The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy.

OBJECTIVE: This study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). METHODS: We compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. RESULTS: The CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14-0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. CONCLUSIONS: CDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up.

OBJECTIVE: To evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. METHODS: This was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. RESULTS: 162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (-0.9%, 95% CI: 0.5-1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7-2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (-8.1%, 95% CI: -16.5 to 0.3; p=0.03). CONCLUSIONS: SAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy.

OBJECTIVE: This study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). METHODS: We compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. RESULTS: The CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14-0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. CONCLUSIONS: CDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up.

OBJECTIVE: To evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. METHODS: This was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. RESULTS: 162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (-0.9%, 95% CI: 0.5-1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7-2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (-8.1%, 95% CI: -16.5 to 0.3; p=0.03). CONCLUSIONS: SAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

Eclampsia y síndrome HELLP en los Andes del Perú: complicaciones perinatales / Eclampsia and HELLP syndrome in the Peruvian Andes: perinatal complications

Resumen OBJETIVO: Comparar las complicaciones perinatales en pacientes con eclampsia, síndrome HELLP y su asociación. MATERIALES Y MÉTODOS: Estudio transversal y comparativo efectuado en mujeres con eclampsia, síndrome HELLP, o ambos, y sus neonatos atendidas en el Hospital Regional Docente de Cajamarca, Perú, entre el 1 de enero y el 31 de diciembre de 2015. La información se procesó con el programa Epi Info versión 7. Se usó la ANOVA y χ2 no paramétrica con Kruskal-Wallis para comparar grupos, y se consideró significativo un valor de p < 0.05. RESULTADOS: Se registraron 3411 nacimientos; 71 pacientes tuvieron eclampsia o síndrome HELLP. Las complicaciones perinatales de prematurez, menor peso y talla al nacer y Apgar más bajo fueron significativamente mayores en mujeres con síndrome HELLP que con eclampsia. En cuanto a prematurez hubo 30 (66.6%) casos de madres con síndrome HELLP, 14 (70%) con eclampsia asociada con síndrome HELLP y ninguno con eclampsia (p = 0.01). El peso promedio al nacimiento fue 2133.5 ± 66.7 g en síndrome HELLP y 3083.1 ± 67.8 g en eclampsia (p = 0.001). Hubo Apgar más bajo al minuto y a los cinco minutos en la combinación eclampsia y síndrome HELLP que en solo eclampsia (p = 0.002). No hubo diferencias significativas en la mortalidad, restricción del crecimiento fetal, asfixia neonatal, taquipnea transitoria, enfermedad de membranas hialinas, enterocolitis necrotizante, policitemia, ictericia patológica o sepsis. La tasa de cesáreas en síndrome HELLP fue 41 (91.1%) y en eclampsia 4 (66.6%) (p = 0.03). CONCLUSIONES: Las complicaciones perinatales son mayores pacientes con síndrome HELLP que con eclampsia.

Abstract OBJECTIVES: To compare perinatal complications in patients with eclampsia, HELLP syndrome and association. MATERIALS AND METHODS: a cross-sectional, comparative study conducted in women with eclampsia and / or HELLP syndrome and their perinates in Hospital Regional Docente de Cajamarca , Peru. Data obtained from 01/01/2015 to 12/31/15. Information processing was carried out with the Epi Info program version 7. The ANOVA and non-parametric χ2 with Kruskal-Wallis were used to compare groups, and a value of P <0.05 was considered significant. RESULTS: 71 women had eclampsia and / or HELLP syndrome of 3411 births. Perinatal complications such as prematurity, lower weight and height at birth and lower Apgar were significantly higher in HELLP syndrome than in eclampsia. Regarding prematurity, there were 30 (66.6%) in HELLP syndrome, 14 (70%) in eclampsia associated with HELLP syndrome and none in eclampsia (p = 0.01). Birth weight was 2133.5 ± 66.7 g in HELLP syndrome and 3083.1 ± 67.8 g in eclampsia (p = 0.001). Apgar was lower at minute and at 5 minutes in the combination eclampsia and HELLP syndrome than in eclampsia alone (p = 0.002). There were no significant differences in mortality, IUGR, neonatal asphyxia, transient tachypnea, hyaline membrane disease, necrotizing enterocolitis, polycythemia, pathological jaundice or sepsis. The rate of cesareans in HELLP syndrome was 41 (91.1%) and in eclampsia 4 (66.6%) (p = 0.03). CONCLUSIONS: Perinatal complications are greater in HELLP syndrome than in eclampsia.

Cumplimiento de la normatividad en lapublicidad de medicamentos de ventalibre en Colombia / Fulfillment of the normatividad in the advertising medicine of free sale in Colombia

Introducción: en Colombia la información sobre el cumplimento de la normativa de publicidad de medicamentos de venta libre es limitada.Objetivo: establecer el cumplimiento normativo de la publicidad televisiva de medicamentos de venta libre en Colombia.Métodos: en julio de 2012, la transmisión de 2 canales nacionales (Caracol y RCN)y 1 regional (Teleantioquia) se grabó en forma simultánea entre las 6:00 y 22:00 horas, durante 2 días de semana y 2 días de fin de semana o festivo, seleccionados probabilísticamente con el programa Epi-info V. 6.0.Resultados: en los canales nacionales de 378 anuncios (de 54 medicamentos), 31(8.2 por ciento) de 3 medicamentos no cumplieron con la normatividad. Por su parte en el canal regional, aunque hubo 7 anuncios de 5 productos farmacéuticos, no se identificó publicidad de medicamentos de venta libre.Conclusiones: en un porcentaje pequeño (8 por ciento), los anuncios televisivos de medicamentos de venta libre en los canales nacionales no cumplen con la normativa vigente.