipod Horizon™ Without CGM
STARTED
|
25
|
|
Phase 1: Omnipod Horizon™ Without CGM
COMPLETED
|
25
|
|
Phase 1: Omnipod Horizon™ Without CGM
NOT COMPLETED
|
0
|
|
Phase 2: Omnipod Horizon™ With CGM
STARTED
|
25
|
|
Phase 2: Omnipod Horizon™ With CGM
COMPLETED
|
25
|
|
Phase 2: Omnipod Horizon™ With CGM
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Baseline characteristics by cohort
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 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
|
23.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time <70 mg/dL
Phase 1
|
2.8 Percent Time in Range
Standard Deviation 2.7
|
|
Percentage of Time <70 mg/dL
Phase 2
|
2.1 Percent Time in Range
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time >180 mg/dL
Phase 1
|
32.1 Percent Time in Range
Standard Deviation 15.7
|
|
Percentage of Time >180 mg/dL
Phase 2
|
34.0 Percent Time in Range
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Mean Glucose
Phase 1
|
158.7 mg/dL
Standard Deviation 21.3
|
|
Mean Glucose
Phase 2
|
163.3 mg/dL
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time <54 mg/dL
Phase 1
|
0.5 Percent Time in Range
Standard Deviation 1.0
|
|
Percentage of Time <54 mg/dL
Phase 2
|
0.3 Percent Time in Range
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time ≥ 250 mg/dL
Phase 1
|
8.2 Percent Time in Range
Standard Deviation 6.9
|
|
Percentage of Time ≥ 250 mg/dL
Phase 2
|
9.7 Percent Time in Range
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time ≥ 300 mg/dL
Phase 1
|
2.0 Percent Time in Range
Standard Deviation 2.6
|
|
Percentage of Time ≥ 300 mg/dL
Phase 2
|
2.6 Percent Time in Range
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)Glucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time in Range 70-180 mg/dL
Phase 1
|
65.1 Percent Time in Range
Standard Deviation 15.4
|
|
Percentage of Time in Range 70-180 mg/dL
Phase 2
|
63.8 Percent Time in Range
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Mean Glucose
Day Time Phase 1
|
150.1 mg/dL
Standard Deviation 18.1
|
|
Mean Glucose
Day Time Phase 2
|
152.8 mg/dL
Standard Deviation 20.7
|
|
Mean Glucose
Night Time Phase 1
|
151.4 mg/dL
Standard Deviation 27.7
|
|
Mean Glucose
Night Time Phase 2
|
155.6 mg/dL
Standard Deviation 28.3
|
|
Mean Glucose
Overall Phase 1
|
150.4 mg/dL
Standard Deviation 18.9
|
|
Mean Glucose
Overall Phase 2
|
153.5 mg/dL
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time <54 mg/dL
Day Time Phase 1
|
0.5 Percent Time in Range
Standard Deviation 0.8
|
|
Percentage of Time <54 mg/dL
Day Time Phase 2
|
0.3 Percent Time in Range
Standard Deviation 0.7
|
|
Percentage of Time <54 mg/dL
Night Time Phase 1
|
0.3 Percent Time in Range
Standard Deviation 0.9
|
|
Percentage of Time <54 mg/dL
Night Time Phase 2
|
0.4 Percent Time in Range
Standard Deviation 0.7
|
|
Percentage of Time <54 mg/dL
Overall Phase 1
|
0.4 Percent Time in Range
Standard Deviation 0.7
|
|
Percentage of Time <54 mg/dL
Overall Phase 2
|
0.4 Percent Time in Range
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time <70 mg/dL
Day Time Phase 1
|
2.9 Percent Time in Range
Standard Deviation 2.7
|
|
Percentage of Time <70 mg/dL
Day Time Phase 2
|
2.7 Percent Time in Range
Standard Deviation 2.2
|
|
Percentage of Time <70 mg/dL
Night Time Phase 1
|
2.8 Percent Time in Range
Standard Deviation 4.1
|
|
Percentage of Time <70 mg/dL
Night Time Phase 2
|
2.7 Percent Time in Range
Standard Deviation 3.7
|
|
Percentage of Time <70 mg/dL
Overall Phase 1
|
2.9 Percent Time in Range
Standard Deviation 2.3
|
|
Percentage of Time <70 mg/dL
Overall Phase 2
|
2.7 Percent Time in Range
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time >180 mg/dL
Day Time Phase 1
|
25.9 Percent Time in Range
Standard Deviation 13.5
|
|
Percentage of Time >180 mg/dL
Day Time Phase 2
|
26.8 Percent Time in Range
Standard Deviation 14.2
|
|
Percentage of Time >180 mg/dL
Night Time Phase 1
|
26.9 Percent Time in Range
Standard Deviation 18.9
|
|
Percentage of Time >180 mg/dL
Night Time Phase 2
|
26.9 Percent Time in Range
Standard Deviation 19.0
|
|
Percentage of Time >180 mg/dL
Overall Phase 1
|
26.2 Percent Time in Range
Standard Deviation 13.7
|
|
Percentage of Time >180 mg/dL
Overall Phase 2
|
26.8 Percent Time in Range
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time ≥ 250 mg/dL
Day Time Phase 1
|
6.3 Percent Time in Range
Standard Deviation 4.9
|
|
