Glucose Variability After Bariatric Surgery: Is Prediction of Diabetes Remission Possible?

We aimed to corroborate glycemic control after bariatric surgery (BS) using continuous glucose monitoring (CGM) and analyze if data could predict long-term outcome. We evaluated 24 of our patients with type 2 diabetes who underwent BS (12 Roux-en-Y gastric bypass, RYGB, and 12 single-anastomosis duodeno-ileal bypass with sleeve gastrectomy, SADI-S) and who were in remission after 18-24 months' follow-up. At this time, a CGM device was placed for 7 days. Patients were reevaluated thereafter for at least 5 years. Glucose variability (GV) was lower in patients after SADI-S and in the 18 patients who were still in remission after 5 years, and provided more information on long-term status than classical diabetes-related characteristics.

What is the most effective exercise protocol to improve cardiovascular fitness in overweight and obese subjects?

BACKGROUND: Increased peak oxygen consumption (VO2peak) can reduce cardiovascular risks associated with obesity. Our aim was to analyze the effect of a weight loss program on cardiovascular fitness in overweight (W) and obese (O) subjects. METHODS: One hundred and sixty-seven subjects (77 males and 90 females), aged 18-50 years, performed a modified Bruce protocol before (pre) and after (post) a weight loss program of 24 weeks. This program combined physical training (strength, S; endurance, E; combined strength + endurance, SE; or physical activity recommendation, PA) 3 times per week, with a 25%-30% caloric restriction diet. RESULTS: VO2peak improved in overweight and obese males (pre and post values in L/min, respectively; W = 3.2 ± 0.6 vs. 3.7 ± 0.5, p < 0.001; O = 3.6 ± 0.6 vs. 3.8 ± 0.6, p = 0.013) as well as in overweight females (2.0 ± 0.3 vs. 2.3 ± 0.4, p < 0.001). VO2peak in the first ventilatory threshold (VT1) increased for all 4 interventions in males (p < 0.05), except for S in the obese group (1.6 ± 0.2 vs. 1.7 ± 0.3, p = 0.141). In females, it increased in E (0.9 ± 0.2 vs. 1.4 ± 0.3, p < 0.001), SE (0.9 ± 0.2 vs. 1.2 ± 0.4, p = 0.003), and PA (0.9 ± 0.1 vs. 1.2 ± 0.2, p = 0.006) in overweight groups. Time-to-exhaustion improved in all subjects except for females in PA group (15.7 ± 0.3 min vs. 15.9 ± 0.3 min, p = 0.495). CONCLUSION: Our results suggest that all methods, including the recommendation of physical activity, can improve cardiovascular fitness in overweight subjects and obese males.

Análisis psicométrico de las versiones en lengua castellana y catalana de un cuestionario de percepción de la hipoglucemia / Psychometric analysis of the Spanish and Catalan versions of a questionnaire for hypoglycemia awareness

