Diabetes MellitusNCT07039981
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes
A study testing Omnipod M system in people with Diabetes Mellitus, run by Insulet Corporation at 2 sites in New Zealand.
Trial summary
The purpose of the study is to assess the safety and efficacy of a next generation automated insulin delivery algorithm in adults with type 2 diabetes aged 16-70 years old Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Omnipod M system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 1 Jul 2025to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent aged 16-70 years (inclusive)
- Type 2 Diabetes diagnosis based on Investigator's clinical judgement and meets the following:
- Currently using U-100 rapid-acting insulin analogs with insulin pump OR
- Basal-bolus, pre-mix, or basal only users and suitable for conversion to pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, must have A1c < 12%. For basal only users must have A1c ≥ 7% and < 12.0%.
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
- Stable doses over the preceding 30 days of other glucose-lowering medications as determined by Investigator
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- Willing to use a Dexcom CGM for the duration of the study
- Willing to use the investigational system(s) during the study
- Willing to perform all fingerstick BG testing with their personal blood glucose meter at the frequency specified in the study protocol or per investigator discretion
- Willing to receive real-time glucose alerts
- Willing and able to sign the Informed Consent Form (ICF).
Who cannot join
- Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable 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 previous 12 months), unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk.
- Blood disorder or dyscrasia within 3 months prior to screening, including the use of hydroxyurea, which in the investigator's opinion could interfere with determination of A1c.
- History of severe hypoglycaemia within the past 6 months
- History of diabetic ketoacidosis or hyperglycaemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure.
- History of severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
- Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
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- Planning to start a weight-loss agent during the study. If on a weight-loss medication, dose must be stable in the previous 30 days.
- Pregnant, or is 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 sterilisation such as tubal ligation or hysterectomy, or vasectomised partner)
- Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor.
- Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
- Currently participating in another clinical study using an investigational drug or device except for the SmartAdjust 2.0 Feasibility Study (Protocol #2024 FULL 20405)
- Recent (within the preceding 30 days) participation in a clinical study using an investigational drug, excluding Omnipod device studies.
- Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
University of Otago, Christchurch
Christchurch, 8011
Wellington Regional Hospital
Wellington, 6021
About this study
The purpose of the study is to assess the safety and efficacy of a next generation automated insulin delivery algorithm in adults with type 2 diabetes aged 16-70 years old
Read the detailed description
This study is a single-arm, multi-center, interventional clinical study that will enroll a maximum of 48 adult participants with a goal of 24 initiating the use of the Omnipod M System.
It will consist of two phases, Phase 1 will include 2-weeks of Standard Therapy followed by at least 2-weeks of SmartAdjust 2.0 System use.
In Phase 2, participants will begin use on the Omnipod M System where multiple iterations of the next-generation algorithm may be tested as needed to optimize algorithm safety and efficacy.
Participants aged 16-70 years (inclusive) with type 2 diabetes who participated in the Insulet sponsored SmartAdjust 2.0 Feasibility Study (protocol reference #2024 FULL 20405) or new participants who are currently using an insulin pump or basal-bolus, pre-mix, or basal only users will be recruited for the study.
- Conditions
- Diabetes Mellitus
- Being tested
- Omnipod M system
- Keywords
- Omnipod, Type 2 Diabetes T2D
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod M systemDevice
The Omnipod M system will allow user to use a lower glucose target and improve systems glucose control
| Study group | Role | What they receive |
|---|---|---|
| Experimental- Participants with Type 2 diabetes | Experimental | Not described Receives: Device: Omnipod M system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in hypoglycaemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Glucose metric from study provided continuous glucose monitor (CGM)
Measured: Between Day1 and Day 56
Percentage of time in hyperglycaemic range (defined as > 10.0 mmol/L (180 mg/dL))
Glucose metric from study provided continuous glucose monitor (CGM)
Measured: Between Day1 and Day 56
Incidence rate of hyperosmolar hyperglycaemic state (HHS) and/or diabetic ketoacidosis (DKA) (events per person months)
Measure of insulin requirements
Measured: Between Day1 and Day 56
Incidence rate of severe hypoglycaemia (SH) (events per person months)
Measure of insulin requirements
Measured: Between Day1 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039981
- Sponsor's protocol ID
- Evolution2
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07039981
- Acronym / sponsor ID
- Evolution2
- Conditions
- Diabetes Mellitus
- Keywords
- Omnipod, Type 2 Diabetes T2D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 26 Jun 2025 (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.
The purpose of the study is to assess the safety and efficacy of a next generation automated insulin delivery algorithm in adults with type 2 diabetes aged 16-70 years old
Detailed description
This study is a single-arm, multi-center, interventional clinical study that will enroll a maximum of 48 adult participants with a goal of 24 initiating the use of the Omnipod M System.
It will consist of two phases, Phase 1 will include 2-weeks of Standard Therapy followed by at least 2-weeks of SmartAdjust 2.0 System use.
In Phase 2, participants will begin use on the Omnipod M System where multiple iterations of the next-generation algorithm may be tested as needed to optimize algorithm safety and efficacy.
Participants aged 16-70 years (inclusive) with type 2 diabetes who participated in the Insulet sponsored SmartAdjust 2.0 Feasibility Study (protocol reference #2024 FULL 20405) or new participants who are currently using an insulin pump or basal-bolus, pre-mix, or basal only users will be recruited for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental- Participants with Type 2 diabetes | Experimental | Device: Omnipod M system |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age at time of consent aged 16-70 years (inclusive)
- Type 2 Diabetes diagnosis based on Investigator's clinical judgement and meets the following:
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
- Stable doses over the preceding 30 days of other glucose-lowering medications as determined by Investigator
- Willing to use a Dexcom CGM for the duration of the study
Key exclusion criteria (13 listed)
- Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable 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 previous 12 months), unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk.
- Blood disorder or dyscrasia within 3 months prior to screening, including the use of hydroxyurea, which in the investigator's opinion could interfere with determination of A1c.
- History of severe hypoglycaemia within the past 6 months
- History of diabetic ketoacidosis or hyperglycaemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure.
- History of severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
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 systemThe Omnipod M system will allow user to use a lower glucose target and improve systems glucose control | Device | Experimental- Participants with Type 2 diabetes |
Primary outcome
Percentage of time in hypoglycaemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Time frame: Between Day1 and Day 56
Glucose metric from study provided continuous glucose monitor (CGM)
Percentage of time in hyperglycaemic range (defined as > 10.0 mmol/L (180 mg/dL))
Time frame: Between Day1 and Day 56
Glucose metric from study provided continuous glucose monitor (CGM)
Incidence rate of hyperosmolar hyperglycaemic state (HHS) and/or diabetic ketoacidosis (DKA) (events per person months)
Time frame: Between Day1 and Day 56
Measure of insulin requirements
Incidence rate of severe hypoglycaemia (SH) (events per person months)
Time frame: Between Day1 and Day 56
Measure of insulin requirements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 in people with Diabetes Mellitus, run by Insulet Corporation at 2 sites 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 13 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: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in hypoglycaemic range (defined as < 3.9 mmol/L (<70 mg/dL)) (time frame: Between Day1 and Day 56). The study lists 4 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 1 Jun 2026.