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.

Cambios glucémicos durante el ciclo menstrual en mujeres con diabetes mellitus tipo 1 / Glycemic changes during menstrual cycles in women with type 1 diabetes

Fundamento y objetivo: Determinar la frecuencia de mujeres con diabetes tipo 1 que experimentan cambios glucémicos durante el ciclo menstrual, analizar sus características clínicas, y evaluar el patrón de los cambios glucémicos. Pacientes y métodos: Analizamos las lecturas de los glucómetros a lo largo de 168 ciclos menstruales en 26 mujeres con diabetes tipo 1. Evaluamos la glucemia media, la desviación estándar media, la glucemia media basal, el porcentaje de lecturas > 7,8 mmol/l y < 3,1 mmol/l, y la dosis de insulina media en 4 períodos de cada ciclo. Se consideró que una mujer tenía cambios cíclicos cuando la glucemia media se elevó entre la fase folicular temprana y la fase lútea tardía en dos tercios de sus ciclos menstruales. Resultados: El 65,4% de las mujeres experimentaron cambios cíclicos. Las características de las mujeres con y sin cambios cíclicos, incluyendo la autopercepción de cambios glucémicos, fueron similares, exceptuando la edad de diagnóstico de la diabetes (22,5 [7,5] frente a 14,4 [9,5] años; p = 0,039). En mujeres con cambios cíclicos el porcentaje medio de los valores de glucosa > 7,8 mmol/l se elevó entre la fase folicular temprana (52,2 [16,3] %) y la fase lútea temprana y tardía (58,4 [16,0] %, p = 0,0269; 61,0 [16,9] %, p = 0,000). Conclusión: Casi dos tercios de las mujeres con diabetes tipo 1 experimentan fenómenos del ciclo menstrual atribuibles a un incremento de las excursiones hiperglucémicas durante la fase lútea. Posibilitar que las mujeres evalúen su glucemia media semanal a partir de las lecturas de los glucómetros, y explorar las causas de las excursiones hiperglucémicas durante la fase lútea podría garantizar una mayor precisión al impartir instrucciones para la gestión de la diabetes en mujeres con hiperglucemia premenstrual (AU)

Background and objective: To determine frequency of women with type 1 diabetes showing menstrual cyclic changes in glycemia, analyze their clinical characteristics, and assess the pattern of glycemic changes. Patients and methods: We analyzed glucose meter readings along 168 menstrual cycles of 26 women with type 1 diabetes. We evaluated mean glucose, mean glucose standard deviation, mean fasting glucose, percentage of glucose readings > 7.8 mmol/L and < 3.1 mmol/L, and mean insulin dose in 4 periods for each cycle. A woman was identified as having cyclic changes when mean glucose rose from early follicular to late luteal in two-thirds of her menstrual cycles. Results: A percentage of 65.4 of the women had cyclic changes. Characteristics of women with and without cyclic changes, including self-perception of glycemic changes, were similar with exception of age at diabetes diagnosis (22.5 [7.5] vs. 14.4 [9.5] years; P = .039). In women with cyclic changes mean percentage of glucose readings > 7.8 mmol/L rose from early follicular (52.2 [16.3] %) to early and late luteal (58.4 [16.0] %, P = .0269; 61.0 [16.9] %, P = .000). Conclusion: Almost two-thirds of women with type 1 diabetes experience a menstrual cycle phenomenon, attributable to an increase in hyperglycemic excursions during the luteal phase. Enabling women to evaluate their weekly mean glucose from their meter and exploring the causes of hyperglycemic excursions during luteal phase should ensure more accuracy when giving instructions for diabetes management in women with premenstrual hyperglycemia (AU)

[Glycemic changes during menstrual cycles in women with type 1 diabetes]. / Cambios glucémicos durante el ciclo menstrual en mujeres con diabetes mellitus tipo 1.

BACKGROUND AND OBJECTIVE: To determine frequency of women with type 1 diabetes showing menstrual cyclic changes in glycemia, analyze their clinical characteristics, and assess the pattern of glycemic changes. PATIENTS AND METHODS: We analyzed glucose meter readings along 168 menstrual cycles of 26 women with type 1 diabetes. We evaluated mean glucose, mean glucose standard deviation, mean fasting glucose, percentage of glucose readings>7.8 mmol/L and<3.1 mmol/L, and mean insulin dose in 4 periods for each cycle. A woman was identified as having cyclic changes when mean glucose rose from early follicular to late luteal in two-thirds of her menstrual cycles. RESULTS: A percentage of 65.4 of the women had cyclic changes. Characteristics of women with and without cyclic changes, including self-perception of glycemic changes, were similar with exception of age at diabetes diagnosis (22.5 [7.5] vs. 14.4 [9.5] years; P=.039). In women with cyclic changes mean percentage of glucose readings>7.8 mmol/L rose from early follicular (52.2 [16.3] %) to early and late luteal (58.4 [16.0] %, P=.0269; 61.0 [16.9] %, P=.000). CONCLUSION: Almost two-thirds of women with type 1 diabetes experience a menstrual cycle phenomenon, attributable to an increase in hyperglycemic excursions during the luteal phase. Enabling women to evaluate their weekly mean glucose from their meter and exploring the causes of hyperglycemic excursions during luteal phase should ensure more accuracy when giving instructions for diabetes management in women with premenstrual hyperglycemia.

