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In the last 10 years tremendous progress has been made in the development of artificial pancreas (AP) systems for people with type 1 diabetes (T1D). The pan-European consortium CLOSE (Automated Glu cose Contro l at H ome for People with Chronic Disea se) is aiming to develop integrated AP solutions (APplus) tailored to the needs of people with type 2 diabetes (T2D). APplus comprises a product and service package complementing the AP system by obligatory training as well as home visits and telemedical consultations on demand. Outcome predictors and performance indicators shall help to identify people who could benefit most from AP usage and facilitate the measurement of AP impact in diabetes care. In a first step CLOSE will establish a scalable APplus model case working at the interface between patients, homecare service providers, and payers in France. CLOSE will then scale up APplus by pursuing geographic distribution, targeting additional audiences, and enhancing AP functionalities and interconnectedness. By being part of the European Institute of Innovation and Technology (EIT) Health public-private partnership, CLOSE is committed to the EIT "knowledge triangle" pursuing the integrated advancement of technology, education, and business creation. Putting stakeholders, education, and impact into the center of APplus advancement is considered key for achieving wide AP use in T2D care.

Introduction: Glycated hemoglobin (HbA1c) is used as a cumulative estimate of mean blood glucose levels from the preceding 5-12 weeks. This is the gold standard in assessing glycemic control in patients with diabetes. The ADA criteria for the diagnosis of diabetes, including HbA1c level, contribute to the importance of recognizing any variation pertaining to the HbA1c measurement. HbA1c is often used as a primary endpoint in the interventional studies among patients with diabetes. Thus, knowledge about factors independently to glycemia, affecting HbA1c is clinically useful., Aim of Study: Evaluation variability of fetal hemoglobin (HbF) level among Polish children with diabetes and how it may affect the HbA1c level measurement., Material and Methods: This was a prospective cohort study. A laboratory HbA1c testing was performed for more than 96% of pediatric diabetic patients in the region. In our study we included all consecutive patients aged 2 to 18 years with type 1 diabetes (T1D) and the disease duration longer than one year (555 patients). All patients had HbA1c and HbF measured at three time-points during minimum one-year period. In the same time, clinical data were recorded. The measurements of HbA1c and HbF were performed by means of cation-exchange high-pressure liquid chromatography (HPLC) on a D-10 Dual A2/F/A1c (Bio-Rad Laboratories, Hercules, CA, USA). Statistical analysis was performed using the Statistica 10.0 package (StatSoft, Tulsa, USA)., Results: An average age in the observed group was 12.9±3.8 years, diabetes duration 5.6±3.4 years, HbA1c was 7.59±1.33% (59±10.65 mmol/mol). In 78 (14%) patients elevated levels of HbF (>0.8%) were found at each time-point, mean value 1.2±0.45%. Elevated HbF was associated with younger age at examination (p=0.03) and younger age of diagnosis (p=0.01). It was not related to diabetes duration (p=0.21). No correlation between HbA1c and HbF was observed in the study (R=-0.09; p=0.43)., Conclusions: Fetal hemoglobin does not affect HbA1c measurement among pediatric patients with type 1 diabetes older that 2 years., (© Polish Society for Pediatric Endocrinology and Diabetology.)

