Trial Outcomes & Findings for OP5-005 Using Omnipod 5 in Adults With Type 2 (NCT NCT05815342)

Results Overview

The change in HbA1c at 13 weeks from baseline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

343 participants

Primary outcome timeframe

Comparing the change in HbA1c during the 13 weeks study phase

Results posted on

2025-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Baseline, Standard Therapy (2 Weeks) STARTED	320
Baseline, Standard Therapy (2 Weeks) COMPLETED	305
Baseline, Standard Therapy (2 Weeks) NOT COMPLETED	15
Treatment Phase (13 Weeks) STARTED	305
Treatment Phase (13 Weeks) COMPLETED	289
Treatment Phase (13 Weeks) NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Baseline, Standard Therapy (2 Weeks) Ineligible	4
Baseline, Standard Therapy (2 Weeks) Withdrawal by Subject	9
Baseline, Standard Therapy (2 Weeks) Lost to Follow-up	2
Treatment Phase (13 Weeks) Withdrawal by Subject	14
Treatment Phase (13 Weeks) Lost to Follow-up	2

Baseline Characteristics

OP5-005 Using Omnipod 5 in Adults With Type 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	175 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native, not Hispanic or Latino	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander, not Hispanic or Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized Black, not Hispanic or Latino	72 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	66 Participants n=5 Participants
Race/Ethnicity, Customized White, not Hispanic or Latino	153 Participants n=5 Participants
Race/Ethnicity, Customized ≥1 Race, not Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants
BMI	35 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants
HbA1C	8.2 Percentage of HbA1C STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: Comparing the change in HbA1c during the 13 weeks study phase

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

The change in HbA1c at 13 weeks from baseline

Outcome measures

Outcome measures
Measure	Treatment n=296 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Change in HbA1c Baseline or Standard Therapy (2 weeks)	8.2 Percentage of HbA1C Standard Deviation 1.3
Change in HbA1c End of treatment or treatment phase (13 weeks)	7.4 Percentage of HbA1C Standard Deviation 0.9

SECONDARY outcome

Timeframe: Measuring mean glucose during the 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from study provided continuous glucose monitor (CGM)

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Mean Glucose Baseline or Standard Therapy (2 weeks)	202 mg/dL Standard Deviation 50
Mean Glucose End of treatment or treatment phase (13 weeks)	170 mg/dL Standard Deviation 24

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percentage of Time in Range 70-180 mg/dL Baseline or Standard Therapy (2 weeks)	45 Percent Time in Range Standard Deviation 25
Percentage of Time in Range 70-180 mg/dL End of treatment or treatment phase (13 weeks)	66 Percent Time in Range Standard Deviation 17

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from study CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 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 Baseline or Standard Therapy (2 weeks)	21 Percent Time in Range Standard Deviation 18
Percent of Time in Range 70-140 mg/dL End of treatment or treatment phase (13 weeks)	33 Percent Time in Range Standard Deviation 17

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percent of Time ≥ 300 mg/dL Baseline or Standard Therapy (2 weeks)	7.9 Percent Time in Range Standard Deviation 10.3
Percent of Time ≥ 300 mg/dL End of treatment of treatment phase (13 weeks)	7.9 Percent Time in Range Standard Deviation 2.4

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percent of Time > 250 mg/dL Baseline or Standard Therapy (2 weeks)	20 Percent Time in Range Standard Deviation 22
Percent of Time > 250 mg/dL End of treatment or treatment phase (13 weeks)	7 Percent Time in Range Standard Deviation 8

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percent of Time >180 mg/dL Baseline or Standard Therapy (2 weeks)	54 Percent Time in Range Standard Deviation 25
Percent of Time >180 mg/dL End of treatment or treatment phase (13 weeks)	34 Percent Time in Range Standard Deviation 17

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%] Baseline or Standard Therapy (2 weeks)	0.2 Percent Time in Range Standard Deviation 0.3
Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%] End of treatment or treatment phase (13 weeks)	0.2 Percent Time in Range Standard Deviation 0.2

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%] Baseline or Standard Therapy (2 weeks)	0.01 Percent Time in Range Standard Deviation 0.02
Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%] End of treatment or treatment phase (13 weeks)	0.04 Percent Time in Range Standard Deviation 0.05

