Marga Giménez

Outcome of pregnancy in women with type 1 diabetes intensively treated with continuous subcutaneous insulin infusion or conventional therapy. A case-control study.

The aim was to evaluate and compare the outcome of pregnancies of women with type 1 diabetes (T1D) intensively treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Twenty-nine women with T1D receiving CSII during pregnancy as intensive insulin therapy (27 started CSII during pregnancy planning while 2 started CSII during the 1st month of gestation) were matched for age, duration of T1D, Whites classification, BMI before gestation, parity and HbA1c before pregnancy with 29 women treated with MDI. Metabolic control and acute complications were registered including ketoacidosis and severe hypoglycaemic episodes, and the development of hypertension induced by pregnancy and pre-eclampsia. Perinatal mortality, stillbirth, minor and major congenital malformations, macrosomia, weeks at delivery, caesarean section and perinatal complications were also recorded. As expected, there were no differences between the two groups in terms of age, duration of the disease, Whites classification, BMI before gestation, parity and HbA1c before pregnancy. The proportion of subjects who received preconceptional guidance and planned pregnancy did not differ between groups. No differences were observed in HbA1c, insulin dose and BMI throughout gestation in either group of patients. Maternal, foetal and perinatal outcome were similar in women treated with CSII or MDI. The use of CSII in pregestational T1D women is associated with similar results in metabolic control, maternal, foetal and perinatal outcome during pregnancy to those obtained using MDI.

Hypoglycaemia and cardiovascular disease in Type 1 Diabetes. Results from the Catalan National Public Health registry on insulin pump therapy

Severe hypoglycaemia has recently been associated with an increased risk for cardiovascular disease (CVD) in diabetes. The retrospective analysis of a national registry on continuous subcutaneous insulin infusion points to a higher prevalence of CVD in Type 1 diabetic subjects with repeated severe hypoglycaemia at the time of starting CSII.

Glucose Control and Cardiovascular Disease: Is it important? No

There is a substantial amount of clinical data showing the relationship between diabetes and atherosclerosis and its clinical complications (1,2). Cardiovascular disease (CVD) is more common in people with diabetes than in subjects without the disease, and when it is present, it also has a more aggressive course and a worse prognosis (3). The bulk of epidemiological data has firmly established that type 2 diabetes is associated with more than a twofold increased risk for cardiovascular (CV) death. In the case of subjects with type 1 diabetes, in spite of the fact that the CVD rate is significantly lower compared with the population with type 2 diabetes, their relative risk for coronary heart mortality is sevenfold higher than in matched counterparts without the disease (4). Despite all of these data concerning the association of diabetes and CVD, the exact mechanism by which diabetes, and its alterations, is linked to atherosclerosis remains incompletely elucidated. This is especially true in the case of hyperglycemia. The role of nonglycemic factors that accompany the vast majority of patients with type 2 diabetes, such as high blood pressure, dyslipidemia, and hemorreological abnormalities, among others, is much better understood and seems to be independent of glycemia. In addition to this, there have been studies demonstrating that interventions addressed to control these other factors in patients with diabetes effectively reduce CV risk. There also have been data including the use of statins, aspirin, the aggressive management of hypertension, and the use of ACE inhibitors (5,6). Therefore, the positive effects that the control of other factors beyond hyperglycemia exert on CVD are, nowadays, unquestionable. In contrast, to date, the positive effect of intensive glucose management in comparison to nonintensive glucose control on CVD outcomes is still far from proven and seems unlikely to change …

Psychometric analysis of the Spanish and Catalan versions of the Diabetes Self-Care inventory- revised version questionnaire