Introduction: In the recent years there has been a significant increase in the incidence of the type 1 diabetes mellitus. Therefore, numerous studies are underway to evaluate the possible factors underlying this trend. Some studies suggest that better sanitary conditions and lack of contact with microorganisms might be important, thus increasing the risk of disease in firstborns. Moreover, siblings could play an important role in the transmission of pathogens, which, by stimulating the immune system, may prevent the development of atopic and autoimmune diseases including such as type 1 diabetes. Current data, however, are still inconclusive., Purpose: The aim of the study was to evaluate the effect of having siblings on the incidence of type 1 diabetes among children and adults., Materials and Methods: A group of 469 patients with type 1 diabetes was selected. The study population was composed of 245 adults and 224 youth patients. Information from Outpatient Diabetologic Departments database was gathered. Data such as age at the diagnosis of diabetes, sex of siblings, number and birth order were analyzed., Results: In the studied population, 4.5% were only children, and 30.3% patients came from large families. In the group of type 1 diabetic patients 39.7% were firstborns and this proportion was comparable to the group of healthy subject. The highest proportion of firstborns was noted in the group that was diagnosed after 18 years of age (45,1%) compared to the group that was diagnosed between 10 and 14 (29,1%) (p<0.05). Type 1 diabetic patients that were not firstborns much more often had older siblings of the opposite sex than the same sex., Conclusions: he firstborns in the population of type 1 diabetes from the Łódz region did not outnumber the healthy subjects. Significantly higher proportion of firstborns in the group that was diagnosed after 18 years of age compared to the group that was diagnosed between 10 an 14 years was noted., (© Polish Society for Pediatric Endocrinology and Diabetology.)

Introduction and Aim: Since insulin resistance is genetically determined and observed in type 1 diabetes, the study was designed to elucidate an involvement of Ala 12 Pro PPARg2 gene polymorphism in residual C-peptide secretion and BMI variation in children with type 1 diabetes., Material and Methods: In 103 patients with type 1 diabetes genetic analysis of PPARg2 polymorphism, C-peptide measurements and evaluation of BMI and clinical parameters were performed. Control group consisted of 109 healthy subjects., Results: In diabetic patients, only three individuals exhibited Ala 12 Ala genotype (2.9%) and 29 patients were heterozygous Ala 12 Pro (28.2%). Interestingly, Ala12+ variants were associated with higher C-peptide levels in 6 th , 12 th and 24 th months after the onset than Pro 12 Pro genotype (0.39±0.24 pmol/mL vs. 0.22±0.14 pmol/mL, P=0.007 and 0.19±0.09 vs. 0.11±0.07, P=0.01 and 0.13±0.09 vs. 0.07±0.05, P=0.021, respectively). Similarly, C-peptide was also significantly increased in patients with history of type 2 diabetes in the first-degree relatives. The observation was even more evident when Ala12+ variants were taken together with family history of type 2 diabetes. Besides, in 24 th and 36 th months after the onset, Ala12+ variants revealed to be associated with higher BMI normalized by age and sex as compared to Pro 12 Pro (0.557±0.84 vs. -0.119±0.73, P=0.001 and 0.589±0.919 vs. 0.066±0.630, P=0.016, respectively)., Conclusions: Thus, it is likely that PPARg2 gene polymorphism and/or the genetically determined insulin resistance may be associated with residual C-peptide secretion and involve excessive BMI in type 1 diabetes., (© Polish Society for Pediatric Endocrinology and Diabetology.)

Introduction: Despite the progress in diagnosis and treatment of type 1 diabetes, diabetic ketoacidosis (DKA) is still a serious clinical problem. The aim of the study was too describe the epidemiology and clinical characteristic of DKA in children and adolescents with type 1 diabetes., Material and Methods: Medical records of 650 patients with type 1 diabetes who were under care of the Outpatient Clinic for Diabetic Children of the Medical University of Lodz from 1st January 2007 till 31 December 2009 were analysed., Results: 101 cases of DKA were reported; the incidence of DKA was 5.2/100 patients /year. Episodes of DKA occurred in 89 patients (39 girls and 50 boys). In 82 patients 1 episode of DKA was recorded, in 3 patients - 2 episodes, in 3 patients - 3 episodes and in 1 patient - 4 episodes. 58.4% (59/101) of DKA episodes occurred in patients with newly diagnosed diabetes (mean age: 8.04-4.78 years) and 41.6% (42/101) - in children with established type 1 diabetes (mean age: 13.3-3.37). DKA was diagnosed in 26,1% of children with new onset of the disease. The most frequent causes of DKA in patients with established type 1 diabetes were noncompliance (22/42) and acute infectious diseases (12/42). Severe DKA was diagnosed in 19/101 episodes, moderate - in 36/101 and mild - in 46/101. No lethal complication of DKA was recorded. The following complications of DKA were observed: dyselectrolitemia (68/101), acute pancreatitis (5/101), gastrorrhagia (1/101), insulin oedema (1/101). Mean duration of hospitalization was 12.03-5.58 days., Conclusions: Newly diagnosed type 1 diabetes is the main cause of DKA in children and adolescents.In established type 1 diabetes the most frequent cause of DKA is poor quality of self-management. Dyselectrolitemia is the most frequent complication of DKA in children. Acute pancreatitis should be considered in a young patient with DKA.

