ABSTRACT
Objectives: Verifying the clinical effectiveness and the impact on quality-of-life parameters, fear of hypoglycaemia and satisfaction with the treatment obtained with a flash glucose monitoring (MFG) devices implantation program that includes a telematic and group educational intervention in adults with type 1 diabetes. Patients and Methods: Prospective quasi-experimental study, carried out during the COVID-19 pandemic period with a 9-month follow-up at the Virgen Macarena University Hospital, Sevilla. Result(s): Eighty-eight participants were included (men: 46.6%;mean age (years) 38.08, SD: 9.38);years of DM1 evolution: 18.4 (SD: 10.49);treatment with multiple doses insulin (MDI) 70.5% vs 29.5% subcutaneous insulin infusion therapy (CSII)). Baseline HbA1c was 7.74% (1.08). After the intervention, the global decrease in HbA1c was -0.45% (95% CI [-0.6, -0.25], P<.01), increasing to -1.08% in the group that started with HbA1c>=8% (P<.01). A mean decrease in the Fear of Hypoglycemia 15 (FH15) test score of -6.5 points was observed (P<.01). In the global score of the spanish version of Diabetes Quality Of Life (DQOL-s) test, the decrease was -8.44 points (P<.01). In Diabetes Treatment Satisfaction Questionnaire test (DTQ-s), global score increased in + 4 points (P<.01). Conclusion(s): The incorporation of an educational program in group and telematic format within the development of MFG devices implantation strategies is an effective option, with associated benefits in quality of life and fear of hypoglycemia in adult patients with DM1. This option can be implemented in usual clinical practice. Copyright © 2021 SEEN y SED
ABSTRACT
Background and Aims: There is still a high number of inadequately controlled T2DM patients. Therefore, it is essential to develop innovative solutions to improve patient's empowerment by increasing patient-physician communication and their selfmanagement. The aim of this study was to analyze the effect of a home digital patient empowerment tool (Figure 1), on metabolic control in T2DM patients. Methods: Multicentric, randomized prospective clinical trial including adult T2DM patients without adequate glycemic control treated according to usual clinical practice across Spain. Figure 2 summarizes the study design and study population. The primary endpoint was the comparison of the proportion of patients who did not achieve the study glycemic target (defined as HbA1c levels ≤7.5% with a reduction in HbA1c ≥0.5 from baseline) at week 24 between groups 1 and 2. It was also performed a comparison of mean HbA1c changes from baseline to week 24 between groups 1 and 2. Results: The COVID-19 pandemic led to a premature study closure since patient's enrollment and follow-up were active during the 2020 lockdown. In total, 50 patients completed week 24 visit. Figure 3 shows the main study results. 46% patients from group 1 achieved study glycemic target vs 18% in group 2 (p = 0.067), whereas the difference in the HbA1c reduction between group 1 and 2 was -0.66% (p < 0.05). Conclusions: Our results suggest the patient empowerment through a home digital tool might allow an improvement in metabolic control and consequently a more effective management of T2DM.