7 research outputs found

    Diabetes gestacional: factores de riesgo, programas de seguimiento durante la gestación y prevención de diabetes tipo 2 en el período postgestacional

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    Estudio 1. Efecto del estilo de vida sobre el riesgo de diabetes gestacional en mujeres inmigrantes hispanas residentes en España. Hipótesis de trabajo. Existen datos limitados sobre los hábitos de alimentación y los factores de riesgo de DG de la población inmigrante de etnia hispana residente en España. El conocimiento de los aspectos diferenciales en cuanto a factores de riesgo, si los hubiera, respecto a la población española permitiría diseñar de forma más adaptada las estrategias preventivas dirigidas a la población inmigrante. Objetivo. Comparar los factores de riesgo relacionados con el estilo de vida para el desarrollo de la DG en mujeres españolas y en mujeres de etnia hispana residentes en España y sus resultados en cuanto a evolución de la gestación, del parto y del recién nacido. Estudio 2. Asociación de concentraciones bajas de 25-hidroxi-vitamina D materna con los parámetros de la homeostasis de la glucosa y con los resultados obstétricos y del recién nacido. Hipótesis de trabajo. El déficit de 25-hidroxi-vitamina D (25-OH-vitD) materna como factor de riesgo emergente para el desarrollo de DG ha resultado controvertido en estudios previos. Por otra parte, los niveles de 25-OH-vitD también podrían estar implicados en una adecuada evolución de la gestación, del parto y del recién nacido. El estudio de estas asociaciones permitirá evaluar las recomendaciones actuales sobre suplementación con vitamina D durante la gestación. Objetivo. Evaluar la asociación de los niveles de 25-OH-vitD materna durante la gestación con los parámetros de la homeostasis de la glucosa y con el riesgo de DG y con los resultados obstétricos y del recién nacido. Estudio 3. Aplicación de la Telemedicina como nueva aproximación para facilitar el seguimiento de la diabetes gestacional. Comparación frente al seguimiento tradicional con visitas presenciales. Hipótesis de trabajo. Nuevos modelos asistenciales dirigidos a la mujer con DG son necesarios para compatibilizar un seguimiento médico estrecho con su estilo de vida. Los sistemas telemáticos ofrecen una vía para facilitar el proceso de atención, disminuyendo el número de visitas presenciales. El seguimiento de las pacientes con DG mediante un sistema de telemedicina puede no ser inferior al seguimiento convencional con visitas presenciales. Objetivo. Evaluar la viabilidad, eficacia y seguridad de un sistema de telemedicina basado en telefonía móvil e internet para la monitorización de glucemia capilar en el seguimiento de pacientes con diabetes gestacional frente al seguimiento convencional con visitas presenciales. Estudio 4. Desarrollo de diabetes mellitus y tolerancia anormal a la glucosa después de haber presentado diabetes gestacional, estudio prospectivo a tres años, aleatorizado, basado en la práctica clínica con intervención sobre el estilo de vida. Hipótesis de trabajo. Las mujeres que han presentado DG tienen un incremento del riesgo de desarrollo de disglucosis en el periodo post-gestacional. La hipótesis del estudio es evaluar la reducción en la aparición de alteraciones de la homeostasis de la glucosa tras un programa de asesoramiento nutricional basado en la adherencia a la dieta mediterránea y un programa de ejercicio físico supervisado, comparado con el tratamiento estándar, en mujeres que fueron diagnosticadas de diabetes gestacional y que presentaron glucosa basal normal entre las 6 y 12 semanas postparto. Objetivo. Comparar el efecto de un seguimiento convencional frente a una intervención nutricional y un programa supervisado de actividad física en la prevención de alteraciones de la glucosa a los tres años de haber presentado DG

    Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial

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    Background: There is no established insulin regimen in T2DM patients receiving parenteral nutrition. Aims: To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN. Design: Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous Gl. Data were analyzed according to intention-to-treat principle. Results: 81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 +/- 35.4 in RI vs 172.5 +/- 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 +/- 45.1 in RI vs 141.7 +/- 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose <= 70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality. Conclusion: Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group. (C) 2019 The Author(s). Published by Elsevier Ltd

    Fish Oil Enriched Intravenous Lipid Emulsions Reduce Triglyceride Levels in Non-Critically Ill Patients with TPN and Type 2 Diabetes. A Post-Hoc Analysis of the INSUPAR Study