Introduction: Glycated haemoglobin is currently a golden standard of evaluation of metabolic control of diabetes. According to the Evidence based Medicine data, better metabolic control of diabetes decreases the prevalence of chronic complications., Aim of the Study: to analyse HbA1c in children with a longer duration of type 1 diabetes mellitus (t1DM)., Material and Methods: We analysed an epidemiological database (2006-2009) of 7783 HbA1c values of 996 children (465 girls) with t1DM treated at three academic centres (Gdańsk, Łódź, Katowice) in Poland. the mean age was 13.04±3.43 years and the mean duration of diabetes was 6.93±2.33 years., Results: the overall mean HbA1c was 7.6±1.5% (by age groups: 7.0±0.8%, 2-5 yrs; 7.1±1.0%, 6-10 yrs; 7.8±1.7%, 11-19 yrs) without gender-related differences. HbA1c increased significantly with increasing age and t1DM duration. HbA1c values differed significantly between the centres. A group of 455 (55.7%) children reached a stable course of diabetes with HbA1c <7.5%, and 110 (13.5%) had HbA1c levels >9%. The mean HbA1c ?6.5% was found in 150 children (18.4%)., Conclusions: In more than 50% of Polish children with longer t1DM duration, the international target of glycaemic control (HbA1c) is achieved; however, only 18% of them reached Polish national target. Age, t1DM duration and centre-specific factors influence the HbA1c values.

Introduction: The glycated A1c hemoglobin (HbA(1)c) is an accepted marker of glycemic control in patients with type 1 diabetes (T1DM) and a predictor of long-term microvascular diabetic complications. There have been reports of seasonal fluctuations of HbA(1)c levels in type 1 and type 2 diabetic patients of different age., Aim of the Study: The aim of the study was to investigate retrospectively investigate seasonal variations of HbA(1)c levels in a pediatric population of T1DM patients over a one-year period., Materials and Methods: The study group included 473 patients aged 2.4 -18 years (mean 13.3 ± 3.7) with T1DM duration of at least 6 months in whom HbA(1) c levels were tested between November 1, 2008 and October 31, 2009. HbA(1)c was measured by high performance liquid chromatography (HPLC)., Results: The total number of 1417 HbA(1)c tests were performed (mean 3.0 tests/patient/year). Mean HbA(1)c level was (mean ± SD) 7.7 ± 1.5% (range 5.2 -15.7%; median 7.4%; 25-75% range: 6.7 -8.2%). Statistically significant differences in monthly HbA(1)c levels were found (analysis of variance; p < 0.001). The lowest HbA(1)c levels, observed in August and September, were significantly lower than in February, March, April and December. Relative HbA(1)c levels, expressed as percentages of individual patient's mean value for twelve months, showed similar seasonal fluctuations: the lowest values were observed in August and September and the highest were noted in February, March, April, November and December., Conclusions: 1. HbA(1)c levels in young T1DM patients show seasonal variability. 2. Considering seasonal HbA(1)c fluctuations in patients education and management schedules could improve glycemic control. 3. Seasonal changes of HbA(1)c levels should be considered in short-term(lasting several months) clinical study designs.

