All participants will be free to live during the study.Each intervention phase is 12 weeks, preceded by a 2-week training period and separated by a 2-week washout period. During the training period, eligible participants will be trained to use the study rt-CGM and insulin pump and randomly assigned 1:1 to two treatment sequences after the training period. In Sequence A, patients use AndroidAPS-rt-CGM for the first intervention period (phase 1) and SAP for the second intervention period (phase 2); in Sequence B, patients use SAP for phase 1 and AndroidAPS-rt-CGM for phase 2. Participants who enter sequences A and B will be trained to use the study devices running in automated insulin delivery(AID) mode on the first day of phase 1 and phase 2, respectively. AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone. The participants will use the study patch pump and rt-CGM, but the AndroidAPS algorithm and advanced features will not be allowed during the SAP intervention period. During the washout period, participants will continue using the study insulin pump with their standard settings, but the study rt-CGM will be replaced by blood glucose meters and compatible test strips (Bayer; Bayer Consumer Care; USA).The efficacy outcomes( change in percentage of sensor glucose values below, within, and above target range; mean sensor glucose value,measures of glycemic variability and the change in centralized HbA1c) and safety outcomes(including the frequency of hypoglycemia events, diabetic ketoacidosis, and other serious adverse events) from baseline to the end of each period will be compared between AndroidAPS-rt-CGM and SAP in adult T1DM patients with suboptimal glycemic control.
This is a 26-week randomized, open-label, two-arm, two-phase, crossover trial. Participants will receive two interventions at different phases, including Android artificial pancreas system(AndroidAPS-rt-CGM) and sensor augmented pump(SAP), and use marketed rapid-acting insulin analogs (insulin Aspart, insulin Lispro, or insulin Glulisine) normally used in their usual clinical care. The safety and efficacy of AndroidAPS-rt-CGM and SAP in adult T1DM with suboptimal glycemic control will be compared to explore whether the use of AndroidAPS-rt-CGM in adult T1DM with suboptimal glycemic control will be associated with better glycemic control with no increased hypoglycemia.