AIMS: The aim was to evaluate the effect of extended use of the Omnipod® 5 Automated Insulin Delivery (AID) System in adults with type 2 diabetes and suboptimal glycaemic control. MATERIALS AND METHODS: Following an 8-week single-arm, multicentre, outpatient trial of AID in adults with type 2 diabetes and baseline HbA1c � 8% ( � 64 mmol/mol), participants were given the opportunity to continue use of the AID system in a 26-week (~6 month) extension phase. The primary safety endpoints were percentage of time with sensor glucose � 250 mg/dL and < 54 mg/dL. Additional glycaemic measures, including percentage of time in range (TIR) (70-180 mg/dL) and HbA1c, were evaluated. The use of non-insulin anti-hyperglycaemic medications was permitted throughout the entire study. RESULTS: During the initial 8-week study, participants (N�=�22) achieved a decrease in percentage of time� � �250 mg/dL from 27.4% ±�21.0% to 10.5% ±�8.8% (p�<�0.0001), which further decreased to 9.7% ±�9.2% during the extension phase (p�=�0.0002 vs. standard therapy). Percentage of time�<�54 mg/dL remained low from standard therapy through extension (median [interquartile range] 0.00% [0.00%, 0.06%] vs. 0.02% [0.00%, 0.05%], p�>�0.05). HbA1c decreased by 1.6% ±�1.2% (15.5 ±�13.1 mmol/mol, p�<�0.0001) and TIR increased by 22.4% ±�19.2% (p�<�0.0001) from standard therapy through extension with no significant change in body mass index and without an observed increase in total daily insulin requirements. CONCLUSIONS: These longer-term findings of Omnipod 5 AID System use demonstrate the potential value of AID in helping people with type 2 diabetes reach glycaemic targets.
