Introduction Compare cost of the interstitial liquid glucose flash monitoring (FM) system (FreeStyle Libre 2) versus self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes mellitus (T1DM) in Spain. Research design and methods A model was developed to estimate, with the perspective of the Spanish health system, the annual costs associated with glucose monitoring and hypoglycemic events management in T1DM population, with multiple insulin daily doses (MDI). According to published evidence, rate of severe hypoglycemia (SHE) of 4.90 episodes per patient-year was applied. Reduction of SHE (58.6%) was modeled associated with FM use. Published rates of hospital care (20.2%) and subsequent admission (16%) were assumed for SHE. The daily consumption of strips and lancets was 9 in patients with SMBG (before and after 4 daily intakes and at bedtime) and 0.5 for FM users (according to IMPACT trial findings). Annual consumption of 26 FM sensors was considered (1 every 14 days). Unit costs (in € of 2019, excluding VAT) were obtained from literature and national databases. Sensitivity analyses (SA) were carried out to evaluate the model robustness. Results The total annual cost/patient was €4437 for SMBG and €2526 for FM. The use of FM would be associated with an annual savings in the costs of monitoring and managing hypoglycemic events of €1911 per patient-year. In a hypothetical cohort of 1000 patients with T1DM MDI, FM could avoid in 1 year 4900 SHE, 93 hospitalizations for SHE. In addition, the use of FM would generate total savings of up to €1 910 000 per year. In the SA with alternative hypoglycemia events rates and use of strips and lancets, and including non-SHE episodes, savings from €370 000 to €1 760 000 were observed with FM. Conclusions The use of the FM system to monitor glucose in adults with T1DM treated with MDI, would reduce hypoglycemic events and would result in cost savings for the health system.

https://drc.bmj.com/content/bmjdrc/8/1/e001330.full.pdf

Cost analysis of the flash monitoring system (FreeStyle Libre 2) in adults with type 1 diabetes mellitus

Background. Pharmacological non-adherence in chronic diseases is 40–65%. No predictive profile of non-adherence exists in patients with multiple chronic diseases. Our study aimed to quantify the prevalence of non-adherence to pharmacological treatment and its associated factors in patients who visit pharmacies in Spain. Methods. This observational cross-sectional study included patients with one or more chronic diseases. The variables analyzed were demographics, diseases involved, self-medication, information about disease, and lifestyle. The main variable was adherence using the Morisky–Green test. A total of 132 pharmacies collaborated, providing 6327 patients representing all Spain regions (April–December 2016). Bivariate and multivariate analyses were performed and the area under the receiver operating characteristic (ROC) curve was calculated. Results. Non-adherence was 48.4% (95% confidence interval (CI): 47.2–49.7%). The variables that reached significance in the multivariate model were: difficulty in taking medication, self-medication, desire for more information, smoking, lower physical activity, younger age and number of chronic treatments. Discrimination was satisfactory (area under the ROC curve = 70%). Our study found that 50% patients was non-adherent and we obtained a profile of variables associated with therapeutic non-adherence. Conclusions. It is cause for concern that in patients with multiple diseases and taking multiple medications, there is an association between non-adherence, self-medication and worse lifestyle.

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Factors Associated with Non-Adherence to Drugs in Patients with Chronic Diseases Who Go to Pharmacies in Spain.

The inherent feature of inseparability causes significant sufferings for the service sector. In the case of diabetes disease in healthcare, this problem is reduced by asking patients to self-monitor blood glucose at home (SMBG). Despite the task’s importance, many patients do not fully accomplish. This study investigates what factors of patients affect their adherence to SMBG and how physician consultation fosters their adherence. Empirical results show that the adherence level is driven by patients’ capability and self-efficacy, both of which are fostered by the knowledge acquired from physicians. These findings provide insights to support strategies to reduce the service inseparability.

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Enabling customer co-creation behavior at a distance: the case of patients using self-monitoring handheld devices in healthcare

In recent years, the options in treatment of diabetes mellitus type 2 have substantially expanded (currently more than 40 molecules are approved), however, the number of patients with decompensation of diabetes for the period from 2003 to 2014 remains unchanged. In clinical guidelines injecting drugs are given the «final» role as the most effective drugs. However in clinical trials injecting drugs showed a lower adherence compared to oral drugs. Currently injectable glucose lowering drugs include not only insulin but also analogues of glucagon-like peptide-1 (aGLP-1). However, majority of studies of treatment compliance in type 2 diabetes mellitus considered only insulin. Reasons of low compliance are: 1) offering comprehensive programmes for education, monitoring and patient support by primary care physicians; 2) addressing cost and availability issues; 3) prescribing current insulin, also in combination with GLP-1 agonists; 4) use of more simple and convenient devices for injecting insulin.

