Cost-effectiveness analysis of sensor-augmented pump therapy with low glucose-suspend in patients with type 1 diabetes mellitus and high risk of hypoglycemia in Spain / Análisis coste-utilidad del sistema integrado con suspensión en hipoglucemia en pacientes con diabetes tipo 1 y alto riesgo de hipoglucemias en España

Objective: To compare the cost-effectiveness of sensor-augmented pump therapy (SAP) [continuous subcutaneous insulin infusion (CSII) plus real-time continuous glucose monitoring (RT-CGM)] with low glucose suspend (MiniMed(TM) Veo(TM)) and CSII alone in patients with type 1 diabetes mellitus (T1DM) at high risk of hypoglycemia in Spain. Methods: The IQVIA CORE Diabetes Model was used to estimate healthcare outcomes as life-years gained (LYGs) and quality-adjusted life years (QALYs), and to project lifetime costs. Information about efficacy, resource utilization, and unit costs (€2016) was taken from published sources and validated by an expert panel. Analyses were performed from both the Spanish National Health System (NHS) perspective and the societal perspective. Results: From the NHS perspective, SAP with low glucose suspend was associated to a €47,665 increase in direct healthcare costs and to increases of 0.19 LYGs and 1.88 QALYs, both discounted, which resulted in an incremental cost-effectiveness ratio (ICER) of €25,394/QALY. From the societal perspective, SAP with low glucose suspend increased total costs (including direct and indirect healthcare costs) by €41,036, with a resultant ICER of €21,862/QALY. Considering the willingness-to-pay threshold of €30,000/QALY in Spain, SAP with low glucose suspend represents a cost-effective option from both the NHS and societal perspectives. Sensitivity analyses confirmed the robustness of the model. Conclusions: From both the Spanish NHS perspective and the societal perspective, SAP with low glucose suspend is a cost-effective option for the treatment of T1DM patients at high risk of hypoglycemia

Objetivo: Evaluar la relación coste-utilidad del sistema integrado (MiniMed(R) Veo(R)) con suspensión en hipoglucemia frente a la infusión subcutánea continua de insulina (ISCI) en el tratamiento de pacientes con diabetes tipo 1 (DM1) y alto riesgo de hipoglucemias en España. Métodos: Se utilizó el modelo de diabetes IQVIA CORE para estimar los resultados en salud expresados como años de vida ganados (AVG) y años de vida ajustados por calidad (AVAC) y los costes a lo largo de la vida de los pacientes. La información sobre la eficacia, el consumo de recursos y los costes unitarios (2016€) fue obtenida de fuentes publicadas y validadas por un panel de expertos. En el escenario principal se consideró la perspectiva del Sistema Nacional de Salud (SNS) y, en un escenario alternativo, la de la sociedad en general. Resultados: Bajo la perspectiva del SNS el tratamiento con el sistema integrado con suspensión en hipoglucemia se asoció con mayores costes sanitarios directos (47.665€) y un incremento de 0,19 AVG y 1,88 AVAC, resultando en un ratio coste-utilidad incremental (RCUI) de 25.394€/AVAC. Considerando la perspectiva de la sociedad, los costes totales (sanitarios directos e indirectos) se incrementaron en 41.036€, siendo el RCUI resultante de 21.862€/AVAC. Los análisis de sensibilidad confirmaron la robustez de los resultados en todos los escenarios evaluados. Conclusión: Considerando el umbral de máxima disposición a pagar para España de 30.000€/AVAC, el sistema integrado con suspensión en hipoglucemia representa una opción eficiente en comparación con la ISCI tanto desde la perspectiva del SNS como de la sociedad en su conjunto

Cost-effectiveness analysis of sensor-augmented pump therapy with low glucose-suspend in patients with type 1 diabetes mellitus and high risk of hypoglycemia in Spain.

