Isabelle Runkle

Introduction of IADPSG Criteria for the Screening and Diagnosis of Gestational Diabetes Mellitus Results in Improved Pregnancy Outcomes at a Lower Cost in a Large Cohort of Pregnant Women: The St. Carlos Gestational Diabetes Study

OBJECTIVE The use of the new International Association of the Diabetes and Pregnancy Study Groups criteria (IADPSGC) for the diagnosis of gestational diabetes mellitus (GDM) results in an increased prevalence of GDM. Whether their introduction improves pregnancy outcomes has yet to be established. We sought to evaluate the cost-effectiveness of one-step IADPSGC for screening and diagnosis of GDM compared with traditional two-step Carpenter-Coustan (CC) criteria. RESEARCH DESIGN AND METHODS GDM risk factors and pregnancy and newborn outcomes were prospectively assessed in 1,750 pregnant women from April 2011 to March 2012 using CC and in 1,526 pregnant women from April 2012 to March 2013 using IADPSGC between 24 and 28 weeks of gestation. Both groups received the same treatment and follow-up regimes. RESULTS The use of IADPSGC resulted in an important increase in GDM rate (35.5% vs. 10.6%) and an improvement in pregnancy outcomes, with a decrease in the rate of gestational hypertension (4.1 to 3.5%: −14.6%, P < 0.021), prematurity (6.4 to 5.7%: −10.9%, P < 0.039), cesarean section (25.4 to 19.7%: −23.9%, P < 0.002), small for gestational age (7.7 to 7.1%: −6.5%, P < 0.042), large for gestational age (4.6 to 3.7%: −20%, P < 0.004), Apgar 1-min score <7 (3.8 to 3.5%: −9%, P < 0.015), and admission to neonatal intensive care unit (8.2 to 6.2%: −24.4%, P < 0.001). Estimated cost savings was of €14,358.06 per 100 women evaluated using IADPSGC versus the group diagnosed using CC. CONCLUSIONS The application of the new IADPSGC was associated with a 3.5-fold increase in GDM prevalence in our study population, as well as significant improvements in pregnancy outcomes, and was cost-effective. Our results support their adoption.

Benefits of self‐monitoring blood glucose in the management of new‐onset Type 2 diabetes mellitus: The St Carlos Study, a prospective randomized clinic‐based interventional study with parallel groups

Background:  Intensive treatment of patients with Type 2 diabetes mellitus (T2DM) from the moment of diagnosis facilitates β‐cell recovery. Self‐monitoring of blood glucose (SMBG)‐based educational and pharmacological intervention may be better than conventional HbA1c algorithms in the treatment of newly diagnosed T2DM.

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.

Tratamiento de la hiponatremia secundaria al síndrome de secreción inadecuada de la hormona antidiurética: algoritmo multidisciplinar

INTRODUCTION The syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the most frequent cause of hyponatremia in a hospital setting. However, detailed protocols and algorithms for its management are lacking. Our objective was to develop 2 consensus algorithms for the therapy of hyponatremia due to SIADH in hospitalized patients. MATERIAL AND METHODS A multidisciplinary group made up of 2 endocrinologists, 2 nephrologists, 2 internists, and one hospital pharmacist held meetings over the period of a year. The group worked under the auspices of the European Hyponatremia Network and the corresponding Spanish medical societies. Therapeutic proposals were based on widely-accepted recommendations, expert opinion and consensus guidelines, as well as on the authors’ personal experience. RESULTS Two algorithms were developed. Algorithm 1 addresses acute correction of hyponatremia posing as a medical emergency, and is applicable to both severe euvolemic and hypovolemic hyponatremia. The mainstay of this algorithm is the iv use of 3% hypertonic saline solution. Specific infusion rates are proposed, as are steps to avoid or reverse overcorrection of serum sodium levels. Algorithm 2 is directed to the therapy of SIADH-induced mild or moderate, non-acute hyponatremia. It addresses when and how to use fluid restriction, solute, furosemide, and tolvaptan to achieve eunatremia in patients with SIADH. CONCLUSIONS Two complementary strategies were elaborated to treat SIADH-induced hyponatremia in an attempt to increase awareness of its importance, simplify its therapy, and improve prognosis.