Fundamento y objetivo: El tratamiento intensivo con múltiples dosis de insulina de los pacientes con diabetes mellitus tipo 1 (DT1) se asocia con la aparición de hipoglucemias. Su recurrencia condiciona la pérdida progresiva de los síntomas asociados a las mismas y predispone a la aparición de episodios graves. Es importante disponer de cuestionarios específicos y validados para identificar a los pacientes con este problema. Con este objetivo se realizó el análisis psicométrico de las versiones castellana y catalana del cuestionario de Clarke et al. destinado a valorar la percepción de hipoglucemias. Pacientes y método: Análisis psicométrico en pacientes con DT1 de las versiones en castellano y catalán del cuestionario de Clarke et al. en 3 fases: 1) traducción, retrotraducción y adaptación cultural de la versión en inglés; 2) análisis de la consistencia interna, validez de constructo y test-retest del mismo, y 3) análisis de su sensibilidad al cambio en la percepción de hipoglucemias. Resultados: Ciento cuarenta y cuatro pacientes con DT1 contestaron los cuestionarios en lengua castellana o catalana, según preferencias (edad media [DE] de 36 [18] años, 46% varones). Se obtuvo un coeficiente a de Cronbach para la consistencia interna de 0,75, un coeficiente de correlación para la fiabilidad test-retest de r = 0,81 y una correlación de la puntuación del cuestionario con la frecuencia de hipoglucemias no graves y graves de r = 0,47 y r = 0,77, respectivamente. El análisis de 20 pacientes con DT1 durante 24 meses tras el inicio de infusión subcutánea continua de insulina mostro´ una disminución de la frecuencia de hipoglucemias no graves/semana (de una media de 5,40 [2,09] a 2,75 [1,74]), así como del número de episodios de hipoglucemia grave/año (de una media de 1,25 [0,44] a 0,05 [0,22]). Esta reducción se asoció con una mejora en la percepción de la hipoglucemia, con una disminución de la puntuación del cuestionario de Clarke et al. (de 5,45 [1,19] a 1,60 [2,03]). Conclusiones: Las versiones en lengua castellana y catalana del cuestionario de Clarke et al. Tienen buenas características psicométricas y pueden ser un instrumento útil para evaluar la presencia de hipoglucemia desapercibida en pacientes con DT1 de nuestro entorno (AU)

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 a 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 (AU)

[Psychometric analysis of the Spanish and Catalan versions of a questionnaire for hypoglycemia awareness]. / 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.

Introduction of IADPSG criteria for the screening and diagnosis of gestational diabetes mellitus results in improved pregnancy outcomes at a lower cost in a large cohort of pregnant women: the St. Carlos Gestational Diabetes Study.

OBJECTIVE: The use of the new International Association of the Diabetes and Pregnancy Study Groups criteria (IADPSGC) for the diagnosis of gestational diabetes mellitus (GDM) results in an increased prevalence of GDM. Whether their introduction improves pregnancy outcomes has yet to be established. We sought to evaluate the cost-effectiveness of one-step IADPSGC for screening and diagnosis of GDM compared with traditional two-step Carpenter-Coustan (CC) criteria. RESEARCH DESIGN AND METHODS: GDM risk factors and pregnancy and newborn outcomes were prospectively assessed in 1,750 pregnant women from April 2011 to March 2012 using CC and in 1,526 pregnant women from April 2012 to March 2013 using IADPSGC between 24 and 28 weeks of gestation. Both groups received the same treatment and follow-up regimes. RESULTS: The use of IADPSGC resulted in an important increase in GDM rate (35.5% vs. 10.6%) and an improvement in pregnancy outcomes, with a decrease in the rate of gestational hypertension (4.1 to 3.5%: -14.6%, P < 0.021), prematurity (6.4 to 5.7%: -10.9%, P < 0.039), cesarean section (25.4 to 19.7%: -23.9%, P < 0.002), small for gestational age (7.7 to 7.1%: -6.5%, P < 0.042), large for gestational age (4.6 to 3.7%: -20%, P < 0.004), Apgar 1-min score <7 (3.8 to 3.5%: -9%, P < 0.015), and admission to neonatal intensive care unit (8.2 to 6.2%: -24.4%, P < 0.001). Estimated cost savings was of €14,358.06 per 100 women evaluated using IADPSGC versus the group diagnosed using CC. CONCLUSIONS: The application of the new IADPSGC was associated with a 3.5-fold increase in GDM prevalence in our study population, as well as significant improvements in pregnancy outcomes, and was cost-effective. Our results support their adoption.

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.

Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression--the St Carlos study : a 3-year, prospective, randomized, clinic-based, interventional study with parallel groups.

