Diabetes Mellitus, Type 1, Type 2STRIVENCT06865989
Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
A study testing Omnipod 5 SmartAdjust 2.0 System and Omnipod 5 System in people with Diabetes Mellitus, Type 1, Type 2, run by Insulet Corporation at 11 sites in United States.
Trial summary
The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 2
- What is being tested?
- Omnipod 5 SmartAdjust 2.0 System and Omnipod 5 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 11 sitesUnited States
- Study dates
- 26 Mar 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent 2-70 years (inclusive)
- Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
- Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - < 7 years and at least 1 year for participants aged 7 - 70 years. OR 18-70 years old, diagnosed with type 2 diabetes for at least 1 year
- Living with a parent or guardian if < 18 years old
- Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
- Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit
Show all 14Show fewer
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
- Participant agrees to provide their own insulin for the duration of the study
- Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator
- Investigator has confidence that the participant and/or caregiver 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) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged < 18 years per state requirements
- Able to read and understand 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
Show all 15Show fewer
- 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
- 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
- For type 1 participants only. Use of non-insulin glucose-lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose during study participation
- 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)
- In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other clinical study during this study period.
- Planned international travel during the study
- 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.
11 sites in 1 country
United States11 sites
University of Colorado Denver
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
University Hospitals Cleveland
Cleveland, Ohio, 44106
Henry Ford
Detroit, Michigan, 48202
Baylor College of Medicine
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90022
International Diabetes Center
Minneapolis, Minnesota, 55416
Yale University School of Medicine
New Haven, Connecticut, 06511
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes.
Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting.
Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.
- Conditions
- Diabetes Mellitus, Type 1, Type 2
- Being tested
- Omnipod 5 SmartAdjust 2.0 System, Omnipod 5 System
- Keywords
- T1D, Omnipod, Omnipod 5, T2D
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5 SmartAdjust 2.0 SystemDevice
Omnipod 5 System with changes
Omnipod 5 SystemDevice
Cleared device as comparator
| Study group | Role | What they receive |
|---|---|---|
| Omnipod 5 SmartAdjust 2.0 System | Experimental | A subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system. Receives: Device: Omnipod 5 SmartAdjust 2.0 System; Device: Omnipod 5 System |
| Omnipod 5 System | Active comparator | A subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study. Receives: Device: Omnipod 5 SmartAdjust 2.0 System; Device: Omnipod 5 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)
Glucose metric from continuous glucose monitoring system
Measured: End of Period 2 (Day 56) compared to Baseline
Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)
Glucose metric from continuous glucose monitoring system
Measured: End of Period 2 (Day 56) compared to Baseline
Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)
Glucose metric from continuous glucose monitoring system
Measured: End of Period 2 (Day 56) compared to Baseline
Mean Glucose (non-inferiority margin of 8 mg/dL)
Glucose metric from continuous glucose monitoring system
Measured: End of Period 2 (Day 56) compared to Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start26 Mar 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1, Type 2Studies 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
- Model description
- Randomized two-sequence, multi-center crossover study
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Forlenza, MD, Study chair, Barbara Davis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865989
- Sponsor's protocol ID
- STRIVE
- Acronym
- STRIVE
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06865989
- Acronym / sponsor ID
- STRIVE / STRIVE
- Conditions
- Diabetes Mellitus, Type 1, Type 2
- Keywords
- T1D, Omnipod, Omnipod 5, T2D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 10 Mar 2025 (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.
The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes.
Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting.
Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized two-sequence, multi-center crossover study
| Arm | Type | Receives |
|---|---|---|
| Omnipod 5 SmartAdjust 2.0 System | Experimental | Device: Omnipod 5 SmartAdjust 2.0 System, Device: Omnipod 5 SystemA subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system. |
| Omnipod 5 System | Active comparator | Device: Omnipod 5 SmartAdjust 2.0 System, Device: Omnipod 5 SystemA subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Age at time of consent 2-70 years (inclusive)
- Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
- Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - < 7 years and at least 1 year for participants aged 7 - 70 years. OR 18-70 years old, diagnosed with type 2 diabetes for at least 1 year
- Living with a parent or guardian if < 18 years old
- Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
Key exclusion criteria (15 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 SmartAdjust 2.0 SystemOmnipod 5 System with changes | Device | Omnipod 5 SmartAdjust 2.0 System, Omnipod 5 System |
| Omnipod 5 SystemCleared device as comparator | Device | Omnipod 5 SmartAdjust 2.0 System, Omnipod 5 System |
Primary outcome
Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)
Time frame: End of Period 2 (Day 56) compared to Baseline
Glucose metric from continuous glucose monitoring system
Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)
Time frame: End of Period 2 (Day 56) compared to Baseline
Glucose metric from continuous glucose monitoring system
Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)
Time frame: End of Period 2 (Day 56) compared to Baseline
Glucose metric from continuous glucose monitoring system
Mean Glucose (non-inferiority margin of 8 mg/dL)
Time frame: End of Period 2 (Day 56) compared to Baseline
Glucose metric from continuous glucose monitoring system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Related trials for Diabetes Mellitus, Type 1, Type 2
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
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.
Gregory Forlenza, MD study chair
Barbara Davis Center
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 SmartAdjust 2.0 System and Omnipod 5 System in people with Diabetes Mellitus, Type 1, Type 2, 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 14 inclusion and 15 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 18 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 <54 mg/dL (non-inferiority margin of 0.75%) (time frame: End of Period 2 (Day 56) compared to Baseline). The study lists 4 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 18 Dec 2025.