Carmen Quirós

Análisis psicométrico de las versiones en lengua castellana y catalana de un cuestionario de percepción de la hipoglucemia

BACKGROUND AND OBJECTIVE Intensive insulin therapy with multiple insulin doses in subjects with type 1 diabetes mellitus (T1D) is associated with a higher risk of hypoglycaemic episodes. Repeated hypoglycemia results in a reduced ability/failure to recognize hypoglycemia symptoms and predisposes to severe episodes. In this context is crucial to work with specific questionnaires to diagnose and address this burden. Our study aimed to perform the psychometric analysis of Spanish and Catalan versions of Clarke et al. questionnaire for hypoglycemia awareness. PATIENTS AND METHOD Psychometric analysis in patients with T1D of Spanish and Catalan versions of Clarke et al. questionnaire in 3 phases: 1) translation, back-translation and cultural adaptation of the English version; 2) analysis of internal, external and test-retest validity, and 3) assessing sensitivity to change in hypoglycemia perception. RESULTS One-hundred and forty-four subjects with T1D answered the Clarke et al. questionnaire (mean age [SD] 36 [18] years, 46% men). We observed a Cronbach α coefficient for internal validity of 0.75, a correlation coefficient for test-retest reliability of r=0.81 and a correlation of the questionnaire score with the frequency of severe and no severe hypoglycemia events of r=0.47 and r=0.77, respectively. The analysis of 20 patients with T1D 24 months after the initiation of continuous subcutaneous insulin infusion showed a decrease in the frequency of non-severe hypoglycemia/week (from 5.40 [2.09] to 2.75 [1.74]) and in the number of severe hypoglycemic episodes/year (1.25 [0.44] to 0.05 [0.22]). This was associated with a decrease in scores of the translated versions of Clarke et al. questionnaire (from 5.45 [1.19] to 1.60 [2.03]). CONCLUSIONS Spanish and Catalan versions of Clarke et al. questionnaire display good psychometric properties and both could be considered a useful tool for evaluating hypoglycemia awareness in patients with T1D from our area.

Effect of cross-sex hormone treatment on cardiovascular risk factors in transsexual individuals. Experience in a specialized unit in Catalonia

BACKGROUND AND AIMS Since the onset of cross hormone therapy (CHT) in transsexual individuals, there has been concern about possible chronic side effects. Our objective was to assess baseline differences in lipid profile in individuals with gender identity disorder in relation to prior CHT, and changes in the lipid profile and other cardiovascular (CV) risk factors after 24 months of treatment. METHODS Retrospective longitudinal study including all individuals assisted for the first time in the Gender Identity Unit of Catalonia from 2006 to 2010. Socio-demographical, anthropometric and laboratory data were collected. RESULTS We evaluated 247 transsexuals, 150 male to female (MtF: 60.7%) and 97 female to male (FtM; 39.3%). At baseline, FtM transsexuals were younger and had started prior CHT less often than MtF (13.4% vs. 64.7%; p<0.001). During follow up, in MtF weight and BMI increased significantly, as well as systolic and diastolic blood pressure, though these latter remained within normal range. No significant differences in lipid profile were observed. FtM transsexuals also presented an increase in weight and BMI, without differences in blood pressure. A general worsening in lipid profile was observed in this group, with increased total cholesterol (166.0 ± 35.1 vs. 175.6 ± 38.2mg/dL; p=0.001), triglycerides (70.6 ± 30.7 vs. 102.3 ± 68.5 mg/dL; p<0.001) and LDL cholesterol (103.8 ± 28.7 vs. 112.8 ± 30.3 mg/dL; p=.013) and decreased HDL cholesterol (52.2 ± 12.2 vs. 45.4 ± 13.8 mg/dL; p=0.001), even though final levels were all within normal range. CONCLUSION There is no detectable increase in CV risk factors in MtF transsexuals who were treated with currently prescribed estrogenic compounds, while a slight worsening in lipid profile takes place in the FtM group, though within normal limits.

Impaired awareness of hypoglycaemia in subjects with type 1 diabetes. Results of an online survey in a diabetes web site.

