Trial Outcomes & Findings for Omnipod 5 System Compared to Pump Therapy (NCT NCT05409131)
NCT ID: NCT05409131
Last Updated: 2025-09-16
Results Overview
Glucose metric from study continuous glucose monitoring system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
196 participants
Primary outcome timeframe
Comparing intervention group with control group during the 13-week study phase
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
62
|
|
Overall Study
COMPLETED
|
131
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=132 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 14 • n=132 Participants
|
36 years
STANDARD_DEVIATION 13 • n=62 Participants
|
36 years
STANDARD_DEVIATION 14 • n=194 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=132 Participants
|
38 Participants
n=62 Participants
|
116 Participants
n=194 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=132 Participants
|
24 Participants
n=62 Participants
|
78 Participants
n=194 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
1 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
1 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
2 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
3 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
0 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
0 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
3 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
7 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
White
|
70 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
29 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
99 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
2 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
4 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=80 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
1 Participants
n=38 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
4 Participants
n=118 Participants • Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row.
|
|
Region of Enrollment
United States
|
80 participants
n=132 Participants
|
38 participants
n=62 Participants
|
118 participants
n=194 Participants
|
|
Region of Enrollment
France
|
52 participants
n=132 Participants
|
24 participants
n=62 Participants
|
76 participants
n=194 Participants
|
|
BMI (kg/m^2)
|
26.6 (kg/m^2)
STANDARD_DEVIATION 4.8 • n=132 Participants
|
25.4 (kg/m^2)
STANDARD_DEVIATION 4.1 • n=62 Participants
|
26.2 (kg/m^2)
STANDARD_DEVIATION 4.6 • n=194 Participants
|
|
HbA1c at Screening
|
8.5 Percentage
STANDARD_DEVIATION 0.8 • n=132 Participants
|
8.6 Percentage
STANDARD_DEVIATION 0.9 • n=62 Participants
|
8.5 Percentage
STANDARD_DEVIATION 0.8 • n=194 Participants
|
|
HbA1c ≥ 8%
|
106 Participants
n=132 Participants
|
51 Participants
n=62 Participants
|
157 Participants
n=194 Participants
|
|
Daily Insulin Dose
|
0.63 units/kg
STANDARD_DEVIATION 0.20 • n=132 Participants
|
0.59 units/kg
STANDARD_DEVIATION 0.17 • n=62 Participants
|
0.62 units/kg
STANDARD_DEVIATION 0.19 • n=194 Participants
|
|
Previous or Current CGM Use
|
124 Participants
n=132 Participants
|
59 Participants
n=62 Participants
|
183 Participants
n=194 Participants
|
|
Duration of Insulin Pump Use
|
9.5 years
STANDARD_DEVIATION 7.4 • n=132 Participants
|
9.8 years
STANDARD_DEVIATION 6.8 • n=62 Participants
|
9.6 years
STANDARD_DEVIATION 7.2 • n=194 Participants
|
PRIMARY outcome
Timeframe: Comparing intervention group with control group during the 13-week study phasePopulation: Subjects are included in the Primary Endpoint Analysis even if data for one period is missing.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Percent of Time in Range 70-180 mg/dL
Baseline
|
43.9 Percentage of time
Standard Deviation 14.0
|
41.3 Percentage of time
Standard Deviation 14.6
|
|
Percent of Time in Range 70-180 mg/dL
13 Weeks
|
61.2 Percentage of time
Standard Deviation 11.2
|
43.8 Percentage of time
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phasePopulation: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Percent of Time <54 mg/dL (Non-inferiority)
Baseline
|
0.32 Percentage of time
Standard Deviation 0.53
|
0.42 Percentage of time
Standard Deviation 0.91
|
|
Percent of Time <54 mg/dL (Non-inferiority)
13 Weeks
|
0.23 Percentage of time
Standard Deviation 0.23
|
0.37 Percentage of time
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phasePopulation: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Percent of Time >180 mg/dL
Baseline
|
54.4 Percentage of time
Standard Deviation 14.7
|
57.1 Percentage of time
Standard Deviation 15.5
|
|
Percent of Time >180 mg/dL
13 Weeks
|
37.6 Percentage of time
Standard Deviation 11.4
|
54.5 Percentage of time
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phasePopulation: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Mean Glucose
Baseline
|
200.0 mg/dL
Standard Deviation 29.5
|
204.2 mg/dL
Standard Deviation 30.7
|
|
Mean Glucose
13 Weeks
|
173.7 mg/dL
Standard Deviation 19.7
|
199.8 mg/dL
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: Baseline compared to end of study visit (Day -30 to Day 90)Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.
Measures device effectiveness
Outcome measures
| Measure |
Intervention Arm
n=119 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=55 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Change in HbA1c
|
-1.24 percentage of HbA1C
Standard Deviation 0.75
|
-0.68 percentage of HbA1C
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phasePopulation: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.
Glucose metric from study continuous glucose monitoring system
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Percent of Time <70 mg/dL
Baseline
|
1.66 Percentage of time
Standard Deviation 1.79
|
1.66 Percentage of time
Standard Deviation 2.25
|
|
Percent of Time <70 mg/dL
13 Weeks
|
1.18 Percentage of time
Standard Deviation 0.86
|
1.75 Percentage of time
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Baseline compared to end of study visit (Day -14 to Day 90)A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.
Outcome measures
| Measure |
Intervention Arm
n=130 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
|
-0.30 score on a scale
Standard Deviation 0.50
|
-0.20 score on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline compared to end of study visit (Day -14 to Day 90)A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Change in Hypoglycemic Confidence Scale (HCS) Total Score
|
0.16 score on a scale
Standard Deviation 0.52
|
0.01 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline compared to end of study visit (Day -14 to Day 90)A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome.
Outcome measures
| Measure |
Intervention Arm
n=130 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Change in Diabetes Quality of Life (DQOL)-Brief Total Score
|
0.35 score on a scale
Standard Deviation 0.44
|
-0.02 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phaseProportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups
Outcome measures
| Measure |
Intervention Arm
n=130 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Proportion of Participants With T1-DDS MCID After 13 Weeks
|
70 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phaseProportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks
Outcome measures
| Measure |
Intervention Arm
n=130 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
|
77 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Comparing intervention group with control group at the end of the 13-week study phaseSecondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5
Outcome measures
| Measure |
Intervention Arm
n=131 Participants
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=60 Participants
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
|
107 Participants
|
37 Participants
|
Adverse Events
Intervention Arm
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Arm
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Arm
n=132 participants at risk
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 participants at risk
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Injury, poisoning and procedural complications
Other
|
0.76%
1/132 • Number of events 1 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
0.00%
0/62 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/132 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
1.6%
1/62 • Number of events 1 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
Other adverse events
| Measure |
Intervention Arm
n=132 participants at risk
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
|
Control Arm
n=62 participants at risk
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system
|
|---|---|---|
|
Investigations
Other
|
3.8%
5/132 • Number of events 6 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
6.5%
4/62 • Number of events 4 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
|
Endocrine disorders
Prolonged Hyperglycemia
|
3.0%
4/132 • Number of events 4 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
6.5%
4/62 • Number of events 5 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
|
Endocrine disorders
Hyperglycemia
|
1.5%
2/132 • Number of events 2 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
0.00%
0/62 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place