Alfonso Calle-Pascual

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 Telemedicine system based on Internet and short message service as a new approach in the follow-up of patients with gestational diabetes

To evaluate the feasibility of a Telemedicine system based on Internet and short message service in the follow-up of patients with gestational diabetes. Compared to control group, Telemedicine group reduced 62% the number of unscheduled face-to-face visits, and 82.7% in the subgroup of insulin-treated patients, improving patient satisfaction, and achieving similar pregnancy and new born outcomes.

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.

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.

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 <4 times/week, red and processed meats intake <6 servings/week, sugared drinks <4 servings/week, light walking >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.

Effects of intensive glucose control on platelet reactivity in patients with acute coronary syndromes. Results of the CHIPS Study ("Control de Hiperglucemia y Actividad Plaquetaria en Pacientes con Sindrome Coronario Agudo").

Objectives Hyperglycaemia has been associated with increased platelet reactivity and impaired prognosis in patients with acute coronary syndrome (ACS). Whether platelet reactivity can be reduced by lowering glucose in this setting is unknown. The aim of this study was to assess the functional impact of intensive glucose control with insulin on platelet reactivity in patients admitted with ACS and hyperglycaemia. Methods This is a prospective, randomised trial evaluating the effects of either intensive glucose control (target glucose 80–120 mg/dl) or conventional control (target glucose 180 mg/dl or less) with insulin on platelet reactivity in patients with ACS and hyperglycaemia. The primary endpoint was platelet aggregation following stimuli with 20 μM ADP at 24 h and at hospital discharge. Aggregation following collagen, epinephrine and thrombin receptor-activated peptide, as well as P2Y12 reactivity index and surface expression of glycoprotein IIb/IIIa and P-selectin were also measured. Results Of the 115 patients who underwent random assignment, 59 were assigned to intensive and 56 to conventional glucose control. Baseline platelet functions and inhospital management were similar in both groups. Maximal aggregation after ADP stimulation at hospital discharge was lower in the intensive group (47.9±13.2% vs 59.1±17.3%; p=0.002), whereas no differences were found at 24 h. Similarly all other parameters of platelet reactivity measured at hospital discharge were significantly reduced in the intensive glucose control group. Conclusions In this randomised trial, early intensive glucose control with insulin in patients with ACS presenting with hyperglycaemia was found to decrease platelet reactivity. Clinical Trial Registration Number http://www.controlledtrials.com/ISRCTN35708451/ISRCTN35708451.

Olive oil has a beneficial effect on impaired glucose regulation and other cardiometabolic risk factors. Di@bet.es study.

Background:Despite the marked increase in cardiovascular risk factors in Spain in recent years, the prevalence and incidence of cardiovascular diseases have not risen as expected. Our objective is to examine the association between consumption of olive oil and the presence of cardiometabolic risk factors in the context of a large study representative of the Spanish population.Subjects and methods:A population-based, cross-sectional, cluster sampling study was conducted. The target population was the whole Spanish population. A total of 4572 individuals aged ⩾18 years in 100 clusters (health centers) were randomly selected with a probability proportional to population size. The main outcome measures were clinical and demographic structured survey, lifestyle survey, physical examination (weight, height, body mass index, waist, hip and blood pressure) and oral glucose tolerance test (OGTT) (75 g).Results:Around 90% of the Spanish population use olive oil, at least for dressing, and slightly fewer for cooking or frying. The preference for olive oil is related to age, educational level, alcohol intake, body mass index and serum glucose, insulin and lipids. People who consume olive oil (vs sunflower oil) had a lower risk of obesity (odds ratio (OR)=0.62 (95% confidence interval (CI)=0.41–0.93, P=0.02)), impaired glucose regulation (OR=0.49 (95% CI=0.28–0.86, P=0.04)), hypertriglyceridemia (OR=0.53 (95% CI=0.33–0.84, P=0.03)) and low HDL cholesterol levels (OR=0.40 (95% CI=0.26–0.59, P=0.0001)).Conclusions:The results show that consumption of olive oil has a beneficial effect on different cardiovascular risk factors, particularly in the presence of obesity, impaired glucose tolerance or a sedentary lifestyle.