Effect of lifestyle on the risk of gestational diabetes and obstetric outcomes in immigrant Hispanic women living in Spain

Background:  Data about the immigrant population living in Spain, their lifestyle habits, and risk factors for gestational diabetes mellitus (GDM) are limited. Thus, the aim of the present study was to describe risk factors for the onset of GDM, the evolution of gestation and delivery, and newborns of Hispanic women living in Spain compared with those of Spanish women.

Evaluation of Health-Related Quality of Life according to Carbohydrate Metabolism Status: A Spanish Population-Based Study (Di@bet.es Study)

Objective. To evaluate the association between diabetes mellitus and health-related quality of life (HRQOL) controlled for several sociodemographic and anthropometric variables, in a representative sample of the Spanish population. Methods. A population-based, cross-sectional, and cluster sampling study, with the entire Spanish population as the target population. Five thousand and forty-seven participants (2162/2885 men/women) answered the HRQOL short form 12-questionnaire (SF-12). The physical (PCS-12) and the mental component summary (MCS-12) scores were assessed. Subjects were divided into four groups according to carbohydrate metabolism status: normal, prediabetes, unknown diabetes (UNKDM), and known diabetes (KDM). Logistic regression analyses were conducted. Results. Mean PCS-12/MCS-12 values were 50.9 ± 8.5/ 47.6 ± 10.2, respectively. Men had higher scores than women in both PCS-12 (51.8 ± 7.2 versus 50.3 ± 9.2; P < 0.001) and MCS-12 (50.2 ± 8.5 versus 45.5 ± 10.8; P < 0.001). Increasing age and obesity were associated with a poorer PCS-12 score. In women lower PCS-12 and MCS-12 scores were associated with a higher level of glucose metabolism abnormality (prediabetes and diabetes), (P < 0.0001 for trend), but only the PCS-12 score was associated with altered glucose levels in men (P < 0.001 for trend). The Odds Ratio adjusted for age, body mass index (BMI) and educational level, for a PCS-12 score below the median was 1.62 (CI 95%: 1.2–2.19; P < 0.002) for men with KDM and 1.75 for women with KDM (CI 95%: 1.26–2.43; P < 0.001), respectively. Conclusion. Current study indicates that increasing levels of altered carbohydrate metabolism are accompanied by a trend towards decreasing quality of life, mainly in women, in a representative sample of Spanish population.

Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice.

BackgroundTo estimate the proportion of diabetic patients (DPts) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention, who meet ATP III and Steno targets of metabolic control, as well as to compare the outcome with the results of the patients treated by endocrinologists.MethodsA controlled, prospective over 30-months period study was conducted in area 7 of Madrid. One hundred twenty six eligible diabetic patients diagnosed as having peripheral vascular disease between January 2003 and June 2004 were included in the study. After a treatment period of three months by the Diabetes team at St Carlos Hospital, 63 patients were randomly assigned to continue their follow up by diabetes team (Group A) and other 63 to be treated by the family physicians (FP) at primary care level with continuous diabetes team coordination (Group B). 57 DPts from Group A and 59 from Group B, completed the 30 months follow-up period. At baseline both groups were similar in age, weight, time from diagnosis and metabolic control. The main outcomes of this study were the proportion of patients meeting ATP III and Steno goals for HbA1c (%), Cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, blood pressure, albumine-to-creatinine excretion ratio (ACR), body mass index (BMI), waist circumference (WC), anti-aggregation treatment and smoking status.ResultsAt the end of the follow up, no differences were found between the groups. More than 37% of diabetic patients assigned to be treated by FP achieved a HbA1c < 6.5%, more than 50% a ACR < 30 mg/g, and more than 80% reached low risk values for cholesterol, LDL cholesterol, triglycerides, diastolic blood pressure and were anti-aggregated, and 12% remained smokers. In contrast, less than 45% achieved a systolic blood pressure < 130 mm Hg, less than 12% had a BMI < 25 Kg.m-2 (versus 23% in group A; p < 0.05) and 49%/30% (men/women) had a waist circumference of low risk.ConclusionImprovements in metabolic control among diabetic patients with peripheral vascular disease treated at a primary health care setting is possible, reaching similar results to the patients treated at a specialized level. Despite such an improvement, body weight control remains more than poor in both levels, mainly at primary care level. General practitioner and endocrinologist coordination care may be important to enhance diabetes management in primary care settings.Trial registrationClinical Trial number ISRCTN75037597

