Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
NCT ID: NCT06865989
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2025-03-26
2025-11-10
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Omnipod 5 SmartAdjust 2.0 System
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.
Omnipod 5 SmartAdjust 2.0 System
Omnipod 5 System with changes
Omnipod 5 System
Cleared device as comparator
Omnipod 5 System
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.
Omnipod 5 SmartAdjust 2.0 System
Omnipod 5 System with changes
Omnipod 5 System
Cleared device as comparator
Interventions
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Omnipod 5 SmartAdjust 2.0 System
Omnipod 5 System with changes
Omnipod 5 System
Cleared device as comparator
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Living with a parent or guardian if \< 18 years old
4. 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
5. 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
6. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
7. Participant agrees to provide their own insulin for the duration of the study
8. 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
9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
10. Willing to wear the system continuously throughout the study
11. 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
12. Able to read and understand English
13. If of childbearing potential, willing and able to have pregnancy testing
Exclusion Criteria
2. 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
3. Any planned surgery during the study which could be considered major in the judgment of the investigator
4. 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.
5. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
7. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
8. Use of hydroxyurea
9. 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
10. 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
11. 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)
12. 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.
13. Planned international travel during the study
14. 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
15. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned
2 Years
70 Years
ALL
No
Sponsors
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Insulet Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Forlenza, MD
Role: STUDY_CHAIR
Barbara Davis Center
Locations
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University of Southern California
Los Angeles, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford
Detroit, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Countries
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Other Identifiers
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STRIVE
Identifier Type: -
Identifier Source: org_study_id