Efficacy and Safety of the MiniMed™ Vivera™ Algorithm: Results from a First-in-Human Feasibility Trial.

MiniMed™ Vivera™ is an automated insulin delivery algorithm designed to make meal announcements optional. This first-in-human feasibility trial evaluated the efficacy and safety of the algorithm under different meal-announcement strategies. Twenty-four adults with type 1 diabetes participated in this prospective study comprising three consecutive 3-week phases: full meal announcement (FA) phase, no meal announcement (NA) phase, and announcement-at-will phase where participants could decide whether to announce each meal (AW). Continuous glucose monitoring data and safety data were assessed for each phase. The international glycemic targets regarding time in, above, and below range were achieved on average across all three meal-announcement phases. Average time in range (70-180 mg/dL) was 82.3 ± 6.60%, 73.8 ± 7.67%, and 76.7 ± 8.98% during FA, NA, and AW phase, respectively. No device-related serious adverse events were reported. In conclusion, this feasibility trial demonstrated that the Vivera algorithm was safe and efficacious in adults with type 1 diabetes, supporting further evaluation in a pivotal trial.