OBJECTIVE: To compare the cost-effectiveness of sensor-augmented pump therapy (SAP) [continuous subcutaneous insulin infusion (CSII) plus real-time continuous glucose monitoring (RT-CGM)] with low glucose suspend (MiniMed™ Veo™) and CSII alone in patients with type 1 diabetes mellitus (T1DM) at high risk of hypoglycemia in Spain. METHODS: The IQVIA CORE Diabetes Model was used to estimate healthcare outcomes as life-years gained (LYGs) and quality-adjusted life years (QALYs), and to project lifetime costs. Information about efficacy, resource utilization, and unit costs (€2016) was taken from published sources and validated by an expert panel. Analyses were performed from both the Spanish National Health System (NHS) perspective and the societal perspective. RESULTS: From the NHS perspective, SAP with low glucose suspend was associated to a €47,665 increase in direct healthcare costs and to increases of 0.19 LYGs and 1.88 QALYs, both discounted, which resulted in an incremental cost-effectiveness ratio (ICER) of €25,394/QALY. From the societal perspective, SAP with low glucose suspend increased total costs (including direct and indirect healthcare costs) by €41,036, with a resultant ICER of €21,862/QALY. Considering the willingness-to-pay threshold of €30,000/QALY in Spain, SAP with low glucose suspend represents a cost-effective option from both the NHS and societal perspectives. Sensitivity analyses confirmed the robustness of the model. CONCLUSIONS: From both the Spanish NHS perspective and the societal perspective, SAP with low glucose suspend is a cost-effective option for the treatment of T1DM patients at high risk of hypoglycemia.

ViDa1: The Development and Validation of a New Questionnaire for Measuring Health-Related Quality of Life in Patients with Type 1 Diabetes.

This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [([Formula: see text] 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 -0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes.

Position statement on efficiency of technologies for diabetes management.

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality are of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring nd self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the directones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease.

Documento de posicionamiento sobre la eficiencia de las tecnologías aplicadas al manejo de la diabetes / Position statement on efficiency of technologies for diabetes management

Las cifras del estudio Di@bet.es en España son contundentes: la diabetes afecta al 13,8% de la población española. Pero si los datos estadísticos son alarmantes, el mayor problema lo constituye el ritmo de crecimiento, y las previsiones calculan en poco tiempo proporciones pandémicas de diabetes tipo 2 que pondrán en riesgo el estado de bienestar. Por ello, la diabetes no solo representa un desafío importante para los servicios de salud, sino que pasa a ser un reto para los Ministerios de Sanidad y Economía. La tecnología se ha convertido en una herramienta imprescindible en la atención de calidad del paciente con diabetes, pues facilita los procesos de atención y cuidados para obtener un buen control metabólico y prevenir las complicaciones. Las bombas de insulina, los sensores de glucosa y la automonitorización de la glucemia capilar ya han probado su eficiencia, y la telemedicina está en vías de hacerlo. Los costes indirectos de la diabetes en España son mucho más elevados que los directos, lo cual no deja de ser una paradoja que debemos invertir. La optimización de los recursos dependerá de la habilidad que tengamos los profesionales y la administración para implantar y mantener la innovación tecnológica en todos sus niveles y hacerla eficaz en la ecuación que examina los datos económicos y los beneficios. Los análisis de coste-efectividad y coste-utilidad son necesarios para establecer prioridades y permitir tomar decisiones de gestión sanitaria, que en el caso de enfermedades tan prevalentes como la diabetes tienen repercusiones directas en el gasto sanitario

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality care of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring and self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the direct ones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease

Documento de posicionamiento sobre la eficiencia de las tecnologías aplicadas al manejo de la diabetes / Position statement on efficiency of technologies for diabetes management

