Faster acting insulin aspart (FiASP) vs. insulin aspart using an advanced closed-loop system in type 1 diabetes: 12-month free living study

This follow-up 12-month observational study aims to assess the performance of an advanced hybrid closed loop (A-HCL) system delivering faster-acting insulin aspart (FiAsp) versus insulin aspart for adults with type 1 diabetes under 'free-living' conditions. This follows on from a completed pilot study that evaluated the performance of the A-HCL system delivering FiAsp versus aspart during standardised meal and exercise interventions. It is evident that evaluation of investigational devices for improving glucose control under clinically rigorous conditions is likely to provide data on performance that may be unrealistic when compared to “real-life” situations. Therefore, it is important to test these devices in real-world conditions without experimental intervention from the study team. Participants who were enrolled in ACTRN12619000469112 will be eligible to participate in this study. This study will allow participants to undergo their normal daily activities whilst utilising the A-HCL pump. Pump settings will be adjusted as per usual clinical care by the study team. Participants will be free to utilize insulin aspart or FiAsp with the pump based upon their personal preference. Participants will upload their pump regularly to allow the study team to monitor the safety of the device. Twelve participants are planned to undertake the study at one clinical site. All procedures involving study participants will be undertaken by study doctors and research nurses. Participants will receive regular text message and phone call reminders during each stage of the study to ensure adherence.