Percentage of Time ≥ 250 mg/dL
Day Time Phase 2
|
7.0 Percent Time in Range
Standard Deviation 8.3
|
|
Percentage of Time ≥ 250 mg/dL
Night Time Phase 1
|
6.3 Percent Time in Range
Standard Deviation 8.3
|
|
Percentage of Time ≥ 250 mg/dL
Night Time Phase 2
|
8.2 Percent Time in Range
Standard Deviation 11.2
|
|
Percentage of Time ≥ 250 mg/dL
Overall Phase 1
|
6.3 Percent Time in Range
Standard Deviation 5.1
|
|
Percentage of Time ≥ 250 mg/dL
Overall Phase 2
|
7.3 Percent Time in Range
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time ≥ 300 mg/dL
Day Time Phase 1
|
1.4 Percent Time in Range
Standard Deviation 1.9
|
|
Percentage of Time ≥ 300 mg/dL
Day Time Phase 2
|
1.9 Percent Time in Range
Standard Deviation 2.8
|
|
Percentage of Time ≥ 300 mg/dL
Night Time Phase 1
|
1.5 Percent Time in Range
Standard Deviation 3.4
|
|
Percentage of Time ≥ 300 mg/dL
Night Time Phase 2
|
1.8 Percent Time in Range
Standard Deviation 3.5
|
|
Percentage of Time ≥ 300 mg/dL
Overall Phase 1
|
1.4 Percent Time in Range
Standard Deviation 1.8
|
|
Percentage of Time ≥ 300 mg/dL
Overall Phase 2
|
1.8 Percent Time in Range
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time in Range 70-180 mg/dL
Day Time Phase 1
|
71.1 Percent Time in Range
Standard Deviation 13.4
|
|
Percentage of Time in Range 70-180 mg/dL
Day Time Phase 2
|
70.6 Percent Time in Range
Standard Deviation 14.3
|
|
Percentage of Time in Range 70-180 mg/dL
Night Time Phase 1
|
70.3 Percent Time in Range
Standard Deviation 17.2
|
|
Percentage of Time in Range 70-180 mg/dL
Night Time Phase 2
|
70.4 Percent Time in Range
Standard Deviation 18.8
|
|
Percentage of Time in Range 70-180 mg/dL
Overall Phase 1
|
70.9 Percent Time in Range
Standard Deviation 13.2
|
|
Percentage of Time in Range 70-180 mg/dL
Overall Phase 2
|
70.6 Percent Time in Range
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from continuous glucose monitoring system (CGM)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Percentage of Time in Range 70-140 mg/dL
Day Time Phase 1
|
47.4 Percent Time in Range
Standard Deviation 13.9
|
|
Percentage of Time in Range 70-140 mg/dL
Day Time Phase 2
|
45.8 Percent Time in Range
Standard Deviation 15.2
|
|
Percentage of Time in Range 70-140 mg/dL
Night Time Phase 1
|
46.5 Percent Time in Range
Standard Deviation 18.1
|
|
Percentage of Time in Range 70-140 mg/dL
Night Time Phase 2
|
42.1 Percent Time in Range
Standard Deviation 18.5
|
|
Percentage of Time in Range 70-140 mg/dL
Overall Phase 1
|
47.2 Percent Time in Range
Standard Deviation 13.8
|
|
Percentage of Time in Range 70-140 mg/dL
Overall Phase 2
|
44.9 Percent Time in Range
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Standard Deviation
Day Time Phase 1
|
52.1 mg/dL
Standard Deviation 12.2
|
|
Standard Deviation
Day Time Phase 2
|
51.4 mg/dL
Standard Deviation 12.8
|
|
Standard Deviation
Night Time Phase 1
|
47.3 mg/dL
Standard Deviation 15.6
|
|
Standard Deviation
Night Time Phase 2
|
47.2 mg/dL
Standard Deviation 16.7
|
|
Standard Deviation
Overall Phase 1
|
51.9 mg/dL
Standard Deviation 12.1
|
|
Standard Deviation
Overall Phase 2
|
51.6 mg/dL
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overallGlucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Outcome measures
| Measure |
Omnipod Horizon™ Automated Glucose Control System
n=25 Participants
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Coefficient of Variation
Day Time Phase 1
|
34.6 Percent coefficient of variation
Standard Deviation 6.6
|
|
Coefficient of Variation
Day Time Phase 2
|
33.5 Percent coefficient of variation
Standard Deviation 6.7
|
|
Coefficient of Variation
Night Time Phase 1
|
31.0 Percent coefficient of variation
Standard Deviation 7.1
|
|
Coefficient of Variation
Night Time Phase 2
|
30.0 Percent coefficient of variation
Standard Deviation 8.0
|
|
Coefficient of Variation
Overall Phase 1
|
34.3 Percent coefficient of variation
Standard Deviation 5.8
|
|
Coefficient of Variation
Overall Phase 2
|
33.4 Percent coefficient of variation
Standard Deviation 6.3
|
Adverse Events
Single
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single
n=25 participants at risk
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
|
|---|---|
|
Renal and urinary disorders
Pyelonephritis
|
4.0%
1/25 • First day of Phase 1 to last day of Phase 2, an average of 14 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place