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

Launched by INSULET CORPORATION · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the Omnipod® SmartAdjust 2.0 System to see how safe and effective it is for people with type 1 diabetes compared to the existing Omnipod® 5 System. The trial involves participants using these systems to manage their diabetes over several weeks, with everyone starting on one system and then switching to the other. Participants will meet with study staff for about five in-person visits and will be asked to follow their usual diabetes care routine, aiming to limit their meal or snack boluses to three per day during the last part of the study.

To be eligible for the trial, participants should be between 2 and 70 years old, have been diagnosed with type 1 diabetes for at least three months (longer for older participants), and currently use the Omnipod 5 system. They also need to be comfortable managing the devices and agree to provide their own insulin. The study is open to both children and adults, and parental consent is required for those under 18. Participants should expect to wear the system continuously during the study and adhere to certain guidelines regarding their diabetes management. This trial is currently recruiting participants, and it's a great opportunity for those looking to explore new options for managing their diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age at time of consent 2-70 years (inclusive)
• 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:
• • 1. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
• • 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