OP5-005 Using Omnipod 5 in Adults With Type 2

This outpatient study consists of 2 phases.

Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information.

Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

Inclusion criteria

• 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 (long-acting insulin and rapid acting analog) or pre-mix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 7.0% and < 12.0%
• Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
• 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
• Stable doses of weight loss medications over the preceding 4 weeks and 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
• Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
• 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 or Spanish
• Willing and able to sign the Informed Consent Form (ICF)
• If female of childbearing potential, willing and able to have pregnancy testing

Exclusion criteria

• Use of an AID pump in automated mode within 3 months 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)
• 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 the 6 months prior to screening
• 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, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c
• Plans to receive blood transfusion over the course of the study
• Has taken oral or injectable steroids within 8 weeks 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)
• Participation in another clinical study using an investigational drug or device other than the Omnipod 5 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