Alejandra Duran

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.

A preventative foot care programme for people with diabetes with different stages of neuropathy.

The aim of this study was to assess the efficacy of a preventative foot care programme, applied in a normal outpatient setting to decrease the incidence of foot ulcers in people with diabetes diagnosed as having neuropathy by neuropathy disability score (NDS), in relation to the severity of neuropathy based on the vibration perception threshold (VPT). A structured continuous preventative foot care programme was designed to ensure proper footwear, walking foot hygiene, callus care, nailcutting, water temperature checks, use of warming devices, bathroom surgery, foot care products and self-inspection. Continual foot-care education and treatment, including podiatry, were available. Evaluation was at least every 6 months. Diabetic patients (n=308) with neuropathy (NDS > or =6), 72.3+/-10.7 years old, 45% men, 10.9+/-8.8 years duration of diabetes, and HbA(1c) 6.5+/-1.3%, without a history of foot lesions were recruited over 3 years and followed-up for 4.6 (3-6) years. A low risk group (n=124) had a VPT<25 V while 184 had a VPT > or =25 V (high risk). In all 220 patients (71%) complied with the programme, compliance being 76 and 68% in low and high risk groups. The low risk group developed nine ulcers in nine patients, and the high risk group 24 ulcers in 19 patients. Of these eight and 19 ulcers, respectively, were in the non-compliant patient group, giving relative risk of 22 and eight compared with people attending the programme. Thus compliance with a preventative foot programme reduces the incidence of foot ulceration in people with diabetes with neuropathy. This decrease is relatively greater in patients with less severity of neuropathy. The simple design should be widely generalisable.

Comparison of peripheral arterial reconstruction in diabetic and non-diabetic patients : a prospective clinic-based study

UNLABELLED To assess the efficacy and safety of lower extremity arterial reconstruction in diabetic and non-diabetic subjects during a 3-year period. A prospective clinic-based study between 1994-1999 in Area 7, Madrid, with a population of 569307 and an estimated diabetic population of 37932 (15505 men and 22427 women). The level of arterial reconstruction and associated risk factors were ascertained. RESULTS A total of 588 peripheral revascularization surgical procedures were performed in 481 patients. The diabetic patients (n=174, 36.2%) underwent 222 surgical procedures (including 48 follow-on operations, 21.6%), and 307 non-diabetic subjects underwent 366 surgical procedures (59 follow-on operations, 16.1%). The numbers of surgical procedures per 100000 people at risk and year were 18.8 and 1.8 for non-diabetic men and women, respectively, and 145.1 and 29.0 for men and women with diabetes mellitus (7.7- and 16.2-fold, respectively). Age at reconstruction surgery was 2 and 5 years earlier in non-diabetic than in diabetic men and women, respectively. Diabetic patients had a higher neuropathy score (P<0.05) and were less frequently smokers (P<0.05) than non-diabetic subjects. Diabetic subjects more frequently had distal reconstruction while proximal arterial reconstruction was more often performed in non-diabetic subjects. Between 64.6 and 80.4% of people with diabetes and 82.3 and 88.9% of non-diabetic subjects had no complications during their in-hospital stay. Distal amputation simultaneous to arterial reconstruction was the most frequent morbidity of people with diabetes during the study (P<0.05). Despite a graft occlusion rate after femoropopliteal revascularization significantly higher than in non-diabetic people (P<0.05), diabetic people more often required lower extremity amputations (LEAs) for the same level of bypass (P<0.01). Cumulative limb salvage rates were lower in diabetic patients than in non-diabetic subjects at femoropopliteal (49.2 vs. 89.7%; P<0.001), femorodistal (73.5 vs. 95.2%; P<0.01), and distal reverse (77.9 vs. 87.3%; P<0.05) arterial reconstruction, at the end of the third year, but similar after aorto-iliac reconstruction (93.1 vs. 97.5%). A higher neuropathy score and the presence of foot ulcers were associated to significantly lower limb salvage in diabetic patients (P<0.05), but not in non-diabetic people. Survival rates after 3 years were similar between diabetic and non-diabetic populations after aorto-iliac (93.1 vs. 97.5%), femoropopliteal (97.2 vs. 90.3%), and distal reverse (93.2 vs. 98.1%) revascularization, and slightly lower in diabetic compared to non-diabetic patients after femorodistal revascularization (82.1 vs. 96.3%; P<0.05). CONCLUSION Although limb salvage after arterial reconstruction is lower in diabetic than in non-diabetic subjects, particularly in those with a higher neuropathy score, this surgical approach can be applied in both diabetic and non-diabetic subjects with otherwise similar outcome.

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.

Dietary Patterns and Weight Loss in New-onset Type 2 Diabetes Mellitus: A Sub-analysis of the St Carlos Study: A 3-year, Randomized, Clinic-based, Interventional Study

Objective: To assess lifestyle patterns associated with weight loss in newly-diagnosed type 2 diabetic patients (T2DM) in the St Carlos Study. Design: A 3-year, randomized, interventional study with three parallel groups. Setting: A single-center, outpatient clinic-based study. Participants: 195 newly-diagnosed T2DM were randomized to either the intervention group (self monitoring of blood glucose with-or-without an exercise program), or to the HbA1c control group. The same lifestyle-intervention protocol was applied in all patients.

Medical nutrition therapy for gestational diabetes mellitus based on Mediterranean Diet principles: a subanalysis of the St Carlos GDM Prevention Study

Objectives To assess whether Mediterranean Diet (MedDiet)-based medical nutrition therapy facilitates near-normoglycemia in women with gestational diabetes mellitus (GDMw) and observe the effects on adverse pregnancy outcomes. Research design and methods This is a secondary analysis of the St Carlos GDM Prevention Study, conducted between January and December 2015 in Hospital Clínico San Carlos (Madrid, Spain). One thousand consecutive women with normoglycemia were included before 12 gestational weeks (GWs), with 874 included in the final analysis. Of these, 177 women were diagnosed with gestational diabetes mellitus (GDM) and 697 had normal glucose tolerance. All GDMw received MedDiet-based medical nutrition therapy with a recommended daily extra virgin olive oil intake ≥40 mL and a daily handful of nuts. The primary goal was comparison of hemoglobin A1c (HbA1c) levels at 36–38 GWs in GDMw and women with normal glucose tolerance (NGTw). Results GDMw as compared with NGTw had higher HbA1c levels at 24–28 GWs (5.1%±0.3% (32±0.9 mmol/mol) vs 4.9%±0.3% (30±0.9 mmol/mol), p=0.001). At 36–38 GWs values were similar between the groups. Similarly, fasting serum insulin and homeostatic model assessment insulin resitance (HOMA-IR) were higher in GDMw at 24–28 GWs (p=0.001) but became similar at 36–38 GWs. 26.6% of GDMw required insulin for glycemic control. GDMw compared with NGTw had higher rates of insufficient weight gain (39.5% vs 22.0%, p=0.001), small for gestational age (6.8% vs 2.6%, p=0.009), and neonatal intensive care unit admission (5.6% vs 1.7%, p=0.006). The rates of macrosomia, large for gestational age, pregnancy-induced hypertensive disorders, prematurity and cesarean sections were comparable with NGTw. Conclusions Using a MedDiet-based medical nutrition therapy as part of GDM management is associated with achievement of near-normoglycemia, subsequently making most pregnancy outcomes similar to those of NGTw.