OBJECTIVE To assess the frequency of impaired awareness of hypoglycaemia (IAH) using a specific questionnaire (Spanish version) in a free access diabetes-related web site. METHODS Data from a free access Spanish version of the Clarke test previously uploaded to the website of the Fundación para la Diabetes (March 2014-January 2015) were assessed. In addition to the eight questions in Clarkes questionnaire, information on type of diabetes, age, and disease duration was obtained. The Clarke test divided participants into three categories: normal awareness, uncertain and IAH. RESULTS Of the 418 participants with type 1 diabetes, 51.2% were aged 36-55 years. In 34.7%, diabetes had been diagnosed >15 years before, while disease duration was <2 years in 11%. According to Clarke categories, 23.4% had IAH, 15.3% uncertain awareness, and 61.3% normal awareness. The longer the duration of diabetes, the higher the Clarke test score. According to the Clarke test, 14.1% of participants had experienced at least one episode of severe hypoglycaemia in the previous year, and half of these (7.4%) had suffered severe hypoglycaemia two or more times. All but one of the participants with two or more episodes of severe hypoglycaemia had IAH. CONCLUSIONS Our study shows that the rate of IAH using an online survey is similar (25%) to that previously reported in other geographical areas, increases with diabetes duration, and identifies subjects prone to severe hypoglycaemia.

Evaluación de la utilización de las prestaciones específicas de los sistemas de infusión subcutánea de insulina y su relación con el control metabólico en pacientes con diabetes tipo 1

BACKGROUND AND OBJECTIVE Patients with type 1 diabetes (T1DM) treated with continuous subcutaneous insulin infusion (CSII) have available several specific features of these devices. The aim of this study was to evaluate the relationship between real use of them and the degree of glycemic control in patients using this therapy. PATIENTS AND METHODS Forty-four T1DM patients on CSII therapy with or without real-time continuous glucose monitoring (CGM) were included. Data from 14 consecutive days were retrospectively collected using the therapy management software CareLink Personal/Pro(®) and HbA1c measurement performed at that period. The relationship between the frequency of usie of specific features of insulin pumps (non-sensor augmented or sensor-augmented) and glycemic control was analyzed. RESULTS Mean HbA1c in the group was 7.5 ± .8%. Mean daily number of boluses administered was 5.1 ± 1.8, with 75.4% of them being bolus wizards (BW). Daily number of boluses was significantly greater in patients with HbA1c <7.5% than in those with HbA1c>7.5% (5.3 ± 1.6 vs. 4.3 ± 1.6, P=.056). There was a trend to greater use of BW in patients with better control (82.8 ± 21.4% vs. 69.9 ± 29.1%, P=.106). HbA1c was lower in patients using CGM (n=8) as compared to those not using sensor-augmented pumps (7.6 ± .8 vs 7.1 ± .7, P=.067), but the difference was not statistically significant. CONCLUSIONS More frequent use of BW appears to be associated to better metabolic control in patients with T1DM using pump therapy. In standard clinical practice, augmentation of insulin pump with CGM may be associated to improved glycemic control.

Postpartum metabolic control in a cohort of women with type 1 diabetes

BACKGROUND AND OBJECTIVE Pregnancy in women with type 1 diabetes (T1D) involves greater risks as compared to non-diabetic women, but less information is available about blood glucose and weight control after delivery. Our aim was to evaluate the postpartum metabolic profile (blood glucose and weight control) of women with T1D and the factors related to those metabolic outcomes. METHODS A retrospective, observational study of 36 women with T1D during pregnancy and for up to one year after delivery. RESULTS Fifty percent of patients attended a preconceptional planning program (PPP), and 44.4% of women were treated with continuous subcutaneous insulin infusion. Mean preconceptional HbA1c and body mass index (BMI) were 7.2±1.2% and 23.8±5.0 respectively. In the total cohort, blood glucose control significantly worsened one year after delivery (HbA1c: 7.2±1.2 vs 7.6±1.2%, P<0.001). Lower preconceptional HbA1c values were found in patients who attended PPP (6.6±0.5 vs. 7.8±1.4%; P=0.02), and were maintained for one year after delivery. No differences were found in body mass index (BMI) from the pregestational period to one year after delivery in any of two groups (No PPP 22.5±4.6 vs 23.2±4.8, P=0.078; PPP 25.4±3.4 vs 25.5±3.4 kg/m(2), P=0.947). Preconceptional HbA1c was shown to be the most important determinant of metabolic control (β=0.962, p<0.001) and weight one year after delivery (β=0.524, p=0.025) and weight gain during pregnancy (β=0.633, p=0.004). CONCLUSIONS Pregnant women with T1D return to prepregnancy body weight one year after delivery, especially those with lower HbA1c levels and BMI before pregnancy. However, blood glucose control deteriorates after delivery, suggesting the need for changes in clinical practice after delivery.

