NCT05409131

Omnipod 5 System Compared to Pump Therapy

Completed NA Results posted Last updated 16 September 2025

What this trial tests

NA trial testing Omnipod 5 System in Type 1 Diabetes in 196 participants. Completed in 10 January 2025.

Timeline

7 July 2022

Primary endpoint
14 September 2023

10 January 2025

Quick facts

Lead sponsor	Insulet Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	196
Start date	7 July 2022
Primary completion	14 September 2023
Estimated completion	10 January 2025
Sites	14 locations across France, United States

Drugs / interventions tested

• Omnipod 5 System

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Insulet Corporation — full company profile →

Who can join

Adults 18 to 70, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Time in Range 70-180 mg/dL Primary · Comparing intervention group with control group during the 13-week study phase

Glucose metric from study continuous glucose monitoring system

Baseline

Group	Value	95% CI
Intervention Arm	43.9	± 14.0
Control Arm	41.3	± 14.6

13 Weeks

Group	Value	95% CI
Intervention Arm	61.2	± 11.2
Control Arm	43.8	± 14.5

Percent of Time <54 mg/dL (Non-inferiority) Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Glucose metric from study continuous glucose monitoring system

Baseline

Group	Value	95% CI
Intervention Arm	0.32	± 0.53
Control Arm	0.42	± 0.91

13 Weeks

Group	Value	95% CI
Intervention Arm	0.23	± 0.23
Control Arm	0.37	± 0.53

Percent of Time >180 mg/dL Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Glucose metric from study continuous glucose monitoring system

Baseline

Group	Value	95% CI
Intervention Arm	54.4	± 14.7
Control Arm	57.1	± 15.5

13 Weeks

Group	Value	95% CI
Intervention Arm	37.6	± 11.4
Control Arm	54.5	± 15.4

Mean Glucose Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Glucose metric from study continuous glucose monitoring system

Baseline

Group	Value	95% CI
Intervention Arm	200.0	± 29.5
Control Arm	204.2	± 30.7

13 Weeks

Group	Value	95% CI
Intervention Arm	173.7	± 19.7
Control Arm	199.8	± 30.3

Change in HbA1c Secondary · Baseline compared to end of study visit (Day -30 to Day 90)

Measures device effectiveness

Group	Value	95% CI
Intervention Arm	-1.24	± 0.75
Control Arm	-0.68	± 0.93

Percent of Time <70 mg/dL Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Glucose metric from study continuous glucose monitoring system

Baseline

Group	Value	95% CI
Intervention Arm	1.66	± 1.79
Control Arm	1.66	± 2.25

13 Weeks

Group	Value	95% CI
Intervention Arm	1.18	± 0.86
Control Arm	1.75	± 1.68

Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score Secondary · 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.

Group	Value	95% CI
Intervention Arm	-0.30	± 0.50
Control Arm	-0.20	± 0.47

Change in Hypoglycemic Confidence Scale (HCS) Total Score Secondary · 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.

Group	Value	95% CI
Intervention Arm	0.16	± 0.52
Control Arm	0.01	± 0.49

Change in Diabetes Quality of Life (DQOL)-Brief Total Score Secondary · 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.

Group	Value	95% CI
Intervention Arm	0.35	± 0.44
Control Arm	-0.02	± 0.45

Proportion of Participants With T1-DDS MCID After 13 Weeks Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Proportion 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

Group	Value	95% CI
Intervention Arm	70
Control Arm	27

Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks

Group	Value	95% CI
Intervention Arm	77
Control Arm	13

Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks Secondary · Comparing intervention group with control group at the end of the 13-week study phase

Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5

Group	Value	95% CI
Intervention Arm	107
Control Arm	37

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 1/132 (1%)

Deaths: 0/132

Control Arm

Serious: 1/62 (2%)

Deaths: 0/62

Serious adverse events (2 terms)

Reaction	System	Intervention Arm	Control Arm
Other	Injury, poisoning and procedural complications	—	—
Severe Hypoglycemia	Endocrine disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Intervention Arm	Control Arm
Other	Investigations	—	—
Prolonged Hyperglycemia	Endocrine disorders	—	—
Hyperglycemia	Endocrine disorders	—	—

Most-reported serious reactions: Other, Severe Hypoglycemia.

Data from ClinicalTrials.gov NCT05409131 adverse events section.

Sponsor's own description

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial.
   Renard E, Weinstock RS, Aleppo G, Bode BW, et al · · 2024 · cited 30× · PMID 39423118 · DOI 10.2337/dc24-1550
2. Psychosocial outcomes among adults with type 1 diabetes using a tubeless automated insulin delivery system compared with sensor augmented pump therapy: A randomised, parallel-group clinical trial sub-study.
   Riveline JP, Renard E, Aleppo G, Bode BW, et al · · 2026 · PMID 41508715 · DOI 10.1111/dom.70416