Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

Last updated: June 10, 2025
Sponsor: Insulet Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

Omnipod 5 SmartAdjust 2.0 System

Omnipod 5 System

Clinical Study ID

NCT06865989
STRIVE
  • Ages 2-70
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age at time of consent 2-70 years (inclusive)

  2. Diabetes diagnosis, based on Investigators clinical judgement, and meets thefollowing: Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - < 7years 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 theOmnipod 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 yearolds and for at least 50% of the time for 14-70 year olds for the 2 weeks precedingthe screening visit

  6. Willing to use only the following types of U-100 insulin during the study: HumalogU-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 weightloss medications that have a meaningful effect on glycemia, as determined by theinvestigator

  9. Investigator has confidence that the participant and/or caregiver can safely operateall 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/guardianwilling and able to sign the ICF. Assent will be obtained from pediatric andadolescent 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

Exclusion Criteria:

  1. Any medical condition, which in the opinion of the investigator, would put theparticipant at an unacceptable safety risk

  2. Current or known history of coronary artery disease that is not stable with medicalmanagement per investigator judgment, including unstable angina, or angina thatprevents moderate exercise despite medical management, or a history of myocardialinfarction, percutaneous coronary intervention, or coronary artery bypass graftingwithin the 12 months prior to screening

  3. Any planned surgery during the study which could be considered major in the judgmentof the investigator

  4. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is definedas an event that requires the assistance of another person due to altered mentaland/or physical status, and requires another person to actively administercarbohydrate, glucagon, or other resuscitative actions.

  5. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) inthe 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 ofsensor or pump placement

  7. Blood disorder or dyscrasia within 3 months prior to screening, which in theInvestigator'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 localsteroid injection (e.g. intraarticular, epidural) within 1 week prior to screeningor plans to take oral or injectable steroids during the study

  10. For type 1 participants only. Use of non-insulin glucose-lowering medication otherthan metformin and GLP1, in the 4 weeks prior to screening. Participants takingmetformin 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 ofbirth control (acceptable forms of contraception include abstinence, barrier methodssuch as condoms, hormonal contraceptives, intrauterine device, surgicalsterilization such as tubal ligation or hysterectomy, or vasectomized partner)

  12. In the past 30-days, has participated in a clinical study using any investigationaldrug or any investigational device. Additionally, may not intend to participate inany 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 otherwisedeemed unacceptable to participate in the study per the Investigator's clinicaljudgment

  15. Participant is an employee of Insulet, an Investigator or Investigator's study team,or immediate family member of any of the aforementioned

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Omnipod 5 SmartAdjust 2.0 System
Phase:
Study Start date:
March 26, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • University of Southern California

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Henry Ford

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • International Diabetes Center

    Minneapolis, Minnesota 55416
    United States

    Active - Recruiting

  • University Hospitals Cleveland

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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