## 3 Results
### Main Results
\begin{table}
\begin{tabular}{c c c c c c} \hline \hline  & **Time in Target Range** & **Time in Hypoglycemia** & **Time in Hyperglycemia** & **Mean Glucose Level** & **Glucose Variability** & **Insulin Units** \\  & **(70-180 mg/dL)** & & & & \\  & & FIASP + PR (CLS) vs. & FIASP + PR (CLS) vs. & FIASP + PR (CLS) vs. & FIASP + PR (CLS) vs. \\  & FIASP + PR (CLS) vs. & FIASP (CC) & FIASP (CC) & FIASP (CC) \\  & FIASP (CC) & **+70 mg/dL** & **+180 mg/dL** & FIASP + PR (CLS) vs. & **SD (mg/dL)** & **Total basal** \\  & & 0\% vs. 1.8\% & 24.3\% vs. 19.8\% & FIASP (CC) & 49 \%. 45 & 30.5\%. 30\%. \\ Toukas, (2021b) [25] & 74.3\% vs. 78.1\% & \(p=0.058\) & \(p=0.003\) & 18 \%. 142 & \(p=0.44\) & \(p=0.02\) \\  & & **+60 mg/dL** & **+224 mg/dL** & \(p=0.060\) & VCC* & **Total basal** \\  & & 0\% vs. 0\% & 2.4\% vs. 0.4\% & 31.4\%. 33.1 & 18 \%. 8\%. 27 \\  & & \(p=0.32\) & \(p=0.56\) & \(p=0.010\) \\ \hline \hline \end{tabular} Note: The results of the FASP (NA) phase in [PERSON] et al. (2021), which had worse results than the two reported interventions, are not included. SMC sample model announcement. CC: carbohydrates counting ’V’: variation coefficient; SD: standard deviation; FASP: faster-acting Insulin apart (Ultra-rapid Insulin); RAI: rapid Insulin; RICH regular Insulin; RICH regular Insulin; PL: placebo; PS: clean-loop system.  
\end{table} 
Table 3: Cont. 3.2 FiASP-and-Pramlintide System with SMA vs. FiASP System with CC vs. FiASP System with SMA Effectiveness  
* **Clinical results. ** The crossover feasibility trial (n = 7) and the pilot study (n = 4) by [PERSON] et al. (2021) [24] did not perform statistical contrasts, given the small sample sizes. According to the feasibility study, the dual system with SMA had a shorter time under 70 mg/dL than the FiASP with CC (2.1% vs. 4.1%), a slightly longer time in target range (84% vs. 81%) and less use of boluses (8.4 vs. 18.1). In the pilot study, the time in hypoglycemia was longer with the dual system (1.4% vs. 1.0%), which also used fewer boluses (13.0 vs. 18.4). This study also included a phase of FiASP alone with SMA, which obtained clearly worse results than the other two interventions (results not shown in the table). * **Quality of life. ** In the pilot study, the dual system obtained lower diabetes-related stress scores (Diabetes Distress Scale, range 1-6) than FiASP alone (1.8 vs. 2.4) but slightly worse values in fear of hypoglycemia (1.6 vs. 1.4, Hypoglycemia Fear Survey-II, range 1-5). * **Satisfaction with treatment. ** The dual system scored slightly worse than FiASP alone (4.1 vs. 4.3, INSPIRE questionnaire, range 1-5). Safety  
During the FiASP-alone phase of the feasibility study, there were no complaints of gastrointestinal symptoms after any meal, whereas with the dual system, mild symptoms occurred in 12.9% of meals, moderate symptoms in 6.5%, and moderate-severe symptoms in 6.5% (none serious). In the pilot study, the phase with the dual system had slightly higher scores in frequencies (1.3 vs. 1.1) and severity (1.3 vs. 1.0) on the Diabetes Bowel Symptom Questionnaire (range 1-5). During the pramlintide phase, two patients showed skin irritation in the area of the infusion of this hormone, and another patient showed lipopolysaccharide in the area of the infusion of both hormones. 3.3 FiASP-and-Pramlintide System with no Meal Input (Fully Artificial Pancreas) vs. FiASP-Alone System with Precise CC (Hybrid Artificial Pancreas) Effectiveness  
* **Clinical results. ** In the study by [PERSON] et al. (2021b) [25] (n = 28), the dual-release system was found to be non-inferior (within 6% of the time) to the hybrid system (without pramlintide) for time in target range (74.3% vs. 78.1%, \(p\) = 0.28). There were no significant differences in time in hypoglycemia and hyperglycemia or glycemic variability for the 24-h period in the superiority contrasts.