SECONDARY outcome

Timeframe: Baseline compared to end of week 13 visit

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

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Change From Baseline in T2-DDAS Total Score Baseline or Standard Therapy (2 weeks)	2.5 Score Standard Deviation 1.0
Change From Baseline in T2-DDAS Total Score End of treatment or treatment phase (13 weeks)	2.2 Score Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline compared to end week 13 visit

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

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percentage Meeting MCID for T2-DDAS Baseline or Standard Therapy (2 weeks)	66 Percentage
Percentage Meeting MCID for T2-DDAS End of treatment or treatment phase (13 weeks)	55 Percentage

SECONDARY outcome

Timeframe: Baseline compared to end of week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality).

Outcome measures

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Change From Baseline in Pittsburgh Sleep Quality Index Total Score Baseline or ST (2 weeks)	7.3 score on a scale Standard Deviation 4.0
Change From Baseline in Pittsburgh Sleep Quality Index Total Score End of treatment or treatment phase (13 weeks)	7.0 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline compared to end of week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.

Outcome measures

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
% Meeting MCID for Pittsburgh Sleep Quality Index Baseline or ST (2 weeks)	63 Percentage
% Meeting MCID for Pittsburgh Sleep Quality Index End of treatment or treatment phase (13 weeks)	59 Percentage

SECONDARY outcome

Timeframe: Baseline compared to end week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

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

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Change From Baseline in HCS Total Score End of treatment or treatment phase (13 weeks)	3.3 score on a scale Standard Deviation 0.6
Change From Baseline in HCS Total Score Baseline of Standard Therapy (2 weeks)	3.2 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline compared to end week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

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

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
% Meeting MCID for HCS Baseline or Standard Therpey (2 weeks)	32 Percentage
% Meeting MCID for HCS End of treatment or treatment phase (13 weeks)	0.2 Percentage

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percentage of Time <70 mg/dL (Superiority) Baseline or Standard Therapy (2 weeks)	0.2 Percent Time in Range Standard Deviation 0.3
Percentage of Time <70 mg/dL (Superiority) End of treatment or treatment phase (13 weeks)	0.2 Percent Time in Range Standard Deviation 0.2

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure	Treatment n=305 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Percentage of Time <54 mg/dL (Superiority) Baseline or ST (2 weeks)	0.01 Percent Time in Range Standard Deviation 0.02
Percentage of Time <54 mg/dL (Superiority) End of treatment or treatment phase (13 weeks)	0.04 Percent Time in Range Standard Deviation 0.05

SECONDARY outcome

Timeframe: Measured during 13 weeks study phase and compared to standard therapy

Population: Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.

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

Outcome measures
Measure	Treatment n=299 Participants All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Coefficient of Variation End of treatment or treatment phase (13 weeks)	27.1 Percent coefficient of variation Standard Deviation 5.1
Coefficient of Variation Baseline or Standard Therapy (2 weeks)	27.8 Percent coefficient of variation Standard Deviation 6.3

Adverse Events

Standard Therapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment

Serious events: 13 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Therapy n=320 participants at risk Adverse events collected during the 2-week Baseline or Standard Therapy Phase.	Treatment n=305 participants at risk Adverse events collected during the 13-week treatment phase while wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Endocrine disorders Severe hypoglycemia	0.31% 1/320 • Number of events 1 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.	0.00% 0/305 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.
General disorders Nonglycemic serious adverse events	0.00% 0/320 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.	4.3% 13/305 • Number of events 13 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.

Other adverse events

Other adverse events
Measure	Standard Therapy n=320 participants at risk Adverse events collected during the 2-week Baseline or Standard Therapy Phase.	Treatment n=305 participants at risk Adverse events collected during the 13-week treatment phase while wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Gastrointestinal disorders Nonserious adverse event	0.94% 3/320 • Number of events 3 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.	14.1% 43/305 • Number of events 53 • Adverse events were collected from the start of standard therapy until the end of the 13-week treatment phase.

Additional Information

Dr. Trang Ly

Insulet Corporation

Phone: 9786007628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place