Las cifras del estudio Di@bet.es en España son contundentes: la diabetes afecta al 13,8% de la población española. Pero si los datos estadísticos son alarmantes, el mayor problema lo constituye el ritmo de crecimiento, y las previsiones calculan en poco tiempo proporciones pandémicas de diabetes tipo 2 que pondrán en riesgo el estado de bienestar. Por ello, la diabetes no solo representa un desafío importante para los servicios de salud, sino que pasa a ser un reto para los Ministerios de Sanidad y Economía. La tecnología se ha convertido en una herramienta imprescindible en la atención de calidad del paciente con diabetes, pues facilita los procesos de atención y cuidados para obtener un buen control metabólico y prevenir las complicaciones. Las bombas de insulina, los sensores de glucosa y la automonitorización de la glucemia capilar ya han probado su eficiencia, y la telemedicina está en vías de hacerlo. Los costes indirectos de la diabetes en España son mucho más elevados que los directos, lo cual no deja de ser una paradoja que debemos invertir. La optimización de los recursos dependerá de la habilidad que tengamos los profesionales y la administración para implantar y mantener la innovación tecnológica en todos sus niveles y hacerla eficaz en la ecuación que examina los datos económicos y los beneficios. Los análisis de coste-efectividad y coste-utilidad son necesarios para establecer prioridades y permitir tomar decisiones de gestión sanitaria, que en el caso de enfermedades tan prevalentes como la diabetes tienen repercusiones directas en el gasto sanitario

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality care of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring and self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the direct ones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease

Experiencia en el uso de insulina lispro durante el embarazo en mujeres con diabetes mellitus pregestacional / Use of insulin lispro during pregnancy in women with pregestational diabetes mellitus

Fundamento y objetivo: Evaluar la seguridad y eficacia de los análogos de insulina en comparación con insulina humana en mujeres embarazadas con diabetes pregestacional. Pacientes y métodos: Se recogieron datos de las embarazadas con diabetes tipo 1 o 2 que fueron atendidas en la Unidad de Diabetes y Embarazo entre enero de 1998 y abril de 2008 (n=351). Doscientas cuarenta y una pacientes fueron tratadas con insulina regular y NPH, y 110 fueron tratadas con diferentes combinaciones de insulinas incluyendo un análogo de insulina (la mayoría con NPH y lispro). Resultados:No hubo diferencias en cuanto a malformaciones congénitas entre ambos grupos (3,3 y 3,6%). El grupo con análogo de insulina tuvo una HbA1c ligeramente más alta que el grupo con insulina humana durante el primer trimestre (6,9 [1,1]% vs 6,6 [1,0]%; p=0,022) y necesitó menor dosis de insulina durante todo el embarazo. La hipoglucemia grave fue significativamente menos frecuente entre las mujeres tratadas con un análogo de insulina rápida (2,3 vs 10,0%; p=0,025). La hipoglucemia neonatal fue significativamente más frecuente en dicho grupo (34,9 vs 23,6%; p=0,043) en relación con el uso concomitante de bomba de insulina. Otras variables obstétricas y neonatales no fueron diferentes entre ambos grupos (AU)

Background and objective: To assess the safety and efficacy of insulin analogues versus human insulin in pregnant women with pregestational diabetes. Patients and methods: We collected data on pregnant women with type 1 or type 2 diabetes who were attended at the Diabetes and Pregnancy Unit between January 1998 and April 2008 (N=351). Two hundred and forty one patients were treated with regular insulin and NPH and 110 were treated with different combinations of insulins including an insulin analogue (most of them with NPH and lispro). Results:There was no significant difference in terms of congenital malformation rate between groups (3.3% and 3.6%). The group on insulin analogue had slightly higher mean HbA1c during the first trimester than the group on human insulin (6.6 [1.0]% vs 6.9 [1.1]%; P=0,022) and needed smaller insulin doses during whole pregnancy. Severe hypoglycaemia was significantly less frequent among women treated with a rapid insulin analogue (2.3 vs 10.0%; P=0,025). Neonatal hypoglycaemia was significantly more frequent in the group treated with a rapid insulin analogue (34.9 vs 23.6%; P=0.043) due to the concomitant use of an insulin pump. Other obstetric and neonatal variables were not different between the two groups. Conclusion: Our study shows that insulin analogues are safe during pregnancy in women with pregestational diabetes mellitus. Overall, glycaemic control, maternal and foetal outcome were similar to those with human insulin. The main advantage with respect to human insulin was to importantly reduce maternal severe hypoglycaemia (AU)

Use of insulin lispro during pregnancy in women with pregestational diabetes mellitus.

