Next-Generation AID Algorithm for Type 1 Diabetes using Omnipod system
Official title: Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D
Run by Insulet Corporation · NCT07593625 · Data updated 2026-11-12
This study tests a new automated insulin delivery algorithm with Omnipod M/S in people with type 1 diabetes to see if it can safely support glucose control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Insulet Corporation Industry-sponsored |
| Locations | 1 site (Christchurch) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07593625 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals aged 2 to 70 with type 1 diabetes for a minimum duration, using or eligible for insulin pump therapy, and able to operate the study devices.
✕Probably not a fit
Participants not benefiting may be due to device intolerance, insufficient access to compatible insulin, or other medical factors that limit automated delivery use.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study enrolls up to 80 participants with type 1 diabetes to test the safety and practicality of the Omnipod automated insulin delivery algorithms. Participants may use multiple daily injections or an insulin pump, and will undergo hotel and outpatient evaluation periods. The study aims to have at least 48 participants start using Omnipod during the trial. It evaluates whether the Omnipod M/S system can be safely operated by a broad age range and under real-world conditions. Data collected will inform future use of automated insulin delivery in this population.
Why it matters
Potential benefit: If successful, participants could experience improved glucose control with automated insulin delivery and greater ease of management.
How similar studies have gone: Prior research in automated insulin delivery has shown promise, but this specific next-generation Omnipod algorithm is being tested for feasibility and safety in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at time of consent 2-70 years (inclusive) * Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment * Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation * Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents * Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities * If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes. * Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol * Willing to wear the system continuously throughout the study * 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 participants per local regulatory requirements * Able to read and understand English * If of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: * Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse. * Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening * Any planned surgery during the study which could be considered major in the opinion of the Investigator * History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia 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 * History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement * Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c * Use of hydroxyurea * Plans to receive blood transfusion over the course of the study * Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study * Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and/or GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose without dose increases during study participation * Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal). * In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management. Additionally, may not intend to participate in any other interventional clinical study during this study period * 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 * Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned
Where it's running
-
University of Otago
Christchurch, New Zealand Recruiting
Study contacts
- Study coordinator: Trang Ly, MBBS, PhD
- Email: APClinical@insulet.com
- Phone: 978-600-7000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.