Type 1 DiabetesEVOLUTIONT1DNCT07593625
Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D
A study testing Omnipod M System and Omnipod S in people with Type 1 Diabetes and Type 1 Diabetes Mellitus, run by Insulet Corporation at 1 site in New Zealand.
Trial summary
Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods. Read more about this study
- Who is it for?
- Ages 2 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes (DM)
- What is being tested?
- Omnipod M System and Omnipod S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNew Zealand
- Study dates
- 25 May 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
University of Otago
Christchurch, 8140
Mercedes Burnside, MD, mercedes@edgetrials.co.nz
Martin deBock, FRACP, PHD
About this study
Official title: Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D
Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.
- Conditions
- Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes (DM)
- Being tested
- Omnipod M System, Omnipod S
- Keywords
- Type 1 Diabetes, T1D, Omnipod, Omnipod M, Automated Insulin Delivery System, AID, fully closed loop, FCL, Omnipod S, Bolus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod M SystemDevice
Participants will use the Omnipod M System
Omnipod SDevice
Participants will use the Omnipod S System
| Study group | Role | What they receive |
|---|---|---|
| Adults with T1D using Omnipod M | Experimental | Not described Receives: Device: Omnipod M System |
| Adults and pediatrics with T1D using Omnipod S | Experimental | Not described Receives: Device: Omnipod S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time <54 mg/dL
CGM percent time <54 mg/dL compared to standard therapy
Measured: 72-hour Omnipod M Hotel Period
Percentage of time <70 mg/dL
CGM percent time <70 mg/dL compared to standard therapy
Measured: 72-hour Omnipod M Hotel Period
Percentage of time >180 mg/dL
CGM percent time >180 mg/dL compared to standard therapy
Measured: 72-hour Omnipod M Hotel Period
Percentage of time <54 mg/dL
CGM percent time <54 mg/dL compared to standard therapy
Measured: 4-week Omnipod M outpatient
Percentage of time <54 mg/dL
CGM percent time <54 mg/dL compared to initial data collection phase
Measured: Final 3 weeks of Omnipod S outpatient
Percentage of time <70 mg/dL
CGM percent time <70 mg/dL compared to standard therapy
Measured: 4-week Omnipod M outpatient
Percentage of time <70 mg/dL
CGM percent time <70 mg/dL compared to initial data collection phase
Measured: Final 3-weeks Omnipod S outpatient
Percentage of time >180 mg/dL
CGM percent time >180 mg/dL compared to standard therapy
Measured: 4-week Omnipod M outpatient
Percentage of time >180 mg/dL
CGM percent time >180 mg/dL compared to initial data collection phase
Measured: Final 3-weeks Omnipod S outpatient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start25 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593625
- Sponsor's protocol ID
- EVOLUTION T1D
- Acronym
- EVOLUTIONT1D
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D
- ClinicalTrials.gov ID
- NCT07593625
- Acronym / sponsor ID
- EVOLUTIONT1D / EVOLUTION T1D
- Conditions
- Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes (DM)
- Keywords
- Type 1 Diabetes, T1D, Omnipod, Omnipod M, Automated Insulin Delivery System, AID, fully closed loop, FCL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with T1D using Omnipod M | Experimental | Device: Omnipod M System |
| Adults and pediatrics with T1D using Omnipod S | Experimental | Device: Omnipod S |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod M SystemParticipants will use the Omnipod M System | Device | Adults with T1D using Omnipod M |
| Omnipod SParticipants will use the Omnipod S System | Device | Adults and pediatrics with T1D using Omnipod S |
Primary outcome
Percentage of time <54 mg/dL
Time frame: 72-hour Omnipod M Hotel Period
CGM percent time <54 mg/dL compared to standard therapy
Percentage of time <70 mg/dL
Time frame: 72-hour Omnipod M Hotel Period
CGM percent time <70 mg/dL compared to standard therapy
Percentage of time >180 mg/dL
Time frame: 72-hour Omnipod M Hotel Period
CGM percent time >180 mg/dL compared to standard therapy
Percentage of time <54 mg/dL
Time frame: 4-week Omnipod M outpatient
CGM percent time <54 mg/dL compared to standard therapy
Percentage of time <54 mg/dL
Time frame: Final 3 weeks of Omnipod S outpatient
CGM percent time <54 mg/dL compared to initial data collection phase
Percentage of time <70 mg/dL
Time frame: 4-week Omnipod M outpatient
CGM percent time <70 mg/dL compared to standard therapy
Percentage of time <70 mg/dL
Time frame: Final 3-weeks Omnipod S outpatient
CGM percent time <70 mg/dL compared to initial data collection phase
Percentage of time >180 mg/dL
Time frame: 4-week Omnipod M outpatient
CGM percent time >180 mg/dL compared to standard therapy
Percentage of time >180 mg/dL
Time frame: Final 3-weeks Omnipod S outpatient
CGM percent time >180 mg/dL compared to initial data collection phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipod M System and Omnipod S in people with Type 1 Diabetes and Type 1 Diabetes Mellitus, run by Insulet Corporation at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trang Ly, MBBS, PhD (978-600-7000, APClinical@insulet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time <54 mg/dL (time frame: 72-hour Omnipod M Hotel Period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.