BACKGROUND AND OBJECTIVE: To assess the safety and efficacy of insulin analogues versus human insulin in pregnant women with pregestational diabetes. PATIENTS AND METHODS: We collected data on pregnant women with type 1 or type 2 diabetes who were attended at the Diabetes and Pregnancy Unit between January 1998 and April 2008 (N=351). Two hundred and forty one patients were treated with regular insulin and NPH and 110 were treated with different combinations of insulins including an insulin analogue (most of them with NPH and lispro). RESULTS: There was no significant difference in terms of congenital malformation rate between groups (3.3% and 3.6%). The group on insulin analogue had slightly higher mean HbA1c during the first trimester than the group on human insulin (6.6 [1.0]% vs 6.9 [1.1]%; P=0,022) and needed smaller insulin doses during whole pregnancy. Severe hypoglycaemia was significantly less frequent among women treated with a rapid insulin analogue (2.3 vs 10.0%; P=0,025). Neonatal hypoglycaemia was significantly more frequent in the group treated with a rapid insulin analogue (34.9 vs 23.6%; P=0.043) due to the concomitant use of an insulin pump. Other obstetric and neonatal variables were not different between the two groups. CONCLUSION: Our study shows that insulin analogues are safe during pregnancy in women with pregestational diabetes mellitus. Overall, glycaemic control, maternal and foetal outcome were similar to those with human insulin. The main advantage with respect to human insulin was to importantly reduce maternal severe hypoglycaemia.

Solitary hemorrhagic cerebellar metastasis from occult papillary thyroid microcarcinoma.

BACKGROUND: Cerebellar metastasis (CM) from papillary thyroid carcinoma (PTC) is exceptional with only 12 reported cases and usually carries a very poor prognosis. In the two previously reported patients in whom CM was detected before PTC, other distant or local metastases were already present by the time of PTC diagnosis. We report a patient found to have papillary thyroid microcarcinoma after surgical resection and histopathological study of a large solitary hemorrhagic CM, who showed no evidence of other metastatic sites and survived 7 years after initial diagnosis. SUMMARY: A 65-year-old female patient with a history of surgical resection of a 7-cm cerebellar mass diagnosed with PTC metastasis, and adjuvant treatment with cranial external radiotherapy, was referred to us. The neck ultrasonography showed a solitary 4-mm right thyroid nodule. Histopathology after total thyroidectomy revealed a 2-mm papillary thyroid microcarcinoma, sclerosing variant, with capsule infiltration but no regional lymph node invasion. Although she received a total dose of 500 mCi of 131-I after surgery and the last two whole-body scans were normal, serum thyroglobulin levels progressively increased. The patient refused any further test or treatment other than basal blood sampling and suppressive therapy with levothyroxine and remained stable for 4 years until she started to complain about deviation of her walk. A computed tomography scan showed a regrowth of the metastasis. She suffered a sudden worsening of her neurological status because of a big intratumoral hemorrhage that required decompressive craniectomy and hematoma evacuation surviving 3 years more after this episode. CONCLUSIONS: To our knowledge, this is the first reported case of a solitary CM from an occult PTC, and also the first that developed an acute cerebellar hemorrhage years after cranial surgery, however, exhibiting the longest reported survival. This case highlights the importance of not only an appropriate initial treatment of the CM and primary PTC in these patients, but also a close follow-up, to avoid further complications and improve their prognosis.

Maternal third trimester hyperglycaemic excursions predict large-for-gestational-age infants in type 1 diabetic pregnancy.

