Type 2 Diabetes MellitusSIMPLEUSENCT07070830
Simplified Onboarding in Adults With Type 2 Diabetes
A study testing Active Comparator: Omnipod M System with lower starting dose and Active Comparator: Omnipod M System with higher starting dose in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 6 sites in United States.
Trial summary
This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor… 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?
- Active Comparator: Omnipod M System with lower starting dose and Active Comparator: Omnipod M System with higher starting dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Jul 2025to 6 Jan 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
- Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
- Basal-bolus (non-AID pump \& MDI), pre-mix, or basal only users suitable for conversion to AID pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, they must have A1c <14%. For basal only users must have A1c >7% and <14%.
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
- Participant agrees to provide their own insulin for the duration of the study
- Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
Show all 13Show fewer
- Stable doses of weight loss medications over the preceding 4 weeks, and plans to maintain throughout the study, that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator
- Willing to wear the system continuously throughout the study
- Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
- Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- Able to read and understand English
- Willing and able to sign the Informed Consent Form (ICF)
- If female of childbearing potential, willing and able to have pregnancy testing
Who cannot join
- Use of an AID pump in automated mode up to 90 days prior to screening
- Any medical condition which in the opinion of the Investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
- Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
- 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
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
- History of more than 1 severe hypoglycemic event in 6 months prior to screening
Show all 16Show fewer
- History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
- 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
- Has taken systemic steroids (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
- Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
- Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
- Planned international travel during the study
- Participation in another clinical study using an investigational drug or device other than the Omnipod in the 30 days prior to screening or intends to participate during the 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 Investigator's study team, or immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30303
University of Colorado
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
Disease & Glandular Disease Clinic
San Antonio, Texas, 78229
MassResearch LLC.
Waltham, Massachusetts, 02453
AccellaCare
Wilmington, North Carolina, 28401
About this study
Official title: Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery
This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.
There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.
An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Active Comparator: Omnipod M System with lower starting dose, Active Comparator: Omnipod M System with higher starting dose
- Keywords
- T2D, Type 2 Diabetes, Omnipod, Omnipod 5, Automated Insulin Delivery
- 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.
Active Comparator: Omnipod M System with lower starting doseDevice
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Active Comparator: Omnipod M System with higher starting doseDevice
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Omnipod M System with lower starting dose | Active comparator | Not described Receives: Device: Active Comparator: Omnipod M System with lower starting dose |
| Omnipod M System with higher starting dose | Active comparator | Not described Receives: Device: Active Comparator: Omnipod M System with higher starting dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time <70 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Secondary outcomes (8)
Percent of time in range (TIR) 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time above range (TAR) >250 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time below range (TBR) <54 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin (TDI)
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin/kg
Glucose metric from study continuous glucose monitoring system
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Perception questionnaire
Includes questions about participant's private attitudes, feelings, and behavior related to the investigational device as well as managing diabetes.
Measured: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Weight
Measures change in weight
Measured: Comparing baseline to end of continuation phase in the randomized trial.
HbA1c
Measures changes in HbA1c
Measured: Comparing baseline to end of continuation phase in the randomized trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start18 Jul 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT07070830
- Sponsor's protocol ID
- SIMPLEUSE
- Acronym
- SIMPLEUSE
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery
- ClinicalTrials.gov ID
- NCT07070830
- Acronym / sponsor ID
- SIMPLEUSE / SIMPLEUSE
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- T2D, Type 2 Diabetes, Omnipod, Omnipod 5, Automated Insulin Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 17 Jul 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 an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.
There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.
An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnipod M System with lower starting dose | Active comparator | Device: Active Comparator: Omnipod M System with lower starting dose |
| Omnipod M System with higher starting dose | Active comparator | Device: Active Comparator: Omnipod M System with higher starting dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age at time of consent 18-75 years
- Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
- Basal-bolus (non-AID pump \& MDI), pre-mix, or basal only users suitable for conversion to AID pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, they must have A1c <14%. For basal only users must have A1c >7% and <14%.
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
- Participant agrees to provide their own insulin for the duration of the study
Key exclusion criteria (16 listed)
- Use of an AID pump in automated mode up to 90 days prior to screening
- Any medical condition which in the opinion of the Investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
- Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
- 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
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
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 |
|---|---|---|
| Active Comparator: Omnipod M System with lower starting doseOmnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system | Device | Omnipod M System with lower starting dose |
| Active Comparator: Omnipod M System with higher starting doseOmnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system | Device | Omnipod M System with higher starting dose |
Primary outcome
Percent of time >180 mg/dL
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Glucose metric from study continuous glucose monitoring system
Percent of time <70 mg/dL
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Glucose metric from study continuous glucose monitoring system
8 secondary outcomes
Percent of time in range (TIR) 70-180 mg/dL
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time above range (TAR) >250 mg/dL
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time below range (TBR) <54 mg/dL
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin (TDI)
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin/kg
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Perception questionnaire
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Weight
Time frame: Comparing baseline to end of continuation phase in the randomized trial.
HbA1c
Time frame: Comparing baseline to end of continuation phase in the randomized trial.
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 30 Jan 2026.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Active Comparator: Omnipod M System with lower starting dose and Active Comparator: Omnipod M System with higher starting dose 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 13 inclusion and 16 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 30 Jan 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 >180 mg/dL (time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.). 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 30 Jan 2026.