The aims are to define the regression rate in newly diagnosed type 2 diabetes after lifestyle intervention and pharmacological therapy based on a SMBG (self-monitoring of blood glucose) strategy in routine practice as compared to standard HbA1c-based treatment and to assess whether a supervised exercise program has additional effects. St Carlos study is a 3-year, prospective, randomized, clinic-based, interventional study with three parallel groups. Hundred and ninety-five patients were randomized to the SMBG intervention group [I group; n = 130; Ia: SMBG (n = 65) and Ib: SMBG + supervised exercise (n = 65)] and to the HbA1c control group (C group) (n = 65). The primary outcome was to estimate the regression rate of type 2 diabetes (HbA1c <6 % on metformin treatment). After 3 years of follow-up, diabetes regression was achieved by 56 patients, 6 (9.2 %) from the C group, 21 (32.3 %) from the Ia group and 29 (44.6 %) from the Ib group. RR (95 % CI) for diabetes regression in the intervention group (Ia + Ib) was 4.5 (2.1-9); p < 0.001 and remained after stratification by gender, age and BMI. This difference was associated with healthier changes in lifestyle and greater weight loss. RR for a weight loss >4 kg was 3.6 (1.8-7); p < 0.001. This study shows that the use of SMBG in an educational program effectively increases the regression rate in newly diagnosed type 2 diabetic patients after 3 years of follow-up. These data suggest that SMBG-based programs should be extended to primary care settings where diabetic patients are usually attended.

Evaluación de la técnica de análisis domiciliario de glucemia capilar entre la población con diabetes de siete comunidades autónomas de España / Evaluation of the home blood glucose self-monitoring technique among the population with diabetes in seven Spanish regions

Introducción. Son conocidas la importancia y la trascendencia de la técnica de glucemia capilar, que puede mejorar el control metabólico de las personas con diabetes mellitus (DM). Objetivos. Conocer y evaluar la realización correcta de la técnica de glucemia capilar entre la población con DM y comparar, si existe, correlacion entre esta técnica y la frecuencia de autoanálisis con el grado de control glucémico de la enfermedad. Materiales y método. Estudio multicéntrico, aleatorizado y sistemático en el que se incluyó a personas con DM de siete comunidades autónomas de España, que realizaron análisis domiciliarios de glucemia capilar entre el 1 de enero y el 30 de septiembre de 2010. Resultados. Se analizaron los datos de 455 pacientes con una distribución por zona geográfica y sexo (53%, mujeres; 47%, varones). En cuanto a la evaluación sobre la técnica de glucemia capilar y glucómetros utilizados, un 87% reutiliza las lancetas (40%, más de 10 veces). El 42% no realiza rotación en zonas de punción. Sólo el 58% refiere lavado previo de manos y el 13% utiliza antisépticos, mayoritariamente alcohol. Un 20% no tiene un criterio claro de cuándo y para qué hacerse autoanálisis y un 60% no modifica su tratamiento tras los resultados. El 89% de los pacientes del estudio presentaba un dispositivo para la punción capilar sucio y/o roto. El 60% de los glucómetros requería algún tipo de codificación previa, y en 20 de ellos era incorrecta; el 26% no tenía mensajes de alerta y un 4% presentaba tiras caducadas. Un 9% de la muestra no tenía hemoglobina glucosilada (HbA1C) registrada (83% eran pacientes con DM tipo 2) y el 70% de las registradas era superior al 7%. Conclusiones. Los resultados obtenidos en nuestro estudio muestran la necesidad no sólo de enseñar la realización correcta de la técnica de autoanálisis, sino también que los profesionales la evalúen de forma periódica, así como revisar los glucómetros, los dispositivos de punción capilar y las zonas de punción de los dedos. Teniendo en cuenta que la tasa de reutilización de lancetas encontrada es muy elevada, cabe reflexionar sobre la bioseguridad de los pacientes que realizan esta práctica. En cuanto a los sistemas utilizados, se ha observado un conocimiento escaso de ellos sobre cuestiones tan importantes como codificación, caducidad de tiras, mensajes de alerta, entre otros, unas especificaciones que son importantes y que pueden alterar el resultado real y, por tanto, la toma de decisiones. Un número importante de pacientes presentaba un mal control metabólico, que coincidía con otras series publicadas y, a pesar de las recomendaciones actuales propuestas por las sociedades científicas, no se realizaron las modificaciones indicadas por ellas en relación con la frecuencia tanto de HbA1C, como de autoanálisis(AU)

