Using the Omnipod 5 SmartAdjust 2.0 System for Diabetes Management
Safety and Effectiveness of the Omnipod® 5 SmartAdjust 2.0 System in Individuals With Type 1 and Type 2 Diabetes
This study is testing how well the Omnipod 5 SmartAdjust 2.0 System can help people aged 2-70 with type 1 or type 2 diabetes manage their condition in everyday life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 2 Years to 70 Years |
| Sex | All |
| Sponsor | Insulet Corporation Industry-sponsored |
| Locations | 2 sites (Christchurch and 1 other locations) |
| Trial ID | NCT06547918 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals aged 2-70 years with type 1 or type 2 diabetes. It is a single-arm study that will enroll up to 75 participants, ensuring a minimum of 48 participants with both types of diabetes. Participants will initially undergo 2 weeks of Standard Therapy with a Dexcom G6 before using the Omnipod system for up to six weeks, with an optional extension for an additional six months. The study aims to assess how well this system can manage diabetes in a real-world outpatient setting.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2-70 years with type 1 diabetes or aged 16-70 years with type 2 diabetes who are currently using insulin therapy.
Not a fit: Patients who do not meet the age or diabetes management criteria, or those not currently using insulin therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and user-friendly diabetes management system for patients.
How similar studies have performed: Other studies have shown promising results with similar insulin delivery systems, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Individuals must meet all the following criteria at screening to be included in the study: 1. Age at time of consent 2-70 years (inclusive) 2. Diabetes diagnosis, based on Investigator's clinical judgement, and meets the following: * Type 1 Diabetes: 2-70 years old with A1c \<11%. Diagnosed for at least 6 months for participants aged 2- \<7 years or at least 1 year for participants aged 7-70 years. OR * Type 2 Diabetes: 16-70 years old, diagnosed with T2D and on current insulin regimen for at least 3 months. Includes basal-bolus, pre-mix, or basal only users. For basal-bolus and premix users, must have A1c \< 12.0%. For basal only users must have A1c \> 7.0% and \< 12.0%. 3. Living with a parent or guardian if \< 16 years old 4. Currently using U-100 rapid-acting insulin analogs with insulin pump or basal-bolus, pre-mix, or basal only users suitable for conversion to pump therapy for at least 3 months prior to study start 5. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents 6. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 7. Stable doses over the preceding 4 weeks of other glucose-lowering medications, as determined by Investigator, including within class dose equivalent medication 8. Stable doses over the preceding 4 weeks of weight loss medications that may affect glycemic control directly and/or indirectly, as determined by 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, including Pods, continuously throughout the study 11. If female of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: Individuals who meet any of the following criteria at screening will be excluded from study participation: 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, 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 opinion of the Investigator 4. Severe retinopathy based on retinal screening performed within the last 24 months 5. 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 consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions 6. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure 7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 8. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the Investigator's opinion could interfere with determination of HbA1c 9. Plans to receive blood transfusion over the course of the study 10. Pregnant or lactating, or is a woman 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) 11. Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period 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
Christchurch and 1 other locations
- University of Otago, Christchurch — Christchurch, New Zealand (Recruiting)
- Wellington Regional Hospital — Wellington, New Zealand (Recruiting)
Study contacts
- Study coordinator: Trang Ly, MD, PhD
- Email: APClinical@insulet.com
- Phone: 978-600-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.