Type 2 Diabetes (T2D) Clinical Trials

• Age at time of consent 14-75 years (inclusive)

• Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment

• Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation

• HbA1c ≥ 7.5%

• Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user

• Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user

• Currently using a continuous glucose monitor

• 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.

• Participant agrees to provide their own insulin for the duration of the study

• Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol

• If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), 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.

• Willing to wear the system continuously throughout the study

• Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \< 18 years per local regulatory requirements

• Able to read and understand English and operate the study device in English

• If of childbearing potential, willing and able to have pregnancy testing