Background. The importance and significance of the blood glucose self monitoring technique on improving the quality of life in people with diabetes is well known. Objectives. To determine and evaluate the correct performance of the blood glucose self-monitoring technique among the diabetes mellitus population and to compare this technique and the blood glucose self-monitoring frequency with the degree of glycaemic control of the disease. Material and methods. It is a multicentre, randomised and systematic study in which a population with diabetes mellitus from seven Spanish Regions who performed home blood glucose self-monitoring tests between January 1st and September 30th 2010 were included. Results. Data from 455 patients were analyzed with an equal distribution regarding geographic area and gender (53% females, 47% males). Related to the evaluation of the blood glucose self monitoring technique and the glucose meters used for this purpose, 87% re-used the lancets (40% more than 10 times). 42% did not rotate puncture areas. Only 58% mentioned a previous hand-washing and 13% used antiseptics, mainly alcohol. Some patients (20%) had no clear idea about when and for what purpose they performed the blood glucose self-monitoring test and 60% did not modify the treatment according to the results. Most of the study patients (89 %) had a dirty and/or broken capillary puncture device. The majority (60%) of the glucose meters required some kind of previous coding, which was not correct in 20 of them; 26% did not have alert messages and 4% had expired test strips. Nine per cent of the sample had not recorded any HbA1C (83% were DM2 patients) and 70% of those recorded were > 7%. Conclusions. According to the results of our study, it is shown that not teaching the correct use of the blood glucose self-monitoring technique is needed, but it must also be evaluated periodically by the professionals. Both the glucose meters and capillary puncture devices also need to be reviewed, taking into account the very high re-use rate of the lancets found. We must think carefully about the biosecurity of the patients who perform this technique. Regarding the used devices, a lack of knowledge about them is shown as regards important issues such as coding, test strips expiry date and alert messages among others. These are very important as they are able to alter the true results, and therefore the decission making process. A high number of patients had poor metabolic control, which is in agreemnt other published series and, despite the current recommendations proposed by the Scientific Societies, the modifications suggested related to the frequency of both HbA1C and blood glucose self-monitoring were not performed(AU)

The outcomes of gestational diabetes mellitus after a telecare approach are not inferior to traditional outpatient clinic visits.

Objective. To evaluate the feasibility of a telemedicine system based on Internet and a short message service in pregnancy and its influence on delivery and neonatal outcomes of women with gestational diabetes mellitus (GDM). Methods. 100 women diagnosed of GDM were randomized into two parallel groups, a control group based on traditional face-to-face outpatient clinic visits and an intervention group, which was provided with a Telemedicine system for the transmission of capillary glucose data and short text messages with weekly professional feedback. 97 women completed the study (48/49, resp.). Main Outcomes Measured. The percentage of women achieving HbA1c values <5.8%, normal vaginal delivery and having a large for-gestational-age newborn were evaluated. Results. Despite a significant reduction in outpatient clinic visits in the experimental group, particularly in insulin-treated women (2.4 versus 4.6 hours per insulin-treated woman resp.; P < .001), no significant differences were found between the experimental and traditional groups regarding HbA1c levels (all women had HbA1c <5.8% during pregnancy), normal vaginal delivery (40.8% versus 54.2%, resp.; P > .05) and large-for-gestational-age newborns (6.1% versus 8.3%, resp.; P > .05). Conclusions. The system significantly reduces the need for outpatient clinic visits and achieves similar pregnancy, delivery, and newborn outcomes.

A Telemedicine system based on Internet and short message service as a new approach in the follow-up of patients with gestational diabetes.

To evaluate the feasibility of a Telemedicine system based on Internet and short message service in the follow-up of patients with gestational diabetes. Compared to control group, Telemedicine group reduced 62% the number of unscheduled face-to-face visits, and 82.7% in the subgroup of insulin-treated patients, improving patient satisfaction, and achieving similar pregnancy and new born outcomes.