Omnipod 5 System Compared to Pump Therapy

A study testing Omnipod 5 System in people with Type 1 Diabetes, run by Insulet Corporation at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Omnipod 5 System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 14 sitesin 2 countries
Study dates: 7 Jul 2022to 10 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age at time of consent 18-70 years of age
Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
A1C 7.0-11.0% by point-of-care taken at screening visit
Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study

Show all 9Show fewer

Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
Willing to wear the system continuously throughout the study
Willing and able to sign the Informed Consent Form (ICF)

Who cannot join

Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk
History of severe hypoglycemia in the past 6 months
History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

Show all 11Show fewer

Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation.
Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner)
Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other study during this study period
Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States10 sites

Atlanta Diabetes
Atlanta, Georgia, 30318
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22903
University of Colorado Denver
Denver, Colorado, 80045
Northwestern University
Evanston, Illinois, 60208
Stanford University School of Medicine
Palo Alto, California, 94304
Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
University of Washington
Seattle, Washington, 98109
State University of New York, Upstate Medical University
Syracuse, New York, 13244

Other trials in United States

France4 sites

Hopital Sud-Francilien
Corbeil-Essonnes
Hospices Civils de Lyon - Centre du diabete Diab-eCare
Lyon
CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition
Montpellier
Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications
Paris

Other trials in France

About this study

Official title: Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial

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

Read the detailed description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.

Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.

Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.

Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.

Conditions: Type 1 Diabetes
Being tested: Omnipod 5 System
Keywords: T1D, Omnipod, Automated Insulin Delivery
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omnipod 5 SystemDevice
Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.

Study groups in NCT05409131
Study group	Role	What they receive
Intervention Arm	Active comparator	Omnipod 5 System with Dexcom G6 continuous glucose monitoring system Receives: Device: Omnipod 5 System
Control Arm	No intervention	Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing intervention group with control group during the 13-week study phase

Secondary outcomes (11)

Percent of Time <54 mg/dL (Non-inferiority)
Glucose metric from study continuous glucose monitoring system
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Percent of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Mean Glucose
Glucose metric from study continuous glucose monitoring system
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Change in HbA1c
Measures device effectiveness
Measured: Baseline compared to end of study visit (Day -30 to Day 90)
Percent of Time <70 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
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.
Measured: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Hypoglycemic Confidence Scale (HCS) Total Score
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.
Measured: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Diabetes Quality of Life (DQOL)-Brief Total Score
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.
Measured: Baseline compared to end of study visit (Day -14 to Day 90)
Proportion of Participants With T1-DDS MCID After 13 Weeks
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
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks
Measured: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5
Measured: Comparing intervention group with control group at the end of the 13-week study phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202210 Jan 2025

First posted8 Jun 2022
Study start7 Jul 2022
Primary completion14 Sep 2023
Study completion10 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05409131
Sponsor's protocol ID: OP5-003 (G6 CSII)
Status last verified: Aug 2025
First submitted: 3 Jun 2022
Last updated: 16 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Renard E, Weinstock RS, Penfornis A, Riveline JP, Thivolet C, Ly TT; OP5-003 Research Group. Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial. Endocrinol Diabetes Metab. 2026 Sep;9(5):e70321. doi: 10.1002/edm2.70321.
PubMed 42671087

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial
ClinicalTrials.gov ID: NCT05409131
Acronym / sponsor ID: OP5-003 (G6 CSII)
Conditions: Type 1 Diabetes
Keywords: T1D, Omnipod, Automated Insulin Delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Insulet CorporationIndustry (pharma, biotech, devices)
Study start: 7 Jul 2022 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 10 Jan 2025 (actual)
First posted: 8 Jun 2022 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.

Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Arm	Active comparator	Device: Omnipod 5 SystemOmnipod 5 System with Dexcom G6 continuous glucose monitoring system
Control Arm	No intervention	–Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age at time of consent 18-70 years of age
Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
A1C 7.0-11.0% by point-of-care taken at screening visit
Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment

Key exclusion criteria (11 listed)

Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk
History of severe hypoglycemia in the past 6 months
History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omnipod 5 SystemOmnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.	Device	Intervention Arm

Primary outcome

Percent of Time in Range 70-180 mg/dL
Time frame: Comparing intervention group with control group during the 13-week study phase
Glucose metric from study continuous glucose monitoring system

11 secondary outcomes

Percent of Time <54 mg/dL (Non-inferiority)
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Percent of Time >180 mg/dL
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Mean Glucose
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Change in HbA1c
Time frame: Baseline compared to end of study visit (Day -30 to Day 90)
Percent of Time <70 mg/dL
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Hypoglycemic Confidence Scale (HCS) Total Score
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Change in Diabetes Quality of Life (DQOL)-Brief Total Score
Time frame: Baseline compared to end of study visit (Day -14 to Day 90)
Proportion of Participants With T1-DDS MCID After 13 Weeks
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
Time frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
Time frame: Comparing intervention group with control group at the end of the 13-week study phase

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	132	131
Control Arm	62	21

Primary outcome: Percent of Time in Range 70-180 mg/dL

Time frame: Comparing intervention group with control group during the 13-week study phase. Mean (Standard Deviation). Unit: Percentage of time

Measure	Intervention Arm n = 131	Control Arm n = 62
Baseline	43.9 (14.0)	41.3 (14.6)
13 Weeks	61.2 (11.2)	43.8 (14.5)

Population analysed: Subjects are included in the Primary Endpoint Analysis even if data for one period is missing.

11 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	1 of 132 (0.8%)	11 of 132 (8.3%)	0 of 132
Control Arm	1 of 62 (1.6%)	8 of 62 (12.9%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42671087Renard E, Weinstock RS, Penfornis A, Riveline JP, Thivolet C, Ly TT; OP5-003 Research Group. Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial. Endocrinol Diabetes Metab. 2026 Sep;9(5):e70321. doi: 10.1002/edm2.70321.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruth Weinstock, MD study chair

State University of New York - Upstate Medical University

Eric Renard, Pr study chair

Lapeyronie Montpellier University Hospital

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Omnipod 5 System in people with Type 1 Diabetes, run by Insulet Corporation at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Time in Range 70-180 mg/dL (time frame: Comparing intervention group with control group during the 13-week study phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.