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    There are no studies that have specifically assessed the role of intravenous lipid emulsions (ILE) enriched with fish oil in people with diabetes receiving total parenteral nutrition (TPN). The objective of this study was to assess the metabolic control (glycemic and lipid) and in-hospital complications that occurred in non-critically ill inpatients with TPN and type 2 diabetes with regard to the use of fish oil emulsions compared with other ILEs. We performed a post-hoc analysis of the Insulin in Parenteral Nutrition (INSUPAR) trial that included patients who started with TPN for any cause and that would predictably continue with TPN for at least five days. The study included 161 patients who started with TPN for any cause. There were 80 patients (49.7%) on fish oil enriched ILEs and 81 patients (50.3%) on other ILEs. We found significant decreases in triglyceride levels in the fish oil group compared to the other patients. We did not find any differences in glucose metabolic control: mean capillary glucose, glycemic variability, and insulin dose, except in the number of mild hypoglycemic events that was significantly higher in the fish oil group. We did not observe any differences in other metabolic, liver or infectious complications, in-hospital length of stay or mortality

    Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial.

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    There is no established insulin regimen in T2DM patients receiving parenteral nutrition. To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN. Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle. 81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality. Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group. This trial is registered at clinicaltrials.gov as NCT02706119

    Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes : a systematic review and meta-analysis of randomised controlled trials

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    Background Digital health interventions have shown promising results for the management of type 2 diabetes, but a comparison of the effectiveness and implementation of the different modes is not currently available. Therefore, this study aimed to compare the effectiveness of SMS, smartphone application, and website-based interventions on improving glycaemia in adults with type 2 diabetes and report on their reach, uptake, and feasibility. Methods In this systematic review and meta-analysis, we searched CINAHL, Cochrane Central, Embase, MEDLINE, and PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) that examined the effectiveness of digital health interventions in reducing glycated haemoglobin A1c (HbA1c) in adults with type 2 diabetes, published in English from Jan 1, 2009. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint assessed was the change in the mean (and 95% CI) plasma concentration of HbA1c at 3 months or more. Cochrane risk of bias 2 was used to assess risk of bias. Data on reach, uptake, and feasibility were summarised narratively and data on HbA1c reduction were synthesised in a meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation criteria was used to evaluate the level of evidence. The study was registered with PROSPERO, CRD42021247845. Findings Of the 3236 records identified, 56 RCTs from 24 regions (n=11 486 participants), were included in the narrative synthesis, and 26 studies (n=4546 participants) in the meta-analysis. 20 studies used SMS as the primary mode of delivery of the digital health intervention, 25 used smartphone applications, and 11 implemented interventions via websites. Smartphone application interventions reported higher reach compared with SMS and website-based interventions, but website-based interventions reported higher uptake compared with SMS and smartphone application interventions. Effective interventions, in general, included people with greater severity of their condition at baseline (ie, higher HbA1c) and administration of a higher dose intensity of the intervention, such as more frequent use of smartphone applications. Overall, digital health intervention group participants had a –0·30 (95% CI –0·42 to –0·19) percentage point greater reduction in HbA1c, compared with control group participants. The difference in HbA1c reduction between groups was statistically significant when interventions were delivered through smartphone applications (–0·42% [–0·63 to –0·20]) and via SMS (–0·37% [–0·57 to –0·17]), but not when delivered via websites (–0·09% [–0·64 to 0·46]). Due to the considerable heterogeneity between included studies, the level of evidence was moderate overall. Interpretation Smartphone application and SMS interventions, but not website-based interventions, were associated with better glycaemic control. However, the studies' heterogeneity should be recognised. Considering that both smartphone application and SMS interventions are effective for diabetes management, clinicians should consider factors such as reach, uptake, patient preference, and context of the intervention when deciding on the mode of delivery of the intervention. Nine in ten people worldwide own a feature phone and can receive SMS and four in five people have access to a smartphone, with numerous smartphone applications being available for diabetes management. Clinicians should familiarise themselves with this modality of programme delivery and encourage people with type 2 diabetes to use evidence-based applications for improving their self-management of diabetes. Future research needs to describe in detail the mediators and moderators of the effectiveness and implementation of SMS and smartphone application interventions, such as the optimal dose, frequency, timing, user interface, and communication mode to both further improve their effectiveness and to increase their reach, uptake, and feasibility

    Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension : a systematic review and meta-analysis of randomised controlled trials

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    Background Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. Methods In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. Findings Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a –3·62 mm Hg (95% CI –5·22 to –2·02) greater reduction in systolic blood pressure, and a –2·45 mm Hg (–3·83 to –1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (–2·45 mm Hg [–4·15 to –0·74]); however, there were no statistically significant reductions for SMS interventions (–1·80 mm Hg [–4·60 to 1·00]) or website interventions (–3·43 mm Hg [–7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. Interpretation SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility
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