Factores de riesgo de complicaciones vasculares en extremidades inferiores en los pacientes con diabetes / Risk factors of vascular complications in lower limbs in diabetic patients

Fundamento y Objetivo: Evaluar en el paciente con diabetes los factores de riesgo que se asocian a la aparición de complicaciones vasculares en extremidades inferiores. Pacientes y método: Estudio longitudinal retrospectivo en el que se evalúan 270 pacientes con diabetes seguidos en el Hospital la Paz desde 2000 hasta 2008. Medimos el índice tobillo-brazo (ITB), índice dedo-brazo (IDB) y presión arterial (PA) del primer dedo. Definimos evento vascular en extremidades inferiores. Comparamos distintas variables clínicas y epidemiológicas entre los pacientes con y sin evento vascular. Con un modelo de regresión de Cox se valora qué variables presentan asociación independiente con la aparición de evento. Resultados: Los valores medios de ITB, IDB y PA del primer dedo son significativamente menores en los pacientes con evento (ITB medio [DE] de 0,92 [0,30] frente a 0,78 [0,46], p=0,007; IDB medio de 0,86 [4,40] frente a 0,42 [0,22], p=0,001; PA media de 72,08 [30,62] frente a 56,25 [29,51], p=0,014). Resulta significativa la asociación de evento vascular con alteraciones biomecánicas (p=0,022), úlceras activas (p=0,000), antiguas (p=0,000) e insensibilidad (p=0,023). En la regresión de Cox demostraron tener valor independiente el IDB (hazard ratio [HR] 0,05; intervalo de confianza del 95% [IC 95%] 0,00-0,52; p=0,013), alteraciones biomecánicas (HR 4,92; IC 95% 1,13-18,75; p=0,019), úlceras activas (HR 3,26; IC 95% 1,37-7,79; p=0,008) y previas (HR 5,55; IC 95%1,85-16,59; p=0,002). Conclusión: Los factores que nos sirven para predecir de forma independiente la aparición de eventos vasculares en extremidades inferiores en el futuro son el IDB, la existencia de alteraciones biomecánicas en los pies y el haber presentado úlceras. Son independientes de la edad, tipo de diabetes o existencia de otras complicaciones micro o macrovasculares de la misma (AU)

Background and Objetive: To evaluate the risk factors of complications in lower limbs in diabetic patients. Patients and methods: We evaluated 270 patients with diabetes followed in Hospital la Paz from 2000 to 2008.We measured the ankle-brachial index (ABI), toe-brachial index (TBII), and toe blood pressure (BP). We defined vascular complications in lower limbs. We compared some epidemiological and clinical variables between patients with and without a vascular event. We analyzed which variables have an independent association with the later appearance of a vascular event with Cox regression model. Results: The mean value of ITB, IDB and toe blood pressure were significantly lower in patients who had a vascular event compared to those who had not presented it (ITB mean 0.92±0.30 vs 0.78±0.46, P=.007; IDB mean 0.86±4.40 vs 0.42±0.22, P=.001; PA mean 72.08±30.62 vs 56.25±29.51, P=.014).The association of vascular event and biomechanical abnormalities (P=.022), active and old ulcers (P=.000), and insensivity (P=.023) were significantly. In the Cox regression model the toe brachial index (HR 0.05; IC:0.00-0.52; P=.013), the active (HR 3.26; IC:1.37-7.79; P=.008) and old ulcers (HR 5.55; IC:1.85-16.59; P=.002). and the biomechanical abnormalities (HR 4.92; IC:1.13-18.75; P=.019) had an independent value.Conclusions: Toe brachial index, biomechanical abnormalities and ulcers have an independent value to predict the later appearance of vascular events. In addition, they are independent of the age, type of diabetes and others diabetic complications (AU)

[Risk factors of vascular complications in lower limbs in diabetic patients]. / Factores de riesgo de complicaciones vasculares en extremidades inferiores en los pacientes con diabetes.

BACKGROUND AND OBJECTIVE: To evaluate the risk factors of complications in lower limbs in diabetic patients. PATIENTS AND METHODS: We evaluated 270 patients with diabetes followed in Hospital la Paz from 2000 to 2008.We measured the ankle-brachial index (ABI), toe-brachial index (TBII), and toe blood pressure (BP). We defined vascular complications in lower limbs. We compared some epidemiological and clinical variables between patients with and without a vascular event. We analyzed which variables have an independent association with the later appearance of a vascular event with Cox regression model. RESULTS: The mean value of ITB, IDB and toe blood pressure were significantly lower in patients who had a vascular event compared to those who had not presented it (ITB mean 0.92±0.30 vs 0.78±0.46, P=.007; IDB mean 0.86±4.40 vs 0.42±0.22, P=.001; PA mean 72.08±30.62 vs 56.25±29.51, P=.014).The association of vascular event and biomechanical abnormalities (P=.022), active and old ulcers (P=.000), and insensivity (P=.023) were significantly. In the Cox regression model the toe brachial index (HR 0.05; IC:0.00-0.52; P=.013), the active (HR 3.26; IC:1.37-7.79; P=.008) and old ulcers (HR 5.55; IC:1.85-16.59; P=.002). and the biomechanical abnormalities (HR 4.92; IC:1.13-18.75; P=.019) had an independent value. CONCLUSIONS: Toe brachial index, biomechanical abnormalities and ulcers have an independent value to predict the later appearance of vascular events. In addition, they are independent of the age, type of diabetes and others diabetic complications.

Assessing glycaemic variability with continuous glucose monitoring system before and after continuous subcutaneous insulin infusion in people with Type 1 diabetes.

We evaluated glycaemic variability with continuous glucose monitoring system in 31 people with Type 1 diabetes mellitus using multiple daily injections initially and after switching to continuous subcutaneous insulin infusion. There was a significant improvement in HbA1c, mean glucose, standard deviation of mean glucose and in hyperglycaemic excursions with CSII.