Experiences and real life management of insulin pump therapy in adults with type 1 diabetes / Experiencias y gestión en la vida real del tratamiento con bomba de insulina de adultos con diabetes tipo 1

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 patient's 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

Objetivo: Hay poca información sobre la eficacia de un programa educativo estructurado específico dirigido a los pacientes con diabetes tipo 1 (DT1) que utilizan infusión subcutánea continua de insulina (ISCI) que incluye tanto el uso habitual del tratamiento como la evaluación de la experiencia de los pacientes. Nuestro objetivo era valorar el uso habitual de la ISCI, la experiencia y la satisfacción del paciente con un programa educativo y asistencial estructurado específico para autogestión de los pacientes. Métodos: Estudio transversal retrospectivo observacional en el que se recogieron datos descargados sobre el uso habitual de la ISCI. Se evaluaron la experiencia y la satisfacción de los pacientes mediante una encuesta en línea anónima que abarcaba distintos aspectos del programa educativo y asistencial para autogestión de la ISCI. Resultados: Se incluyó a 380 pacientes con DT1 (45,3±12,17 años de edad, 62,1% mujeres, duración de la diabetes 27,8±10,3 años, 9,7±4,7 años con ISCI, HbA1c 7,7+1,0%; 61,0±7,9mmol/mol). Los participantes con HbA1c<7,5% (58mmol/mol, n=178) practicaron más autocontroles al día (4,4±2,1 vs. 3,9±1,9); usaron más bolos (5,0±1,8 vs. 4,5±2,0); tuvieron un porcentaje de insulina administrada en bolo mayor (50,1±12,8 vs. 44,9±13,2%) y el objetivo de glucosa nocturna alta en el recomendador de bolo (bolus wizard, BW) era más bajo (125,9±4,4 vs. 130,5±12,8mg/dl), y su tiempo con ISCI era menor (8,9±4,6 vs. 10,3±4,6 años, p<0,05 para todas las comparaciones). Más autocontroles al día, la menor duración del tratamiento con ISCI, un objetivo de glucosa baja del BW menor por la noche, un objetivo de glucosa alta del BW por la noche menor, la dosis total diaria de insulina y el número total de hidratos de carbono diarios estaban relacionados con mejores valores de HbA1c. El 60% de 373 pacientes contestaron el cuestionario. La respuesta a los distintos aspectos del programa educativo fue muy satisfactoria en conjunto. El 77% de los pacientes valoraron el programa como muy útil. El 93% de los usuarios de ISCI no volverían el tratamiento de insulina previo. Conclusiones: El análisis del uso clínico sistemático de la ISCI por pacientes con DT1 demuestra que el control de la glucosa puede relacionarse con algunos parámetros de uso y cumplimiento de la bomba. La experiencia global del usuario y la satisfacción con nuestro programa educativo y asistencial de autogestión de la ISCI fueron notablemente favorables

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 patient's 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.

Programa de atención y educación terapéutica en el debut de la diabetes tipo 2: un nuevo modelo de abordaje en atención primaria / Health care and therapeutic education program for newly diagnosed type 2 diabetes: A new approach in primary care

Introducción: A pesar de la evidencia favorable, existen pocas iniciativas en nuestro sistema público sobre programas específicos de educación terapéutica estructurada dirigidos a pacientes con diagnóstico reciente de diabetes tipo 2 (DM2), un momento de especial importancia en la evolución posterior de la enfermedad. Objetivos: Evaluar la efectividad del Programa de Atención y educación Terapéutica en el debut de la DM2 (PAET-Debut DM2) de ámbito territorial y consensuado entre centros de Atención Primaria y Hospital de referencia. Métodos: Estudio piloto prospectivo en pacientes con edad >18 años diagnosticados de DM2 entre febrero 2012-2013. El PAET-DebutDM2 se planifica e implementa en 4 Centros de Atención Primaria del área de referencia del Hospital Clínic de Barcelona. Se identifican referentes (médico de familia y enfermera) en cada centro y se realiza formación específica para estandarización de procesos clínicos y metodología de educación terapéutica. Se evalúan resultados a los 6 y 12 meses. Resultados: Se propone el programa a 345 pacientes, 191(55,3%) son incluidos, finalizando 134(70,2%). Al finalizar el programa el 84% de pacientes está en objetivos de control (HbA1c<7%) y 88% completa el cribado de complicaciones crónicas. Observamos una mejora del peso corporal, de la actividad física (p<0,001), del nivel de conocimientos (p<0,05), y constatamos menos urgencias hospitalarias por DM comparados con los no incluidos (p=0,023). Conclusión: El PAET-DebutDM2 estandariza la intervención, la educación y es efectivo en los resultados clínicos, educativos y de satisfacción del paciente. Enfatiza la importancia de la educación y de la intervención desde el debut, y reordena recursos, sin incrementar la presión asistencial en el centro de atención primaria, reduciendo la atención hospitalaria