OBJECTIVE: To determine which maternal glycaemic parameters in type 1 diabetes better predict large-for-gestational-age (LGA) infants. METHODS: Maternal glycaemic parameters (mean overall, preprandial, and postprandial glucose; the percentage of glucose readings above and below target and HbA1c levels) of LGA (n=37) and appropriate-for-gestational-age (n=36) infants were compared during preconception and each trimester of pregnancy. Logistic regression was used to select predictive variables. RESULTS: Preconception glycaemic parameters were not different. Mean glucose and the percentage of glucose readings above target were higher in mothers of LGA infants in every trimester of pregnancy. Second and third trimesters mean postprandial glucose, third trimester mean preprandial glucose and third trimester HbA1c were also higher. Only third trimester glycaemic variables were risk indicators of LGA infants: mean glucose (OR: 3.45; 95% CI: 1.52-7.80), mean preprandial glucose (OR: 2.97; 95% CI: 1.34-6.60), mean postprandial glucose (OR: 2.09; 95% CI: 1.19-3.67) and the percentage of glucose readings above target (OR: 1.08; 95% CI: 1.03-1.14). The percentage of glucose readings above target was the best risk indicator. CONCLUSIONS: Third trimester glycaemic parameters are more powerful predictors of foetal growth than glycaemic parameters earlier in pregnancy or during preconception. Hyperglycaemic excursions are the strongest predictor of LGA infants.

Carcinoma papilar tiroideo asociado a linfoma. A propósito de tres casos / Lymphoma-associated papillary thyroid carcinoma. A report of three cases

El tiroides es una glándula sumamente sensible a la radiación externa. Los estudios epidemiológicos han demostrado que los efectos carcinogénicos de la radiación sobre el tiroides son máximos durante la infancia y decrecen tras 30 años de la exposición, aunque no desaparezcan. El efecto es también dosis-dependiente, aunque pueda producirse a dosis bajas. Los carcinomas que aparecen son generalmente papilares con un comportamiento similar a los no radioinducidos, aunque en muchas ocasiones son multifocales. En el linfoma de Hodgkin, con cierta frecuencia aparece un segundo tumor, ya sea como efecto secundario al tratamiento o bien en el contexto de un síndrome genético. Presentamos 3 casos de carcinoma papilar tiroideo asociados a linfoma. En el primero, el linfoma apareció 18 años antes del cáncer tiroideo y fue tratado con radioterapia, pero no durante la infancia. En los otros 2, el carcinoma papilar tiroideo aparece previamente al linfoma y no existen antecedentes de radiación

The thyroid gland is extremely sensitive to external radiation. Epidemiological studies have demonstrated that the carcinogenic effects of radiation on the thyroid reach a peak during childhood and decrease after 30 years of exposure, although they do not disappear. The effect is also dose-dependent, although it can be produced by low doses. The carcinomas that develop are generally papillary with similar behavior to those not induced by radiation, although they are often multifocal. In Hodgkin´s disease, a second tumor may sometimes develop, either as an adverse effect of treatment or in the context of a genetic syndrome. We present 3 cases of thyroid papillary carcinoma associated with lymphoma. In the first patient, the lymphoma developed 18 years before the thyroid cancer, and was treated with radiotherapy, but not in childhood. In the remaining 2 patients, the papillary carcinoma developed before the lymphoma, with no antecedents of radiation

[Insulin pumps]. / Bombas de insulina.

Treatment with insulin in form of continued subcutaneous infusions is intended to mimic the normal pancreatic function. Insulin pumps are currently a reality and they allow for an improvement of glycemic oscillations and contribute to decrease HbA1c and to improve patient's quality of life. Infusion systems are quite advanced and the challenge at present are glycemia sensors. There are several trials under way which are trying to establish if it is possible for sensors to work with a closed-loop system. In the meantime, patients will continue to perform (and interpret) glycemic controls. The role of physicians must be to advice patients about diabetes and the management of pumps so that they are able to minimize hypoglycemias and optimize glycemic controls.

Impaired fasting glucose and impaired glucose tolerance in women with prior gestational diabetes are associated with a different cardiovascular profile.

