OPAL study - User Experience with Tubeless Automated Insulin Delivery System (Omnipod 5)

The intervention arm will receive an Omnipod 5 device for use during the 6-month study period. The Omnipod 5 consists of a pod unit with a reservoir of insulin inside, that has a cannula inserted subcutaneously in the user, and sits on top of the insertion site with an adhesive patch. An external controller device acts as the interface for manual bolus insulin infusion and for changing insulin delivery settings. The pump forms an Automated Insulin Delivery (AID) system by integrating with a Dexcom G6/G7 continuous glucose monitor (CGM), providing real-time changes to insulin delivery magnitude and frequency. The Omnipod 5 tubeless insulin pump is approved for use for people with Type 1 diabetes aged 2 and above in Australia through the Australian Therapeutic Goods Administration (ARTG ID 455009). The pump is accessible to families via private health insurance or self-funding, but will be provided to participants through the study. Participants will be asked to complete a series of questionnaires at baseline, mid-point (12 weeks) and end-of-study (24 weeks), assessing their experience with the Omnipod 5 insulin pump. Participants (and their families, if under the age of 18) receiving an Omnipod 5 will undergo training for insulin pump starts and the use of AID, to be conducted on site at Perth Children's Hospital Outpatient D research clinic by a diabetes educator within the study team. The diabetes educator will also review the participant's CGM data at each study visit to ensure the participant's safety and study compliance (i.e. CGM use greater than or equal to 70% of the time). At the end of the study period, participants may be approached to share their experiences through a semi-structured interview.