Introduction: Despite the favorable evidence available, our public health care system has no specific programs including therapeutic education for patients newly diagnosed with type 2 diabetes (T2DM), which would be crucial for the subsequent course of the disease. Objectives: To assess the effectiveness of a "Health care and Therapeutic Education Program for newly diagnosed type 2 diabetes (PAET-Debut DM2)" agreed by the primary care centers and the reference hospital in a given geographical area. Methods: A prospective pilot study in patients over 18 years of age diagnosed with T2DM between February 2012 and 2013. The PAET-DebutDM2 is planned and set up in four primary care centers in the area covered by Hospital Clínic in Barcelona. Reference persons (family doctor and nurse) are designated at each center and specific training is provided to standardize the clinical processes and therapeutic education methods. First results are assessed and compared at 6 and 12 months. Results: The program was proposed to 345 patients, of which 191 (55.3%) were enrolled in it and 134 (70.2%) completed the program. At the end of the program, 84% achieved the control goal (HbA1c <7%) and 88% passed the screening of chronic complications. Improvements were seen in body weight, physical activity (p<0,001), and disease awareness (p<0.05), and there were less hospital emergencies due to DM as compared to patients not included in the program (p=0.023). Conclusion: The PAET-DebutDM2 standardizes intervention and education and is effective in terms of clinical and educational results and patient satisfaction. The program emphasizes the importance of early education and intervention, reorganizing resources without increasing care pressure in the primary care centers, thus reducing hospital care

Health care and therapeutic education program for newly diagnosed type 2 diabetes: A new approach in primary care. / Programa de atención y educación terapéutica en el debut de la diabetes tipo 2: un nuevo modelo de abordaje en atención primaria.

INTRODUCTION: Despite the favorable evidence available, our public health care system has no specific programs including therapeutic education for patients newly diagnosed with type 2 diabetes (T2DM), which would be crucial for the subsequent course of the disease. OBJECTIVES: To assess the effectiveness of a "Health care and Therapeutic Education Program for newly diagnosed type 2 diabetes (PAET-Debut DM2)" agreed by the primary care centers and the reference hospital in a given geographical area. METHODS: A prospective pilot study in patients over 18 years of age diagnosed with T2DM between February 2012 and 2013. The PAET-DebutDM2 is planned and set up in four primary care centers in the area covered by Hospital Clínic in Barcelona. Reference persons (family doctor and nurse) are designated at each center and specific training is provided to standardize the clinical processes and therapeutic education methods. First results are assessed and compared at 6 and 12 months. RESULTS: The program was proposed to 345 patients, of which 191 (55.3%) were enrolled in it and 134 (70.2%) completed the program. At the end of the program, 84% achieved the control goal (HbA1c <7%) and 88% passed the screening of chronic complications. Improvements were seen in body weight, physical activity (p<0,001), and disease awareness (p<0.05), and there were less hospital emergencies due to DM as compared to patients not included in the program (p=0.023). CONCLUSION: The PAET-DebutDM2 standardizes intervention and education and is effective in terms of clinical and educational results and patient satisfaction. The program emphasizes the importance of early education and intervention, reorganizing resources without increasing care pressure in the primary care centers, thus reducing hospital care.

Detailed description of a prepregnancy care program and its impact on maternal glucose control, weight gain, and dropouts.

BACKGROUND: The aim of this study was to analyze the clinical and metabolic changes observed during a prepregnancy care (PPC) program. METHODS: We performed a retrospective, observational, cohort study of 104 women with type 1 diabetes initiating a PPC program from 2011 to 2014. The outcomes measured were changes in HbA1c levels, weight and hypoglycemic events during PPC. Risk factors associated with severe hypoglycemia events, achieving the HbA1c target and dropouts were evaluated. RESULTS: HbA1c decreased from 7.2 ± 0.8% (55.3 ± 8.8 mmol/mol) to 6.7 ± 0.9% (49.8 ± 10.3 mmol/mol) (P < .001) within a median of 14.2 months (interquartile interval 5.4-23.2); 71.2% obtained HbA1c  < 7% (53 mmol/mol). HbA1c at the end of PPC was associated with baseline HbA1c (ß = .318, P = .001) and the number of previous pregnancies (ß = .224, P = .038), PPC was accompanied by 1.4 ± 4.0 kg weight gain (P = .003) without changes in severe hypoglycemic events. The risk factors for severe hypoglycemia were severe hypoglycemic events during the 2 years before (odds ratio [OR] 11.99, confidence interval 95% 1.89-75.95) and PPC duration (OR 1.09, 1.03-1.16). A total of 33 patients (31.7%) dropped out from PPC during follow-up, with dropout being associated with age (OR 1.17, 1.04-1.36) and PPC duration (OR 1.06, 1.02-1.11). CONCLUSIONS: Our PPC program was associated with an improvement in glycemic control without a significant increase in severe hypoglycemic events, although with some weight gain. A considerable number of patients dropped out during follow-up, this being related to older age and a longer duration of the program. This information could be of help to design new and more effective PPC approaches. Copyright © 2016 John Wiley & Sons, Ltd.

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.