Introduction: Due to the lack of precise diagnostic criteria, current search strategy for monogenic diabetes is predominantly based on atypical clinical course of diabetes and intuition of the attending physician. Yet another issue is the common view that monogenic diabetes is rare. It discourages from performing deepened diagnostics and makes it difficult to gain experience necessary to select appropriate patients for genetic examination., Aim of the Study: Estimating the true incidence of patients with a high probability of monogenic background of the disease and compare their search strategies based on clinical practice or structured databases., Material and Methods: The authors compared the current strategy of selecting candidates for screening with a directed search strategy based on immunologic (lack of islet autoantibodies), functional (presence or complete lack of c-peptide at onset and follow-up) and familial (dominant pattern of inheritance) criteria. The number of patients selected for the screening was chosen as efficacy measure selected among 1281 diabetic patients diagnosed and treated between 1983-2009., Results: Screening based on clinical assessment yielded 37 patients (2.9%) chosen for genetic screening. Criteria used by the physicians were based on up-to-date guidelines and unusual clinical course. Active search of the database according to predefined criteria resulted in selecting: 121 patients (9.4%) with likely monogenic background of diabetes (71 - lack of autoantibodies, 8 - normal C-peptide, 6 - lack of both c-peptide and autoantibodies, 36 - diabetes in at least one parent). The difference in screening efficacy was statistically significant (p <0.0001)., Conclusions: Periodic reevaluation of patients' data allows a significant increase in the number of candidates subjected to genetic screening and potentially achieving beneficial therapeutic effects by means of pharmacogenetics.

The Aim of the Study: was to estimate the relationship between serum leptin levels and insulin sensitivity and components of metabolic syndrome in type 1 diabetic children and adolescents., Materials and Methods: 158 patients with type 1 diabetes mellitus (70 girls and 88 boys) aged from 8.2 to 18.4 years (mean: 14.1+/-3.1 years) were included into the study. The diabetes duration ranged from 1.6 to 14.7 years (mean: 3.8+/-2.5 years). The height, weight, waist circumference (WC), skin folds and blood pressure were measured. Body mass index (BMI-SDS), body fat (BF) according to Slaughter formula, and daily dose of insulin were calculated. HbA1c (HPLC method) and serum lipids (enzymatic method) concentrations were examined. Serum leptin concentration was measured by ELISA method. Euglycemic-hyperinsulinemic clamp was performed to estimate insulin resistance. Glucose disposal rate (M index) determined during the last 30 min of the test was calculated as a surrogate of insulin resistance., Results: Serum leptin levels ranged from 1.47 to 57.39 ng/ml (median [quartiles]: 4.60 [3.18-10.2]). M index was 2.10-15.19 mg/kg/min. (median [quartiles]: 7.04 [5.57-8.69]. Leptin was positively correlated with BMI-SDS, WC, skin folds and BF. During puberty leptin levels increased in girls, but in boys the highest levels were observed at Tanner stage 3. Leptin concentrations, normalized for BMI-SDS or BF, were significantly higher in females than in males at Tanner stages 4 (pc=0.047) and 5 (pc<0.001). Leptin was negatively correlated with M index (r=-0.26; p=0.001 adjusted for sex and puberty), but after adjusting for BF or BMI-SDS there were no significant correlations. Leptin was not significantly associated with HDL-cholesterol, SBP and DBP. Using the multivariate linear regression models, we found that plasma leptin remained significantly associated with TG., Conclusion: It is likely that the observed relationship between leptin concentration and insulin resistance in young patients with type 1 diabetes is due to body fat composition rather than represents an independent association in this group.

