Simplified Onboarding in Adults With Type 2 Diabetes

Launched by INSULET CORPORATION · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to start insulin treatment for adults with type 2 diabetes using a device called the Omnipod M System. This system includes a small insulin pump (the Pod), a controller to manage it, and a continuous glucose monitor (CGM) called the Dexcom G6, which tracks blood sugar levels throughout the day. The goal is to see how safe and easy it is for people to begin insulin therapy with different starting doses using this automated system.

Adults aged 18 to 75 who have had type 2 diabetes for a while and have been using insulin for at least three months may be eligible. Participants should be willing to use specific types of insulin and be comfortable wearing the pump and glucose monitor continuously during the study. The study involves an initial evaluation period lasting up to 12 weeks, followed by a main study lasting up to 6 weeks, where participants will manage their diabetes with the Omnipod M System in an automated mode. People with certain health conditions or recent use of similar insulin pump systems may not be eligible. If you join, you will need to provide your own insulin and smartphone compatible with the CGM. This study aims to help improve how insulin treatment is started and managed in people with type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age at time of consent 18-75 years
• • 2. 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)
• • 3. 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 \<12%. For basal only users must have A1c \>7% and \<12%.
• • 4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
• • 5. Participant agrees to provide their own insulin for the duration of the study
• • 6. Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
• • 7. 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
• • 8. Willing to wear the system continuously throughout the study
• • 9. Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
• • 10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
• • 11. Able to read and understand English
• • 12. Willing and able to sign the Informed Consent Form (ICF)
• • 13. If female of childbearing potential, willing and able to have pregnancy testing
• Exclusion Criteria:
• • 1. Use of an AID pump in automated mode up to 90 days prior to screening
• • 2. 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)
• • 3. 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
• • 4. 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
• • 5. Any planned surgery during the study which could be considered major in the opinion of the Investigator
• • 6. History of more than 1 severe hypoglycemic event in 6 months prior to screening
• • 7. 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
• • 8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
• • 9. Use of hydroxyurea
• • 10. 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
• • 11. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
• • 12. 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)
• • 13. Planned international travel during the study
• • 14. 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
• • 15. 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
• • 16. 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