Type 2 Diabetes MellitusNCT07276776
An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes
A study testing Omnipod M system in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 6 sites in United States.
Trial summary
This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 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
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Dec 2025to 30 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at time of consent 18-75 years (inclusive)
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening
- On current insulin regimen for at least 3 months prior to screening (i.e. basal-bolus, basal insulin only or premix)
- Basal-bolus (AID or non-AID pump \& MDI) or premix users with A1C < 14% OR basal users on long or intermediate acting insulin only with A1C > 8.0% and < 14%
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev 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
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- If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) 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, including Pods, continuously throughout the study
- Willing and able to sign the Informed Consent Form (ICF)
- 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, or coronary artery bypass grafting 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 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
- History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) 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
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- 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
- 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 sterilization such as tubal ligation or hysterectomy, or vasectomized partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).
- 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
- 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
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mountain Area Health Educational Center ( MAHEC)
Asheville, North Carolina, 28803
Texas Diabetes and Endocrinology (TDE)
Austin, Texas, 78731
Joslin Diabetes
Boston, Massachusetts, 02215
Henry Ford Health
Detroit, Michigan, 48202
Disease & Glandular Disease Clinic
San Antonio, Texas, 78229
MassResearch LLC.
Waltham, Massachusetts, 02453
About this study
This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Omnipod M system
- Keywords
- Type 2 Diabetes, T2D, Omnipod 5, Automated Insulin Delivery System
- Medical subject headings
- Diabetes Mellitus, Type 2
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.
Percent of time in hypoglycemic range <70mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Percent of time in hyperglycemic range >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Secondary outcomes (12)
Mean Glucose
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time <54 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time >250mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time >300mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Percent of time between 70-180mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Average total daily insulin (TDI)
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Average TDI/kg
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Change in weight
measures change in weight
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Patient reported outcomes
Participant responses to various questionnaires related to the investigational device as well as managing diabetes
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
4-hour post prandial glycemic metrics
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline metrics to the end of the treatment period (Day45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start12 Dec 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 40 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
- NCT07276776
- Sponsor's protocol ID
- Evolution 3
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07276776
- Acronym / sponsor ID
- Evolution 3
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes, T2D, Omnipod 5, Automated Insulin Delivery System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 11 Dec 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.
This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.
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
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age at time of consent 18-75 years (inclusive)
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening
- On current insulin regimen for at least 3 months prior to screening (i.e. basal-bolus, basal insulin only or premix)
- Basal-bolus (AID or non-AID pump \& MDI) or premix users with A1C < 14% OR basal users on long or intermediate acting insulin only with A1C > 8.0% and < 14%
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents
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, or coronary artery bypass grafting 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 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
- History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
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
Percent of time in hypoglycemic range <70mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Glucose metric from study continuous glucose monitoring system
Percent of time in hyperglycemic range >180 mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Glucose metric from study continuous glucose monitoring system
12 secondary outcomes
Mean Glucose
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time <54 mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time >250mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Percentage of time >300mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Percent of time between 70-180mg/dL
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Standard Deviation
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Coefficient of Variation
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Average total daily insulin (TDI)
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Average TDI/kg
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Change in weight
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
Patient reported outcomes
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
4-hour post prandial glycemic metrics
Time frame: Comparing baseline metrics to the end of the treatment period (Day45)
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 5 May 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.
6 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 Type 2 Diabetes Mellitus, run by Insulet Corporation at 6 sites in United States.
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 12 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Percent of time in hypoglycemic range <70mg/dL (time frame: Comparing baseline metrics to the end of the treatment period (Day45)). The study lists 2 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 5 May 2026.