A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study

Background Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied. Methods We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8–12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24–28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat. Results A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56–0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57–0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24–28 and 36–38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05). Conclusions An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes.

The impact of switching to the one-step method for GDM diagnosis on the rates of postpartum screening attendance and glucose disorder in women with prior GDM. The San Carlos Gestational Study

AIMS To compare rates of FPG-HbA1C-based postpartum-glucose disorder (PGD) of women with prior gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (CCc) versus International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGc). METHODS 1620 women with GDM were divided into CCc group (2007-March 2012, n=915), and IADPSGc group (April 2012-2013, n=705). Pregravid (PG) body weight (BW) and body mass index (BMI) and postdelivery (PD) BW, BMI, waist circumference (WC), HOMA-insulin resistance (HOMA-IR), HbA1c, glucose and lipid profile were analysed. PGD definition: HbA1c ≥5.7% and/or FPG ≥5.6mmol/l. RESULTS Postpartum screening attendance rates (PSAr) were similar in both groups, CCc: 791 (86.5%) and IADPSGc: 570 (81%) as in PGD rates (PGDr), CCc: 233 (29.5%) and IADPSGc: 184 (32.3%). Both cohorts had similar PG-BMI, WC and PD-BMI. Both CCc and IADPSGc women had a significantly higher probability of having PGD when PG-BMI ≥25Kg/m(2) (CCc: OR: 1.55; IC 95% 1.06-2.26; p=0.016), (IADPSGc: OR: 1.42; IC 95% 1.03-2.38; p=0.046) as well as when WC ≥89.5cm, and age ≥34years, and in CCc women when PD-WG >0Kg, all adjusted by ethnicity and parity. CONCLUSIONS Changing GDM diagnostic methodology did not affect PSAr and PGDr, in spite of screening more women. Thus, using IADPSGc allowed the identification of a larger number of women with PGD.

Gestational diabetes mellitus treatment reduces obesity-induced adverse pregnancy and neonatal outcomes: the St. Carlos gestational study

Background Obesity and gestational diabetes mellitus (GDM) increase the morbidity of the mother and newborn, which could increase further should they coexist. We aimed to determine the risk of adverse pregnancy and neonatal outcomes associated with excess weight (EW), and within this group identify potential differences between those with and without GDM. Methods We carried out a post-hoc analysis of the St. Carlos Gestational Study which included 3312 pregnant women, arranged in 3 groups: normal-weight women (NWw) (2398/72.4%), overweight women (OWw) (649/19.6%) and obese women (OBw) (265/8%). OWw and OBw were grouped as EW women (EWw). We analyzed variables related to adverse pregnancy and neonatal outcomes. Results The relative risk (95% CI) for GDM was 1.82 (1.47 to 2.25; p<0.0001) for OWw, and 3.26 (2.45 to 4.35; p<0.0001) in OBw. Univariate analysis showed associations of EW to higher rates of prematurity, birth weight >90th centile, newborns admitted to neonatal intensive care unit (NICU), instrumental delivery and cesarean delivery (all p<0.005). Multivariate analysis, adjusted for parity and ethnicity, showed that EW increased the risk of prematurity, admission to NICU, cesarean and instrumental delivery, especially in EWw without GDM. NWw with GDM had a significantly lower risk of admission to NICU and cesarean delivery, compared with NWw without GDM. Conclusions EW is detrimental for pregnancy and neonatal outcomes, and treatment of GDM contributes to lowering the risk in EWw and NWw. Applying the same lifestyle changes to all pregnant women, independent of their weight or GDM condition, could improve these outcomes.