Aim: Higher blood pressure is a marker of increased risk for development of diabetic angiopathy. The aim of the study was to evaluate the selected factors influencing the prevalence of prehypertension in T1DM children and adolescents., Methodology: 113 T1DM patients (62 male), aged 12-19 years, with diabetes duration from 0.5 to 17.3 years, without evidence of arterial hypertension during routine examination were recruited. In patients 24-hour automatic blood pressure (BP) monitoring was performed. Prehypertension was diagnosed SBP>120 mmHg and < 95pc and/or DBP>80 mmHg and < 95pc. Among metabolic factors body mass index (BMI), lipids profile, HbA1c and insulin sensitivity index glucose disposal rate (euglycemic hiperinsulinemic clamp) were estimated. As an early marker of autonomic neuropathy heart rate variation was measured., Results: None of the study patients had hypertension. In 35 individuals (31%) prehypertension was diagnosed. The prehypertension group had older age (17.4 vs. 15.8 years, p<0.001), longer duration of disease (6.6 vs. 4.3 years, p=0.003), greater BMI (23.8 vs. 22.0 kg/m2, p=0.01) and lower insulin sensitivity index (5.9 vs. 7.0 mg/kg/min., p=0.04) as compared with the group with normal value of blood pressure. There were no differences between groups in lipids profile and HbA1c. In the patients with prehypertension the greater activity of sympathetic activation was observed (LF/HF--1. 0 vs. 0.82, p=0.02)., Conclusions: Prehypertension is common feature in children and adolescents with type 1 diabetes. The prevalence of prehypertension is associated with older age, longer duration of disease, greater BMI, lower insulin sensitivity and the shift of the sympathovagal balance toward sympathetic activation.

Background: The elevated blood pressure is one of the most important risk factors of diabetic micro- and macroangiopathy., Aim of the Study: Evaluation of the prevalence of prehypertension and relationship between prehypertension, metabolic control and chronic complications in children and adolescents with type 1 diabetes mellitus., Materials and Methods: 83 patients aged 12.0-18.9 years, with a duration of diabetes 0.5-17.3 years, without evidence of arterial hypertension were recruited. In all patients 24-hour automatic blood pressure monitoring was performed with oscillometric device. The individuals with >40% of systolic and/or diastolic blood pressure >120/80 mmHg were defined as prehypertensive. HbA(1)c was measured by HPLC, plasma lipid levels--by an enzymatic method and urinary albumin excretion rate by chemiluminescent enzyme immunoassay method. Body mass index (BMI) and daily dose of insulin were calculated. Ophthalmoscopic examination and power spectral analysis of heart rate variation were performed., Results: In 30 individuals (36.1%) prehypertension was diagnosed. The prehypertension group had older age (17.5+/-1.1 vs. 15.9+/-2.3 years; p<0.001) and longer duration of the disease (7.3+/-4.7 vs. 4.7+/-3.4 years; p=0.005) as compared with the group with normal blood pressure. There were no significant differences between groups in HbA1c, daily dose of insulin, BMI-SDS, lipids profile, prevalence of microalbuminuria and retinopathy. In the patients with prehypertension the a greater activity of sympathetic activation was observed (LF/HF: 1.00+/-0.06 vs. 0.78+/-0.04, p=0.018)., Conclusions: Prehypertension is frequently recognized in type 1 diabetic children and adolescents. The prevalence of prehypertension is associated with older age, longer duration of diabetes and the shift of the sympatho-vagal balance toward sympathetic activation. There is no relationship between prehypertension and metabolic control or the prevalence of microvascular complications.

