After performing the pharmacotherapeutic follow-up, in the context of judicialization it was possible to observe a significant improvement in the glycemic levels of patients with T1DM, as demonstrated in studies carried out with patients with diabetes mellitus type 2 (T2DM) [12]. In the present study, the intervention provided a 0.5% reduction in the mean value of HbA1c. This result reinforces the importance of pharmacotherapeutic follow-up in patients with DM, since the control of HbA1c levels in these patients has an impact on the prevention of clinical complications. The literature explains that every 1% reduction in HbA1c reduces the risk of amputations by 43%, the risk of microvascular complications by 37% and the risk of acute myocardial infarction by 14% [28].
As a consequence of the reduction in clinical complications, the decrease in HbA1c levels also has the potential to generate cost savings. As noted by Wagner et al. (2001), a 1% reduction in HbA1c can save $685.00 to $950.00 per patient per year [29]. Following this logic, with the results obtained in the present study, savings of $342.50 to $475.0 per patient per year could be generated. It is important to consider that the cost of care related to DM corresponds to about two to three times more when compared to patients who do not have the disease [30] and that patients with poor glycemic control generate significantly higher expenses than patients with adequate blood glucose levels [31]. Additionally, special attention should be paid to the large number of lawsuits regarding the treatment of these patients, especially insulin analogues [32]. Thus, it can be said that the implementation of the pharmacotherapeutic follow-up service can contribute to the rationalization of the judicialization of health.
In addition to glycemic control, pharmacotherapeutic follow-up significantly impacted SBP. However, the reduction in DBP was not statistically significant, similar to other studies analyzed [33]. A significant reduction in SBP was also observed in a study conducted by Santschi et al. (2014). In this meta-analysis comprising 39 randomized clinical trials, pharmaceutical interventions were associated with a reduction in SBP and DBP of −7.6 mmHg (95%CI: −9.0; −6.3) and −3.9 mmHg (95%CI: −5.1; −2.8), respectively [34]. According to Korcegez et al. (2017) these outcomes may have resulted from diabetes education, and above all, from the improvement of health behaviors, adherence, and pharmacotherapy management arising from pharmacotherapeutic follow-up [35].
After the intervention, a significant increase in BMI was observed, suggesting that patients with T1DM, in an attempt to optimize their insulin treatment, may experience weight gain. This can be explained by the fact that insulin participates in the regulation of lipogenesis and basal metabolism, in addition to inhibiting protein catabolism [36]. The risk of weight gain has been previously reported in patients with DM [37]. A study carried out in the United States in 2013 showed that young people with T1DM, followed for 24 months, had weight gain associated with the concomitant achievement of glycemic control, which can be partially explained by the increase in insulin administration [38]. In contrast, in a study conducted by Lipsky et al. (2016), young people with T1DM followed for 18 months did not have BMI associated with glycemic control [39].
A 2011 prospective clinical trial conducted in DM patients in a city in the state of São Paulo showed that significant reductions in BMI (-0.1 kg/m2; p<0.001) and WC (-0.6 cm ; p<0.001), over 36 months of follow-up, were observed in the group that received intervention from the clinical pharmacist, associated with reductions in the mean values of fasting glucose (-27.2 mg/dL; p<0.001) and HbA1c (-0.7% p<0.001). However, the study population was not exclusively composed of patients with T1DM, and thus the frequency of insulin use (10.3%) was lower than the other studies presented here [40].
Even in light of scientific evidence, we need to consider that the variability found in relation to weight gain can be attributed to different lengths of time in the follow-up and clinical characteristics of the study participants. Altogether, it is necessary to emphasize that in the present study, the adiposity measurement was based almost exclusively on the BMI and WC (with a non-significant reduction). In this sense, the association between improved glycemic control versus BMI can be explained differently, since it is an imprecise measure [41] that may not truly represent the distribution of body fat of the participants in this study.
In addition to the effects found in laboratory and clinical parameters, there was an increase in patients' knowledge and skills regarding insulin application techniques after the intervention. These data are consistent with those obtained in the study by Batista et al. (2013), in which most patients did not have the knowledge and skills necessary for the correct use of insulin, which were obtained from the health education process [24]. Through these data one can see the importance of following-up the correct use of medications, since according to Flora and Gameiro (2016), patients with T1DM have difficulties in administering insulin, especially with regard to the adjustment of doses [42]. Thus, obtaining knowledge and skills related to administration techniques can contribute to the reduction of PP related to these medications.
