Novel fully automated fiasp-plus-pramlintide artificial pancreas for type 1 diabetes: randomised controlled trial

We aimed to assess a novel fully automated fiasp-plus-pramlintide artificial pancreas. We conducted a randomized crossover noninferiority trial comparing (i) a fully automated fiasp-and-pramlintide artificial pancreas and (ii) fiasp-alone artificial pancreas with carbohydrate counting, in 23 adults with type 1 diabetes (age 35±15 years, HbA1c 8.1±1.4 per cent [%]). Fiasp and pramlintide were delivered using a novel dosing algorithm at a fixed ratio (10 micrograms per unit [μg/u]) with a meal detection to trigger boluses. Each participant completed two 27-hour inpatient interventions. The primary outcome was time spent in target range (3.9–10.0 millimoles per liter [mmol/L]) during a 24-hour period. The fully automated system achieved similar time in target (71%) compared to fiasp-alone hybrid system (75%, p=0.47), but with less time <3.9 mmol/L (median 0%, 1.4%; p=0.039). The fully automated system achieved comparable time >10 mmol/L (27%, 22%; p=0.29), >13.9 mmol/L (6.5%, 5.7%; p=0.80) and >16.7 mmol/L (1.8%, 2.3% respectively; p=0.81). Nonmild gastrointestinal symptoms were reported by 3 participants (13%) with the fully automated system compared to 0 with the fiasp-alone system. Our novel fiasp-and-pramlintide system is fully automated and noninferior to the fiasp-alone hybrid system.