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

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

The Outcomes of Gestational Diabetes Mellitus after a Telecare Approach Are Not Inferior to Traditional Outpatient Clinic Visits

Objective. To evaluate the feasibility of a telemedicine system based on Internet and a short message service in pregnancy and its influence on delivery and neonatal outcomes of women with gestational diabetes mellitus (GDM). Methods. 100 women diagnosed of GDM were randomized into two parallel groups, a control group based on traditional face-to-face outpatient clinic visits and an intervention group, which was provided with a Telemedicine system for the transmission of capillary glucose data and short text messages with weekly professional feedback. 97 women completed the study (48/49, resp.). Main Outcomes Measured. The percentage of women achieving HbA1c values <5.8%, normal vaginal delivery and having a large for-gestational-age newborn were evaluated. Results. Despite a significant reduction in outpatient clinic visits in the experimental group, particularly in insulin-treated women (2.4 versus 4.6 hours per insulin-treated woman resp.; P < .001), no significant differences were found between the experimental and traditional groups regarding HbA1c levels (all women had HbA1c <5.8% during pregnancy), normal vaginal delivery (40.8% versus 54.2%, resp.; P > .05) and large-for-gestational-age newborns (6.1% versus 8.3%, resp.; P > .05). Conclusions. The system significantly reduces the need for outpatient clinic visits and achieves similar pregnancy, delivery, and newborn outcomes

Risk Factors for Gestational Diabetes Mellitus in a Large Population of Women Living in Spain: Implications for Preventative Strategies

The aim of this study is to establish a risk appraisal model for GDM by identifying modifiable factors that can help predict the risk of GDM in a large population of 2194 women living in Spain. They were recruited between 2009-2010 when screening for GDM was performed. Participants completed a questionnaire on socio-demographic, anthropomorphic and behavioral characteristics, and reproductive and medical history. A total of 213 (9.7%) women were diagnosed as having GDM. Age, pregestational body weight (BW) and body mass index (BMI), and number of events of medical, obstetric and family history were significantly associated with GDM. After logistic regression model, biscuits and pastries intake 30 minutes/day, and 30 minutes/day of sports at least 2 days/week, compared with opposite consumption, was associated with less GDM risk. Our study identified several pregestational modifiable lifestyle risk factors associated with an increase in the risk of developing GDM. This may represent a promising approach for the prevention of GDM and subsequent complications. Further intervention studies are needed to evaluate if this appraisal model of risk calculation can be useful for prevention and treatment of GDM

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

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

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

The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study

Objective: This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus. Research Design and Methods: This 6-month prospective, randomized, comparative, open, multicenter study included patients with type 1 diabetes >18 years old treated with multiple insulin doses and with a glycated hemoglobin (HbA1c) level of >8%. We compared an intervention group (IG) (two face-to-face and five telematic appointments) with a control group (CG) (seven face-to-face appointments). The variables studied were (1) patient and healthcare team costs, (2) metabolic control, (3) knowledge of diabetes, (4) quality of life, and (5) self-care treatment adherence. Results: Of the 154 patients included, 118 (76.6%) completed the study (IG, 54; CG, 64). The time used by the CG to follow the program was 823±645 min versus 353±222 min in the IG (P<0.0001). Compared with the CG, the IG required less healthcare time from the professionals (288±105 min vs. 232±89 min; P<0.001). HbA1c improved in both groups (IG, 9.2±1.5% [77.0±17.0 mmol/mol] vs. 8.7±1.5% [71.6±17.0 mmol/mol] [P<0.001]; CG, 9.2±0.9% [77.0±10.0 mmol/mol] vs. 8.6±0.9% [70.5±10.0 mmol/mol] [P<0.001], as did knowledge and self-care treatment adherence. Conclusions: The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy, providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control, knowledge acquisition, and self-care treatment adherence, with a significant reduction in the time used, especially by patients

The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study

Objective: This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus. Research Design and Methods: This 6-month prospective, randomized, comparative, open, multicenter study included patients with type 1 diabetes >18 years old treated with multiple insulin doses and with a glycated hemoglobin (HbA1c) level of >8%. We compared an intervention group (IG) (two face-to-face and five telematic appointments) with a control group (CG) (seven face-to-face appointments). The variables studied were (1) patient and healthcare team costs, (2) metabolic control, (3) knowledge of diabetes, (4) quality of life, and (5) self-care treatment adherence. Results: Of the 154 patients included, 118 (76.6%) completed the study (IG, 54; CG, 64). The time used by the CG to follow the program was 823±645 min versus 353±222 min in the IG (P<0.0001). Compared with the CG, the IG required less healthcare time from the professionals (288±105 min vs. 232±89 min; P<0.001). HbA1c improved in both groups (IG, 9.2±1.5% [77.0±17.0 mmol/mol] vs. 8.7±1.5% [71.6±17.0 mmol/mol] [P<0.001]; CG, 9.2±0.9% [77.0±10.0 mmol/mol] vs. 8.6±0.9% [70.5±10.0 mmol/mol] [P<0.001], as did knowledge and self-care treatment adherence. Conclusions: The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy, providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control, knowledge acquisition, and self-care treatment adherence, with a significant reduction in the time used, especially by patients

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

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