Extensive Assessment of Blood Glucose Monitoring During Postprandial Period and Its Impact on Closed-Loop Performance:

Background: Closed-loop (CL) systems aims to outperform usual treatments in blood glucose control and continuous glucose monitors (CGM) are a key component in such systems. Meals represents one of the main disturbances in blood glucose control, and postprandial period (PP) is a challenging situation for both CL system and CGM accuracy. Methods: We performed an extensive analysis of sensor’s performance by numerical accuracy and precision during PP, as well as its influence in blood glucose control under CL therapy. Results: During PP the mean absolute relative difference (MARD) for both sensors presented lower accuracy in the hypoglycemic range (19.4 ± 12.8%) than in other ranges (12.2 ± 8.6% in euglycemic range and 9.3 ± 9.3% in hyperglycemic range). The overall MARD was 12.1 ± 8.2%. We have also observed lower MARD for rates of change between 0 and 2 mg/dl. In CL therapy, the 10 trials with the best sensor spent less time in hypoglycemia (PG < 70 mg/dl) than the 10 trials with the worst sensors (2 ± 7 minutes vs 32 ± 38 minutes, respectively). Conclusions: In terms of accuracy, our results resemble to previously reported. Furthermore, our results showed that sensors with the lowest MARD spent less time in hypoglycemic range, indicating that the performance of CL algorithm to control PP was related to sensor accuracy.

Impacto presupuestario de la infusión subcutánea continua de insulina en el tratamiento de pacientes con diabetes tipo 1 que presentan episodios de hipoglucemia grave recurrente en España

OBJECTIVE Hypoglycemia is one of the most common complications to achieve a good metabolic control, and has been listed by several scientific associations as a common indication to start treatment with continuous subcutaneous insulin infusion (CSII). Use of CSII is still residual in Spain as compared to neighbouring countries, and cost of acquisition cost is one of the main reasons. This study estimates the budget impact of treatment with CSII, as compared to multiple daily insulin injections, of patients with type 1 diabetes mellitus who experience recurrent severe hypoglycemia episodes from the National Healthcare System perspective. METHODS Budget impact was based on a retrospective, observational study evaluating the efficacy of CSII in patients with type 1 diabetes mellitus conducted at Hospital Clínic i Universitari in Barcelona, where one of the main indications for switching to CSII were recurrent severe hypoglycemia episodes. The mean number of annual episodes was 1.33 in the two years prior to CSII start and 0.08 in the last two years of follow up (p=0.003). Costs of treatment and major hypoglycemic events over a four-year period were considered. Costs were taken from different Spanish data sources and expressed in € of 2016. RESULTS Treatment with CSII increased costs by €9,509 per patient as compared to multiple daily insulin injections (€11,902-€2,393). Cost associated to severe hypoglycemic events decreased by €19,330 per patient treated with CSIII (€1,371-€20,701). Results suggest mean total savings of €9,821 per patient during the four-year study period. CONCLUSION The higher costs associated to CSII therapy may be totally offset by the severe hypoglycemic events prevented.