Background and Aim of the Study: Our own studies confirm the hypothesis, that insulin resistance of various degree is often observed in children and adolescents with type 1 diabetes mellitus (T1DM). The knowledge of this parameter characterizing individual patients may be of great value not only for better understanding of the disease course but also as a potential source of specific treatment. Reliable estimation of insulin resistance with hyperinsulinemic euglycemic clamp is a complex, laborious and costly procedure. These facts were enough to motivate us to make an attempt to elaborate an indirect, simplified method of insulin resistance assessment in T1DM children, that would be based on patients characteristics and on clinical parameters of the disease course., Materials and Methods: 142 children and adolescents with T1DM (79 boys, 63 girls) aged 7.7-20.3 years (mean age - 13.7+/-3.3 years) were included into the study. Duration of diabetes was 0.5-12.5 years (mean 2.7+/-2.3 years). The stage of puberty was assessed by the Tanner scale. Euglycemic-hyperinsulinemic clamp by de Fronzo was performed to estimate insulin resistance. Glucose disposal rate (M index) determined during the last 30 min of the test estimated insulin resistance. Looking for clinical and metabolic factors characterizing insulin resistance: a) the plasma cholesterol, HDL-Ch, triglycerides and HbA1c were examined, b) the height, weight, waist circumference and blood pressure were measured, c) body mass index and daily dose of insulin were calculated. For statistical analysis the multiple regression was used (forward stepwise method)., Results: In the study group M index ranged from 2.1 to 17.4 mg/kg/min (mean 7.27+/-2.62 mg/kg/min). The boys presented better insulin sensitivity than girls (7.79 vs. 6.62, p=0.008). The insulin resistance depended on the patients' age (r=-0.46, p<0.001) and stage of puberty (p<0.001). A correlation between M index and insulin dose (r=-0.34, p<0.05) and HbA1c (r=-0.17; p=0.04) were found. There was a significant relationship between M index and parameters of adiposity, lipids and blood pressure. All significant clinical parameters of insulin resistance were subjected to the analysis. Multiple linear regression analysis was performed. The model with the strongest correlation with index M was used to work out the formula: M index = 17.065 + 1.547 x (gender: boys=1, girls=0) - 0,183 x (age) - 0,117 x (Waist circumference) - 2,019 x (Daily insulin dose) - 0,016 x (LDL-CH) + 0,041 x (DBP)., Conclusion: In T1DM children and adolescents it is possible to estimate for daily use extent of insulin resistance on the basis of clinical features.

Unlabelled: Severe hypoglycemia may limit the effects of type 1 diabetes treatment. Insulin antibodies were mentioned to be included in the pathogenesis of hypoglycemia in adult diabetic patients, particularly those treated with non-human insulins. The influence of insulin antibodies on the occurrence of hypoglycemia in children treated with human insulin was not studied. THE AIM of the study was to examine insulin antibodies titers in young type 1 diabetics with a recent history of severe hypoglycemia and in matched control subjects., Materials and Methods: Insulin antibodies (IA) were assessed in 33 type 1 diabetic children (mean age 13.2, quartile interval 10.3-16.4) within 14 days after an episode of severe hypoglycemia. In 30 patients from this group, whose serum samples were collected also in the last two years preceding the episode of severe hypoglycemia and stored for routine immunologic assessment, IA levels before severe hypoglycemia were assessed, too. The control group consisted of 30 type 1 diabetic patients (mean age 14.4, quartile interval 12.7-15.4), who never experienced any severe hypoglycemia episode, and matched the study group for sex, age and diabetes duration. All patients were treated either with human insulin or with human insulin analogue lispro and NPH human insulin. Insulin antibodies were determined semi-quantitatively (as serum capacity to bind 125I-insulin) by radioimmunoassay., Results: Compared to controls (median value 19.5%, quartile interval 13.7-30.1%), patients who experienced severe hypoglycemia had higher IA levels after (mean value 30.6%, quartile interval 16.8-39.1%, p<0.04) as well as before hypoglycemia (mean value: 35.9, quartile interval 21.6-46.8%, p<0.02). There was a strong correlation between IA levels measured before and after severe hypoglycemia episodes (r=0.7, p<0.0001) in the study group., Conclusions: High insulin antibodies levels may be markers of increased risk for severe hypoglycemia acting in a mechanism other than a simple imbalance between exogenous insulin, carbohydrate consumption and physical exercise.