Comparing two Omnipod systems for managing type 1 diabetes

Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 Diabetes

This study is testing whether the new Omnipod 5 SmartAdjust 2.0 System works better than the regular Omnipod 5 System for people with type 1 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 2 Years to 70 Years
• Sex: All
• Sponsor: Insulet Corporation (industry)
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT06865989 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, cross-over study aims to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System compared to the Omnipod 5 System in individuals with type 1 diabetes. Participants will undergo three periods of treatment, starting with one system for four weeks, switching to the other for another four weeks, and then using the SmartAdjust 2.0 System for an additional 4-6 weeks. Throughout the study, participants will be expected to manage their diabetes according to their usual routines while adhering to specific insulin usage guidelines. The study involves approximately five in-person visits to monitor progress and adherence.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 to 70 years with a diagnosis of type 1 diabetes who are current users of the Omnipod 5 system.

Not a fit: Patients who have not been using the Omnipod 5 system for at least three months prior to screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diabetes management and better health outcomes for individuals with type 1 diabetes.

How similar studies have performed: Other studies have shown success with similar insulin delivery systems, indicating a promising approach to diabetes management.

Eligibility criteria

Inclusion Criteria:

1. Age at time of consent 2-70 years (inclusive)
2. 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. Diagnosis is based on investigator's clinical judgment
3. Living with a parent or guardian if \< 18 years old
4. Current Omnipod 5 user 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. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
9. Willing to wear the system continuously throughout the study
10. 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
11. Able to read and understand English
12. 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. Any planned surgery during the study which could be considered major
3. 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.
4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion failure
5. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
6. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
7. Use of hydroxyurea
8. Use of non-insulin anti-hyperglycemic 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
9. 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)
10. 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.
11. Planned international travel during the study
12. 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
13. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Where this trial is running

Los Angeles, California and 9 other locations

• University of Southern California — Los Angeles, California, United States (NOT_YET_RECRUITING)
• Sansum Diabetes Research Institute — Santa Barbara, California, United States (RECRUITING)
• University of Colorado Denver — Aurora, Colorado, United States (RECRUITING)
• Yale University School of Medicine — New Haven, Connecticut, United States (RECRUITING)
• Northwestern University — Chicago, Illinois, United States (RECRUITING)
• Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)
• Henry Ford — Detroit, Michigan, United States (RECRUITING)
• International Diabetes Center — Minneapolis, Minnesota, United States (RECRUITING)
• University Hospitals Cleveland — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Trang Ly, MD, PhD

Conditions: Diabetes Mellitus, Type 1, T1D, Omnipod, Omnipod 5