Following this premise, the findings of this study show the importance of pharmacists for the optimization of therapy, since pharmacotherapeutic follow-up significantly reduced the amount of PP. The results corroborate the findings of a 2018 cohort in Indonesia, in which the authors found that the incidences of PP in the management of T2DM with pharmaceutical intervention were significantly reduced compared to usual care [43]. A pharmaceutical intervention study conducted by Aquino et al. (2019) showed a resolution of 60.9% of the baseline PP [12]; another study by Chung et al. (2018) also found positive results regarding the reduction of PP after pharmaceutical intervention [44].
In the present study, the identification of gaps in the pharmacotherapy of patients, such as the untreated health condition, generated referrals to the prescriber, which may have driven the significant increase in the amount of medications (p=0.046). A study carried out by Pepe et al. (2018) demonstrated that 77% of the total pharmaceutical interventions were conducted to initiate the use of a new medication [45]. According to Houle et al. (2012) new interventions have the potential to influence the increase in resource consumption and even raise costs [46]. Therefore, we believe that this result can be attributed to the consequent resoluteness of the intervened PP.
In addition to pharmacological treatment, pharmacotherapeutic follow-up also provided positive results in the non-pharmacological treatment of DM. According to Peres et al. (2019) patients with T1DM often do not follow dietary and exercise recommendations. This leads to glycemic imbalances, which culminate in the need for complex therapeutic regimens [47]. A large number of participants in this study did not follow an adequate diet and did not practice physical exercise. After the pharmacotherapeutic follow-up, an improvement in feeding was observed, elucidating that it can contribute not only to the optimization of pharmacotherapy, but also to aspects of LM associated with the disease. A review study conducted with patients with DM found that changes in the patients' lifestyle had benefits for glycemic control in a similar way to the use of medications [48]. The lack of statistical significance for the increased practice of physical exercise can be explained by the occurrence of the pandemic generated by COVID-19, which triggered a period of social distancing with the closing and restriction of clubs, public spaces, and gymnasiums.
The previously discussed results corroborate the improvement in the quality of life and health of the participants. By promoting a reduction of blood glucose levels, SBP, improvements in diet, medication consumption (observed by the resolution of PP) and in knowledge and skills in relation to insulin application techniques, there is as a consequence, an improvement in health and quality of life. In this context, the importance of the clinical pharmacist in the care of patients with DM is highlighted. According to Coradi et al. (2020) and Rahmathullah (2020), pharmacotherapeutic follow-up provides improvements in blood glucose levels, adherence to pharmacotherapy, correct and rational use of medications, knowledge about the disease, as well as promoting a better quality of life for patients, and generates cost savings for health services [49].
Regarding the sociodemographic profile, most patients are female and young individuals. These data were as expected, as women are usually more concerned about their health than men and T1DM affects younger individuals [1]. As demonstrated in previous studies referring to the judicilization of health, the insulin analogues aspart and glargine were the most used by the patients analyzed [20]. The most prevalent diseases associated with T1DM were dyslipidemia, SAH, and hypothyroidism. These results corroborate those obtained by Peres et al. (2019) in a study conducted in patients with T1DM, in which the main diseases presented were SAH, dyslipidemia and thyroid disorders, respectively, and by Coradi et al. (2020) who found SAH and dyslipidemia as the main comorbidities in patients with T2DM [50].
The present work has some limitations. The number of participants was reduced due to patients' refusal, and loss of follow-up, which could lead to a selection bias, with a different profile of participants from those who did not accept to participate or who left in the middle of the study. In addition, there is the possibility of an information bias due to the fact that data collection instruments depend on patients' self-reports. Additionally, the pandemic caused by COVID-19 did not allow the last consultation of all patients to be carried out in person. However, this is the first known study to assess the effectiveness of pharmacotherapeutic follow-up in T1DM patients receiving insulin analogues through the judicialization of health. With the results obtained, implementation strategies for pharmacotherapeutic follow-up can be structured within the scope of judicialization, with the aim of promoting benefits for patients, as well as generating cost reductions for the health system.