## 3 Results
### Main Results  
3.1 Rapid Insulin-and-Pramlintide (CC) vs. Rapid Insulin-Alone (CC) vs. Regular Insulin-and-Pramlintide (CC)  
Effectiveness  
* **Clinical results. ** In [PERSON] et al. (2020) [8], the dual system with rapid insulin was better than rapid insulin alone for time in target range (84% vs. 74%, \(p\) = 0.001), time \(>\) 180 mg/dL (12% vs. 22%, \(p\) < 0.001), average glucose (133 mg/dL vs. 144 mg/dL \(p\) = 0.001) and coefficient of variation of the glucose level (26.8% vs. 30.3%, \(p\) = 0.035). The results were only significant during the daytime period; at night, they were only significantly favorable to the intervention in terms of the standard deviation of glucose levels (36 mg/dL vs. 45 mg/dL \(p\) = 0.002). There were no significant differences in time in hypoglycemia or the number of insulin boluses. In the overnight period, the dual system with regular insulin was significantly worse than rapid insulin alone in time in target range (83% vs. 94%, \(p\) = 0.002), time \(<\) 70 mg/dL (\(<\)1% vs. \(<\)1%, \(p\) = 0.006) and \(>\)180 mg/dL (\(<\)1% vs. \(<\)1%, \(p\) = 0.013), and also for the coefficient of variation of the glucose level (24.6% vs. 15.9%, \(p\) = 0.001). During the 24 h, the dual system required more insulin boluses (25.5 vs. 22.6 units, \(p\) = 0.002) and basal insulin (27.5 vs. 23.8 units, \(p\) = 0.048). Table 3 shows the effectiveness of the included studies. Safety  
With the dual system with rapid insulin and with insulin alone, the rate of patients with at least one hypoglycemic event (\(<\)60 mg/dL) that required treatment was similar (30% vs. 32%, respectively; no statistical contrasts were performed), as well as the number of events (12 vs. 11). In the dual system with regular insulin, the results were poorer (50% of patients had 18 events). During the phase of rapid insulin alone, no patient suffered gastrointestinal adverse events, but with the dual system with rapid insulin, there were 7% mild and 11% moderate events. In the dual system phase with regular insulin, 4% had mild gastrointestinal symptoms, 12% had moderate symptoms, and 8% had moderate-severe symptoms. Figure 3: Authors’ judgments about each item. \begin{table}
\begin{tabular}{c c c c c c c c} \hline \hline  & \multicolumn{2}{c}{**Time in Target Range**} & \multicolumn{2}{c}{**Time in Hypoglycemia**} & \multicolumn{2}{c}{**Time in Hyperglycemia**} & \multicolumn{2}{c}{**Mean Glucose Level**} & \multicolumn{2}{c}{**Glucose Variability**} & \multicolumn{2}{c}{**Insulin Units**} \\  & **Q70-180 mg/dL** & & & & & & & \\ \hline RA1 + PR (CC) vs. RAI & RA1 + PR (CC) vs. RAI & RA1 + PR (CC) vs. RAI & RA1 + PR (CC) vs. RAI & RA1 + PR (CC) vs. RAI & RA1 + PR (CC) vs. RAI \\ (CC) & (CC) & (CC) & (CC) & (CC) & (CC) & (CC) \\  & 84\% vs. 74\% & **-70 mg/dL** & **-210 mg/dL** & 133 vs. 144 & **SD mg/dL** & **Total** basal \\ \(p=0.001\) & 0\% vs. 12\% & 12\% vs. 22\% & \(p=0.001\) & 36 \% vs & 15.3 vs. 15.3 \\  & \(p=0.43\) & \(p<0.001\) & \(p=0.002\) & \(p=0.79\) \\  & & +60 mg/dL & **-250 mg/dL** & **-250 mg/dL** & **-255 v. = 29.3** & **-22.6 v. = 231** \\ Haidar (2020) [8] & & 0\% vs. 0\% & 0\% vs. 0\% & 25.6 v. = 29.3 & **-22.6 v. = 23.1** \\  & & \(p=0.002\) & \(p=0.002\) & \(p=0.017\) & \(p=0.017\) & \(p=0.035\) \\  & & & & & & \\ REGI + PR (CC) vs. RAI & REGI + PR (CC) vs. RAI & REGI + PR (CC) vs. RAI & REGI + PR (CC) vs. RAI & REGI + PR (CC) vs. RAI & REGI + PR (CC) vs. RAI \\ (CC) & (CC) & (CC) & (CC) & (CC) & (CC) \\ \(p\)vs. 74\% & **-70 mg/dL** & **-180 mg/dL** & 144 vs. 144 & **(mg/dL)** & **Total** basal \\  & & & & & & \\ \(p=0.022\) & 7.3\% vs. 12\% & 24\% vs. 22\% & \(p=0.95\) & 45 \% vs. 45 & **19.4 v. = 15.3** \\  & & \(p=0.008\) & \(p=0.49\) & & \(p=0.81\) & \(p=0.016\) \\  & &