Mediterranean diet adherence in individuals with prediabetes and unknown diabetes: the Di@bet.es Study.

Background and Aims: Mediterranean diet (MedDiet) is causally related to diabetes and is a dietary pattern recommended to individuals with diabetes. We investigated MedDiet adherence in individuals with prediabetes and unknown (PREDM/UKDM) or known diabetes (KDM) compared to those with normal glucose metabolism (NORMAL). Methods: This was a national, population-based, cross-sectional, cluster-sampling study. MedDiet adherence was scored (MedScore, mean ± SD 24 ± 5) using a qualitative food frequency questionnaire. Logistic regression was used to examine the association between MedScore and PREDM/UKDM or KDM versus control subjects. Results: We evaluated 5,076 individuals. Mean age was 50 years, 57% were female, 826 (582/244) were PREDM/UKDM, 478 were KDM and 3,772 were NORMAL. Mean age increased across MedScore tertiles (46, 51 and 56 years, p < 0.0001). Higher age-adjusted adherence to MedDiet (5-unit increment in the MedScore) was associated with lower and nondifferent odds (OR, 95% CI) of prevalent PREDM/UKDM (0.88, 0.81-0.96, p = 0.001) and KDM (0.97, 0.87-1.07, p = 0.279), respectively, compared to individuals in the NORMAL group. Conclusions: In a representative sample of the whole Spanish population, MedDiet adherence is independently associated with PREDM/UKDM. Therapeutic intervention may be, in part, responsible for the lack of differences in adherence observed between the KDM and NORMAL groups. However, reverse causation bias cannot be ruled out in cross-sectional studies.

Initiation and gradual intensification of premixed insulin lispro therapy versus Basal {+/-} mealtime insulin in patients with type 2 diabetes eating light breakfasts.

OBJECTIVE We compared two strategies initiating and intensifying insulin treatment and tested for noninferiority of premixed insulin to basal ± mealtime insulin analog in patients eating light breakfasts. RESEARCH DESIGN AND METHODS This randomized, open-label, 48-week study compared two algorithms. Up to three injections of insulin lispro mix 25 and/or insulin lispro mix 50 (premix; premixed insulin lispro) or basal insulin glargine plus up to three injections of insulin lispro (basal+; glargine + insulin lispro) were used in type 2 diabetic patients uncontrolled with oral antihyperglycemic medication and consuming <15% daily calories at breakfast. The hypothesis was to test noninferiority of premix to basal+ for glycemic control measured by HbA1c after 48 weeks, assessed using ANCOVA with a 0.4% margin. RESULTS Patients (n = 344; 176 [51%] females; mean [SD] age 54.3 [8.8] years; BMI 29.4 [4.6] kg/m2; baseline HbA1c 9.02 [0.97]%) were randomized to premix (n = 171) or basal+ (n = 173). In the per-protocol analysis (n = 230), least squares means (95% CI) end point HbA1c were 7.40% (7.15–7.65) and 7.55% (7.27–7.82) in respective arms. Between-treatment difference was −0.14% (−0.42 to 0.13), with noninferiority met. Significantly more patients in premix achieved HbA1c targets of <7.0% compared with basal+ (48.2 vs. 36.2%; P = 0.024). Self-monitored blood glucose profiles, body weight changes, total insulin doses, and overall hypoglycemia (65 vs. 60%) were similar in premix and basal+ (P = 0.494), except nocturnal episodes (34.3 vs. 23.7%; P = 0.018) were more common in premix. CONCLUSIONS Both intensive insulin strategies improved glycemic control; however, final HbA1c levels were seen above those achieved in previous treat-to-target trials, likely due to the inadequate insulin titrations and probably due to the complexity of tested insulin regimens. A higher percentage of patients achieved target HbA1c <7% with multiple premixed insulins, but this treatment resulted in more nocturnal hypoglycemia than a basal–bolus regimen.