OBJECTIVE: The purpose of this study was to investigate the association of cardiovascular risk factors to impaired glucose tolerance (IGT) and to impaired fasting glucose (IFG) in women with prior gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: We studied 838 women with prior GDM. Postpartum glucose tolerance status was classified as normal, IFG, IGT, IFG plus IGT, and diabetes according to the World Health Organization criteria. Postpartum BMI, waist circumference, blood pressure, triglyceride, cholesterol, and HDL cholesterol were assessed. RESULTS: BMI and blood pressure were significantly higher in women with IFG than in women with normal glucose status. BMI and waist circumference were significantly higher in women with IFG plus IGT than in women with normal glucose status. No differences were observed between women with IGT and normal glucose status. The prevalence of hypertension and obesity was significantly increased in IFG compared with normal glucose status. The prevalence of obesity and abnormal lipids was significantly increased in IFG plus IGT compared with normal glucose status. IGT showed no increased prevalence of cardiovascular risk factors. CONCLUSIONS: Traditional cardiovascular risk factors have a stronger association with isolated IFG than with isolated IGT in women with prior GDM.

Influencia del control metabólico preconcepcional en la evolución de la gestación de la paciente diabética / Role of glycosylated hemoglobin of preconception stage in diabetic pregnancy outcome

FUNDAMENTO: En la paciente diabética es preciso un control metabólico estricto en los momentos previos a la concepción y en las primeras semanas del embarazo para disminuir la morbilidad maternofetal. En nuestro estudio tratamos de comprobar si dicho control se relaciona o no con la aparición de abortos y de complicaciones neonatales. PACIENTES Y MÉTODO: Se examina a 69 pacientes diabéticas, 62 diabéticas tipo 1 y 7 diabéticas tipo 2, sometidas a control preconcepcional en la unidad de diabetes y embarazo en el período 1992-1998. Se llevó a cabo control metabólico en el período preconcepcional y a lo largo de la gestación. Se analiza la relación entre los parámetros de control metabólico en el período preconcepcional inmediato y la evolución de la gestación. RESULTADOS: Un total de 50 mujeres (72,6 por ciento; intervalo de confianza [IC] del 95 por ciento: 62-83 por ciento) finalizaron el control preconcepcional con embarazo. De estas pacientes, 8 (16 por ciento; IC del 95 por ciento: 5,5-27 por ciento) abortaron. No hubo diferencias entre las pacientes que abortaron y las que no, en relación con la hemoglobina glucosilada (HbA1c) con que terminaron el control preconcepcional, edad, tiempo de evolución de la diabetes y edad al diagnóstico, presencia de anticuerpos antitiroideos o de vasculopatía. En los 41 embarazos con feto único, hubo macrosomía en un 36,6 por ciento (IC del 95 por ciento: 21,2-52 por ciento), hipoglucemia neonatal en un 19,5 por ciento (IC del 95 por ciento: 6,9-32 por ciento) y malformaciones graves en un caso (2,4 por ciento; IC del 95 por ciento 2-7,4 por ciento). La HbA1c media (desviación estándar) de las 41 pacientes embarazadas con feto único al inicio del período preconcepcional fue del 7,6 (1,3) (IC del 95 por ciento: 7,1-7,9 por ciento) y al final de dicho período del 6,5 por ciento (0,7) (IC del 95 por ciento: 6,3-6,7 por ciento) (p < 0,0001). La HbA1c con que finalizaron el control preconcepcional fue del 6,8 por ciento (0,7) (IC del 95 por ciento: 6,5-7,2 por ciento) para el grupo con macrosomía frente al 6,3 por ciento (0,7) (IC del 95 por ciento: 6-6,6 por ciento) para el grupo sin macrosomía (p = 0,019). Dicha HbA1c evidenció una correlación lineal con el peso del recién nacido (r = 0,432; p = 0,014), el índice ponderal fetal (r = 0,450; p = 0,009), y con una puntuación de morbilidad (r = 0,458; p = 0,007). CONCLUSIÓN: Un mejor control metabólico en el período preconcepcional puede contribuir a disminuir la incidencia de macrosomía y de morbilidad neonatal (AU)