Safety and efficacy of the Android Artificial System (AAPS) with advanced bolus-free features in Adults with Type 1 diabetes with extended use.(Close It Extended)

The CLOSE IT randomised controlled trial demonstrated the benefits of using AAPS as a fully closed loop system compared to a hybrid closed loop system over 12 weeks. However, the short study duration limits generalizability to real-world long-term use. There is a need for longer-term evaluation to determine if the benefits of fully closed-loop delivery with AAPS are sustained with prolonged everyday use over 12 months. Understanding long-term patient experiences and perspectives will help guide education and optimisation of closed-loop systems. To determine if the efficacy of AAPS used as a fully automated closed-loop system is sustained over 12 months of real-world use in adults with type 1 diabetes. To assess the impact of prolonged fully closed loop use on glycaemic control, hypoglycaemia, hyperglycaemia, glucose variability, treatment satisfaction, quality of life, and adverse events. Intervention: Android Artificial Pancreas System (AAPS) AndroidAPS consists of three main components which all participants will have been using in the 12 weeks prior to this extension study 1. Dexcom G6® CGM: includes a glucose sensor and transmitter attached to the user with the ability to measure interstitial fluid glucose continuously. The CGM data are transferred via Bluetooth to the Dexcom G6® mobile App (an application on the study Android phone). The App can display real-time glucose data. 2. Upgraded YpsoPump®: An upgraded version of YpsoPump® with bidirectional communication capability will be developed for this study to enable communication with the AndroidAPS interface. The YpsoPump has been approved and is currently being used in Australia. (Participants are currently using these pumps in the original study) 3. Lotus: an application on the study Android phone that contains the controller algorithm. It receives real-time CGM data from the Dexcom G6® mobile App and controls the basal insulin delivery by sending commands to YpsoPump®. The basal insulin delivery rate is adjusted every 5 minutes based on varying glucose levels. This 12-month observational extension of CLOSE IT will enroll all willing participants from the original RCT to continue using AAPS as FCL with remote optimisation and comprehensive outcome assessment. Participants will use the rapid-acting analogue insulin NovoRapid®, or ultra-fast acting insulin Fiasp® throughout the duration of this trial. The primary objective is to evaluate time in range over 12 months. Secondary aims include assessing glycaemic variability, hypoglycaemia, hyperglycaemia, HbA1c, treatment satisfaction, quality of life, system performance metrics, adverse events, and perspectives from questionnaires. Overall, findings from this 12-month observational extension will determine if the feasibility and efficacy of AAPS as FCL is sustained with prolonged use and provide essential patient-centered insights to inform the development and implementation of fully automated closed-loop systems in real-world clinical care. The intervention is that all participants will be in Fully Closed Loop (FCL) mode and able to use Novorapid or Fiasp in their Ypsomed pump. The previous study had one arm in Hybrid Closed Loop (announcing meal boluses) and another arm in FCL. (not announcing meal boluses). Participants have to use AndrioidAPS, 24 hours per day, for a 12 month period Participants will be using the modified Ypsomed pump given to them in the previous study ACTRn12622001401741 and the same Android study phone. The amount of insulin administered daily, is determined by the Algorithm in the Lotus App. This takes into account Participants Basal rates over 24 hours, Insulin sensitivity, active insulin time and target BGL., Carbohydrate ratio which were originally worked out by the Diabetes Educator in previous study. They can be adjusted by physicians. The algorithm makes decisions every 5 minutes to deliver very small micro boluses to keep participants close to their target Blood Glucose Level (BGL). It will also stop delivering if the BGL is too low and resume again when BGL is in the normal range 3.9mmol/L-10mmol/L. All participants have a Night Scout site which all data is uploaded to in real time from the participants use of this system. The study staff can look at these sites at any time and they can access reports from here. The sites are de identified with participants study numbers and unique passwords. There will be 5 visits - one at the start of the study and one at the end of each 3-month period over the 12 months participants are involved. At each visit participants will have 5 mls of blood drawn for HBA1C levels, weight measurement, questionnaires to complete, and review of night scout reports (from AAPS) with study physician. To monitor or assess adherence to the intervention Study staff will send reminders via phone calls, text messages, or emails to prompt participants to adhere to the intervention protocol. visits.