4. Discussion
T1DM
After calculating the maximum allowable error in CHO counting for each patient, such that it did not lead to undesirable postprandial BG fluctuations, we determined that the average value among the 33 subjects in the sample was 9.13 g. This value is in line with the findings of Smart [The experiments conducted included a control scenario and nine scenarios introducing different CC errors. A scenario was created in which patients made errors up to the maximum error of both underestimating and overestimating the amount of CHO in the meal, and the remaining scenarios were created to represent situations in which the patient’s tendency was always to underestimate or overestimate. We considered it relevant to perform polarized experiments, as some aforementioned studies [It is also important to note that CHO is not the only factor that influences postprandial glycemia, other nutrients present in the meal, such as fats and proteins, as well as previous physical activity, can affect postprandial BG. Thus, two groups of patients were defined for the analysis of results, one with TIR of 100% in the error-free experiment and another for subjects with TIR above 90%. For the group of patients always in range, we could better isolate the impact of incorrect CHO estimations. Nevertheless, having BG always in range is not the most common glycemic profile for patients with T1DM; for that reason, we analyzed the second group with TIR above 90%. This way, we intended to reproduce a more realistic scenario.The data from the two groups showed some differences. As expected, the glycemic control of the group with TIR greater than 90% deteriorated more sharply, especially in the underestimation zone experiments. This may be due to the postprandial peaks, once the calculation of the maximum error was developed to make BG on target 2–3 h after the meal and not before. In this trial, the patients used continuous glucose monitors to collect BG levels every 5 min, including the peaks logs. It is noteworthy that the goals for T1DM are far more permissive for TAR (<25% of the time) than for TBR (<4%) [To the best of our knowledge, this was the first study to utilize a patient-specific calculation to compute the maximum error in CC. The results demonstrated how the TIR, TAR, and TBR values deteriorated as the error introduced approached the limit, highlighting the last experiments (EHowever, it is necessary to note the limitations of this study. The sample used was small, with fewer than 30 subjects remaining for statistical analysis. To overcome this, the nonparametric bootstrap method was implemented. Furthermore, as mentioned in the previous section, the method used to calculate the safe interval was designed to make the postprandial glycemic on target 2–3 h after the meal, leading to an increase in the TAR and, consequently, to the worst TIR values in the scenarios where the patients underestimated CHO. To overcome this, the mathematical model could be adjusted by applying correction factors to the safe interval to compensate for the postmeal peak effect. Although the simulator is an excellent tool for an initial phase of preclinical testing, the study must be repeated in a sample of patients in a real-world context to validate the method. It may also be pertinent to carry out a differentiated analysis for the different age groups.