Injectable therapy in type 2 diabetes mellitus: strategies to improve therapeutic adherence

Studies validating indirect methods to identify nonadherence in chronic patients who visit pharmacies are lacking. The aim of this study was to validate self-reported adherence and assess the variables associated with both overestimation and underestimation of good adherence when using this method. An observational, cross-sectional study was undertaken to validate self-reported adherence in 132 community pharmacies throughout Spain in 6237 chronic patients. The Morisky-Green test was used as the validation method and through a 2 × 2 table, the validity indicators, predictive values, and likelihood ratios were calculated. To assess the variables associated with both overestimation and underestimation of good adherence, multivariate logistic regression analysis and calculation of the area under the ROC curve were used to evaluate discriminatory capacity. Sensitivity was 27.8% (95% CI: 26.2–29.4) and specificity was 93.9% (95% CI: 93.1–94.7). Discrepancy analysis obtained a significant overestimation of good adherence (p < 0.001). The factors associated with overestimating good adherence were performing a mnemonic trick (p < 0.001), not self-medicating (p < 0.001), a high level of physical activity (p < 0.001), and an older age (p = 0.014). Factors associated with underestimation were self-medication (p < 0.001), desiring more information (p < 0.001), smoking (p = 0.014), not engaging in physical activity in the low (p = 0.006) or high (p < 0.001) categories, having a younger mean age (p = 0.007), and taking two to three (p = 0.029) or four or more (p < 0.001) chronic treatments. Self-reported adherence has good specificity but poor sensitivity. The associated profiles of the discrepancies were obtained to identify both good and poor adherence.

Validation of self-reported adherence in chronic patients visiting pharmacies and factors associated with the overestimation and underestimation of good adherence.

Factors associated to adherence to blood glucose self-monitoring in patients with diabetes treated with insulin. The dapa study.

Factores asociados a la adherencia al autoanálisis de la glucemia capilar en personas con diabetes en tratamiento con insulina. Estudio dapa

BACKGROUND The diagnosis of coeliac disease (CD) in individuals that have started a gluten-free diet (GFD) without an adequate previous diagnostic work-out is a challenge. Several immunological assays such as IFN-γ ELISPOT have been developed to avoid the need of prolonged gluten challenge to induce the intestinal damage. We aimed to evaluate the diagnostic accuracy of activated gut-homing CD8+ and TCRγδ+ T cells in blood after a 3-day gluten challenge and to compare it with the performance of IFN-γ ELISPOT in a HLA-DQ2.5 subsample. METHODS A total of 22 CD patients and 48 non-CD subjects, all of them following a GFD, underwent a 3-day 10-g gluten challenge. The percentage of two T cell subsets (CD8+ CD103+ β7hi CD38+/total CD8+ and TCRγδ+ CD103+ β7hi CD38+/total TCRγδ+) in fresh peripheral blood drawn baseline and 6 days after the challenge was determined by flow cytometry. IFN-γ ELISPOT assays were also performed in HLA-DQ2.5 participants. ROC curve analysis was used to assess the diagnostic performance of the CD8+ T cell response and IFN-γ ELISPOT. RESULTS Significant differences between the percentage of the two studied subsets of CD8+ and TCRγδ+ cells at days 0 and 6 were found only when considering CD patients (p < 10-3 vs. non-CD subjects). Measuring activated CD8+ T cells provided accurate CD diagnosis with 95% specificity and 97% sensitivity, offering similar results than IFN-γ ELISPOT. CONCLUSIONS The results provide a highly accurate blood test for CD diagnosis in patients on a GFD of easy implementation in daily clinical practice.

/pdf/activated-gut-homing-cd8-t-cells-for-coeliac-disease-eg3ex03h7s.pdf

Mercedes Galindo Rubio

Papers

Factors associated to adherence to blood glucose self-monitoring in patients with diabetes treated with insulin. The dapa study.

Factores asociados a la adherencia al autoanálisis de la glucemia capilar en personas con diabetes en tratamiento con insulina. Estudio dapa

Activated gut-homing CD8+ T cells for coeliac disease diagnosis on a gluten-free diet.

Value and Use of Genetic Test of Celiac Disease