Background The purpose of this study was to validate the Spanish and Catalan versions of the Diabetes Self-Care Inventory-Revised Version (SCI-R) questionnaire to assess the degree of adherence to self-care among adults with diabetes. Methods We validated the Spanish and Catalan translation from, and back translation to, English and cultural adaptation of the SCI-R in type 1 diabetes patients on multiple insulin doses or continuous subcutaneous insulin infusion and in type 2 diabetes patients on oral agents and/or insulin. Internal reliability, structural validity, and external validity (correlation with glycated hemoglobin) were evaluated. Responsiveness to change was assessed in patients 1 year after onset of type 1 diabetes and following a structured education program. Results The SCI-R presented good internal reliability Cronbach’s α: 0.75, test-retest reliability (r = 0.82) and structural validity (r > 0.40). The external validity was also good; the SCI-R correlated with HbA1c in patients with type 1 diabetes on multiple insulin doses (r = −0.50) or continuous subcutaneous insulin infusion (r = −0.66) and in patients with type 2 diabetes on multiple insulin doses (r = −0.62). However, it was not satisfactory in patients on oral agents (r = −0.20) and/or bedtime insulin (r = −0.35). Responsiveness to change was analyzed in 54 patients (age 27.3±7.4 years, 26% men, HbA1c 6.8% ±1.1%); the SCI-R score was 72.3% ±13.7% and correlated negatively with glycated hemoglobin (r = −0.42) and 3 scales of the Diabetes Quality of Life questionnaire (lower score indicating better perception): Impact (r = −0.37), Social Worry (r = −0.36) and Diabetes Worry (r = −0.38), all at P < 0.05. Conclusion The Spanish and Catalan versions of the SCI-R questionnaire show good psychometric properties and both could be considered as useful tools for evaluating self-care behavior in patients with type 1 or type 2 diabetes. However, there are still some subgroups of patients with type 2 diabetes in which the validity of this questionnaire needs further evaluation.

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.

Enfermedad cardiovascular en pacientes con diabetes mellitus tipo 1 y tipo 2 en España

BACKGROUND AND OBJECTIVE To describe the prevalence of cardiovascular disease (CVD) in type 1 diabetes (T1DM) and to compare it with that observed in type 2 diabetes (T2DM) and normal population in Spain. PATIENTS AND METHODS Cross-sectional study (18-70 years-old). Information on CVD was available from a nurse-administered questionnaire (Di@bet.es Study, NORMAL=3,430, T2DM=312) and from a physician reporting form (T1DM=1,382). Differences in the crude and adjusted prevalence of coronary heart (CHD), cerebrovascular (CNSD), peripheral vascular (PVD) and overall CV (CVD) disease were investigated between T1DM vs. NORMAL, and T1DM vs. T2DM groups. RESULTS We found differences in age, body mass index, proportion of women, dyslipemia and antihypertensive medication between T1DM vs. NORMAL and T1DM vs. T2DM (all P<.001). Smoking prevalence was not different between T1DM vs. T2DM and it was lower in T1DM compared to NORMAL (P<.0001). The percentage of CHD, CNSD, PVD, and overall CVD in T1DM vs. NORMAL was 3.0 vs. 2.5 (P=.31), 0.70 vs. 1.10 (P=.22), 2.61 vs. 0.20 (P<.0001), and 5.1 vs. 3.44 (P<.01), respectively. The prevalence in T2DM (vs. T1DM) was 11.3 (P<.0001), 3.5 (P<.0001), 4.2 (P=.13), and 17% (P<.0001), respectively. Multiple logistic regression adjusted models showed a higher prevalence of CHD (odds ratio [OR] 2.27, 95% confidence interval [95% CI] 1.41-3.67), PVD (OR 15.35, 95% CI 5.61-42.04), and overall CVD (OR 2.32, 95% CI 1.55-3.46), but not for CNSD (OR 0.49, 95% CI 0.19-1.27) in T1DM compared to NORMAL. No differences were found between T1DM and T2DM. CONCLUSIONS We found a higher prevalence of CVD in a Mediterranean population of T1DM individuals compared with non-diabetic subjects. This prevalence was similar to that observed in T2DM.

Accuracy and Predictive Value of Classification Schemes for Ketosis-Prone Diabetes Response to Balasubramanyam et al.

We have read with interest the study by Balasubramanyam et al. (1). They described a new classification scheme (Aβ classification) based on C-peptide levels and the presence or absence of β-cell autoantibodies to predict long-term β-cell function and insulin independence in patients who presented with diabetic ketoacidosis (DKA). They reported a sensitivity of 99.4%, a specificity of 95.9%, and a positive likelihood ratio (LR) of 24.55 in the total cohort of 294 subjects. In the subset of 138 subjects presenting with DKA as new-onset diabetes, 99.1%, 95.5%, and 21.79 sensitivity, specificity, and positive LR, respectively, were observed. To evaluate the performance of this new classification in a Caucasian-Spanish population, 40 consecutive adult …

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.

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.