Experiences and real life management of insulin pump therapy in adults with type 1 diabetes

OBJECTIVE There is scarce information regarding the performance of a specific, structured education program addressed to patients with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) including both routine use of the therapy and patient experience evaluation. We aimed to assess the routine use of CSII and patients experience and satisfaction regarding a specific structured patient self-management education and care program. METHODS A retrospective, observational, cross-sectional study collecting CSII routine use downloaded data. Patient experience and satisfaction were evaluated using an anonymous online survey covering different aspects of CSII self-management education and care program. RESULTS 380 T1D subjects were included (aged 45.3±12.17 years, 62.1% women, diabetes duration 27.8±10.3 years, 9.7±4.7 years on CSII, HbA1c 7.7+1.0%; 61.0±7.9mmol/mol). Participants with HbA1c≤7.5% (58mmol/mol, n=178) did more SMBGs per day (4.4±2.1 vs. 3.9±1.9); used more boluses (5.0±1.8 vs. 4.5±2.0); the percentage of insulin given as bolus was higher (50.1±12.8 vs. 44.9±13.2%); the night bolus wizard (BW) high glucose target was lower (125.9±4.4 vs. 130.5±12.8mg/dl) and time on CSII therapy was shorter (8.9±4.6 vs. 10.3±4.6 years. p<0.05 all comparisons). More SMBG/day, shorter duration of CSII treatment, a lower BW low glucose target at night, a lower BW high glucose target at night, total insulin dose per day and total number of carbohydrates per day were related with better HbA1c levels. 60% of 373 patients answered the questionnaire. The response to the different aspects of the educational program was homogeneously highly satisfactory. Seventy-seven percent of patients scored the program as very useful. Ninety-three percent of CSII users would not return to their previous insulin treatment. CONCLUSIONS The analysis of routine clinical use of CSII by T1D patients demonstrates that glucose control may be associated with some pump usage and adherence parameters. The overall user experience and satisfaction with our CSII self-management education and care program was remarkably favorable.

Control de la glucemia durante el ejercicio físico aeróbico y anaeróbico mediante un nuevo sistema de páncreas artificial

AIM To assess an artificial pancreas system during aerobic (AeE) and anaerobic exercise (AnE). METHODS A pilot clinical trial on five subjects with type 1 diabetes (4 males) aged 37±10.9 years, diabetes diagnosed 21.2±12.2 years before, insulin pump users, and with a mean HbA1c level of 7.8±0.5%. Every subject did three AeE and three AnE sessions. Blood glucose levels were monitored by the artificial pancreas system during exercise and up to four hours later. Before the start of exercise, 23g of carbohydrates were administered orally. RESULTS The mean glucose level was 124.0±25.1mg/dL in the AeE studies and 152.1±34.1mg/dL in the AnE studies. Percent times in the different glucose ranges of 70-180, >180 and <70mg/dL were 89.8±18.6% and 75.9±27.6%; 7.7±18.4% and 23.2±28.0%; and 2.5±6.3% and 1.0±3.6% during the AeE and AnE sessions, respectively. Only six rescues with carbohydrates (15g) were required during the studies (4 in AeE and 2 in AnE). Total insulin dose during the five hours of the study was 3.1±1.0IU in the AeE studies and 3.5±1.3IU in the AnE studies. CONCLUSIONS Blood glucose response to AeE and AnE exercise is different. The evaluated artificial pancreas system appeared to achieve effective and safe blood glucose control during exercise and up to four hours later. However, new control strategies that minimize patient intervention should be designed.

Accuracy of Continuous Glucose Monitoring before, during, and after Aerobic and Anaerobic Exercise in Patients with Type 1 Diabetes Mellitus

Continuous glucose monitoring (CGM) plays an important role in treatment decisions for patients with type 1 diabetes under conventional or closed-loop therapy. Physical activity represents a great challenge for diabetes management as well as for CGM systems. In this work, the accuracy of CGM in the context of exercise is addressed. Six adults performed aerobic and anaerobic exercise sessions and used two Medtronic Paradigm Enlite-2 sensors under closed-loop therapy. CGM readings were compared with plasma glucose during different periods: one hour before exercise, during exercise, and four hours after the end of exercise. In aerobic sessions, the median absolute relative difference (MARD) increased from 9.5% before the beginning of exercise to 16.5% during exercise (p < 0.001), and then decreased to 9.3% in the first hour after the end of exercise (p < 0.001). For the anaerobic sessions, the MARD before exercise was 15.5% and increased without statistical significance to 16.8% during exercise realisation (p = 0.993), and then decreased to 12.7% in the first hour after the cessation of anaerobic activities (p = 0.095). Results indicate that CGM might present lower accuracy during aerobic exercise, but return to regular operation a few hours after exercise cessation. No significant impact for anaerobic exercise was found.