Type 2 Diabetes MellitusSTRIVE 2NCT07579702
Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
A study testing Omnipod 5 System and Omnipod 6 System in people with Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, run by Insulet Corporation at 11 sites in United States.
Trial summary
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- What is being tested?
- Omnipod 5 System and Omnipod 6 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 May 2026to 24 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent 14-75 years (inclusive)
- Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
- Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
- HbA1c ≥ 7.5%
- Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
- Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
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- Currently using a continuous glucose monitor
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
- Participant agrees to provide their own insulin for the duration of the study
- Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
- Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
- If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
- Willing to wear the system continuously throughout the study
- Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged < 18 years per local regulatory requirements
- Able to read and understand English and operate the study device in English
- If of childbearing potential, willing and able to have pregnancy testing
Who cannot join
- Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
- Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
- Any planned surgery during the study which could be considered major in the judgment of the investigator
- History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
- History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
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- Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
- Use of hydroxyurea
- Plans to receive blood transfusion over the course of the study
- Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
- Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
- Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
- Pregnant or lactating, or 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 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
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bonnie Dumais, RN contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Sabeena Usman
Georgia Davis
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Estella Escobar, (720) 305-7817, Estella.Escobar@cuanschutz.edu
Gregory Forlenza
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Louise Ambler-Osborn, 617-975-8206, louise.ambler-osborn@joslin.harvard.edu
Lori Laffel
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Evelyn Fronczyk, 312-908-9002, Evelyn.guevara@northwestern.ed
Grazia Aleppo
- Recruiting
Henry Ford Health Systems
Detroit, Michigan, 48202
Lydia Oehring, +1 (313) 916-3906, loehrin1@hfhs.org
Davida Kruger
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Anh Nguyen, (832) 822-3870, Anh.Nguyen2@bcm.edu
Daniel DeSalvo
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Kathy Bohanan, 317-278-0651, kkremer@iu.edu
Viral Shah
- Recruiting
University of Southern California
Los Angeles, California, 90022
Martha Walker, 323-605-4442, mawalker@usc.edu
Anne Peters
- Recruiting
Health Partners
Minneapolis, Minnesota, 55416
Stephanie Zimmerman, 952-993-2048, H.Zimmerman@HealthPartners.com
Amy Criego
- Recruiting
Yale
New Haven, Connecticut, 06511
Amy Steffen, 203-737-8852, amy.steffen@yale.edu
Amy Steffen
- Recruiting
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Juliana Lopez, 8057059465, jlopez@sansum.org
Kristin Castorino
About this study
Official title: Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
Read the detailed description
Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.
After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses
- Conditions
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- Being tested
- Omnipod 5 System, Omnipod 6 System
- Keywords
- Omnipod, Automated Insulin Delivery, T2D, T1D, Type 2 Diabetes, Type 1 Diabetes, AID
- Medical subject headings
- Diabetes Mellitus, Type 2, 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
The Omnipod 5 System with the study CGM
Omnipod 6 SystemDevice
The Omnipod 6 System with the study CGM
| Study group | Role | What they receive |
|---|---|---|
| Omnipod 5 System | Active comparator | Not described Receives: Device: Omnipod 5 System |
| Omnipod 6 System | Experimental | Not described Receives: Device: Omnipod 6 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range 70-180 mg/dL
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Time <54 mg/dL
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Time <70 mg/dL
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Time >180 mg/dL
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Time in Range 70-140 mg/dL
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
HbA1c
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Mean sensor glucose
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Time >250 mg/dL
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Secondary outcomes (23)
Total boluses per day
Total blues per day will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Total daily insulin per kg and total insulin delivered via automation
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Percentage of time in automated mode
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Percentage with HbA1c <7.0% and <7.5%
Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Percentage with >= 70% time in range
Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Percentage with >= 50% time in range
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Diabetes treatment satisfaction
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
Measured: 13 weeks
System Usability
Patient Reported Outcome Survey evaluated at the end of each 13-week period
Measured: 13 weeks
System Opinion
Patient Reported Outcome Survey evaluated at the end of each 13-week period
Measured: 13 weeks
Health Related Quality of Life (HR-QOL)
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
Measured: 13 weeks
Hypoglycemia confidence
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
Measured: 13 weeks
Missed Meal - Peak glucose
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - AUC
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - Time in Range
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - Percentage of Time <54 mg/dL
Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Missed Meal - Percentage of Time <70 mg/dL
Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
Measured: 13 weeks
Number of severe hypoglycemic events
Measured: 13 weeks
Number of DKA or HHS events
Measured: 13 weeks
Other related serious adverse events
Measured: 13 weeks
Unanticipated adverse device effects
Measured: 13 weeks
Reportable device-related adverse events
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start13 May 2026
- Primary completion22 Feb 2027 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579702
- Sponsor's protocol ID
- STRIVE 2
- Acronym
- STRIVE 2
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia
- ClinicalTrials.gov ID
- NCT07579702
- Acronym / sponsor ID
- STRIVE 2 / STRIVE 2
- Conditions
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- Keywords
- Omnipod, Automated Insulin Delivery, T2D, T1D, Type 2 Diabetes, Type 1 Diabetes, AID
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
Detailed description
Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.
After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnipod 5 System | Active comparator | Device: Omnipod 5 System |
| Omnipod 6 System | Experimental | Device: Omnipod 6 System |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Age at time of consent 14-75 years (inclusive)
- Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
- Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
- HbA1c ≥ 7.5%
- Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
Key exclusion criteria (16 listed)
- Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
- Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
- Any planned surgery during the study which could be considered major in the judgment of the investigator
- History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
- History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
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 SystemThe Omnipod 5 System with the study CGM | Device | Omnipod 5 System |
| Omnipod 6 SystemThe Omnipod 6 System with the study CGM | Device | Omnipod 6 System |
Primary outcome
Time in Range 70-180 mg/dL
Time frame: 13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
Time <54 mg/dL
Time frame: 13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
Time <70 mg/dL
Time frame: 13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
Time >180 mg/dL
Time frame: 13 weeks
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
Time in Range 70-140 mg/dL
Time frame: 13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
HbA1c
Time frame: 13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
Mean sensor glucose
Time frame: 13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
Time >250 mg/dL
Time frame: 13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
23 secondary outcomes
Total boluses per day
Time frame: 13 weeks
Total daily insulin per kg and total insulin delivered via automation
Time frame: 13 weeks
Percentage of time in automated mode
Time frame: 13 weeks
Percentage with HbA1c <7.0% and <7.5%
Time frame: 13 weeks
Percentage with >= 70% time in range
Time frame: 13 weeks
Percentage with >= 50% time in range
Time frame: 13 weeks
Diabetes treatment satisfaction
Time frame: 13 weeks
System Usability
Time frame: 13 weeks
System Opinion
Time frame: 13 weeks
Health Related Quality of Life (HR-QOL)
Time frame: 13 weeks
Hypoglycemia confidence
Time frame: 13 weeks
Missed Meal - Peak glucose
Time frame: 13 weeks
Missed Meal - AUC
Time frame: 13 weeks
Missed Meal - Time in Range
Time frame: 13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
Time frame: 13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
Time frame: 13 weeks
Missed Meal - Percentage of Time <54 mg/dL
Time frame: 13 weeks
Missed Meal - Percentage of Time <70 mg/dL
Time frame: 13 weeks
Number of severe hypoglycemic events
Time frame: 13 weeks
Number of DKA or HHS events
Time frame: 13 weeks
Other related serious adverse events
Time frame: 13 weeks
Unanticipated adverse device effects
Time frame: 13 weeks
Reportable device-related adverse events
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Bonnie Dumais, RN contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipod 5 System and Omnipod 6 System in people with Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, run by Insulet Corporation at 11 sites in United States.
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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trang Ly, MBBS, PhD (978-600-7000, APClinical@insulet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range 70-180 mg/dL (time frame: 13 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.