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IntroductionThe gut microbiota may be relevant in the development of type 1 diabetes (T1D). We examined the effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed T1D.Research design and methodsChildren aged 8–17 years with newly (within 60 days) diagnosed T1D were enrolled in a double-blind, randomised controlled trial in which they received L. rhamnosus GG and B. lactis Bb12 at a dose of 109 colony-forming units or placebo, orally, once daily, for 6 months. The follow-up was for 12 months. The primary outcome measure was the area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal.ResultsNinety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years). Eighty-eight (92%) completed the 6-month intervention, and 87 (91%) completed the follow-up at 12 months. There was no significant difference between the study groups for the AUC of the C-peptide level. For the secondary outcomes at 6 months, there were no differences between the study groups. At 12 months, with one exception, there also were no significant differences between the groups. Compared with the placebo group, there was a significantly increased number of subjects with thyroid autoimmunity in the probiotic group. However, at baseline, there was also a higher frequency of thyroid autoimmunity in the probiotic group. There were no cases of severe hypoglycemia or ketoacidosis in any of the groups. No adverse events related to the study products were reported.ConclusionsL. rhamnosus GG and B. lactis Bb12, as administered in this study, had no significant effect in maintaining the residual pancreatic beta-cell function in children with newly diagnosed T1D. It remains unclear which probiotics, if any, alone or in combination, are potentially the most useful for management of T1D.Trial registration numberNCT03032354.

IntroductionThe Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of Bifidobacterium infantis from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.Methods and analysisInfants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of B. infantis EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin.Ethics and disseminationThe study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study.Trial registration numberNCT04769037.

Aims The level of C-peptide can identify individuals most likely to respond to immune interventions carried out to prevent pancreatic β-cell damage. The aim of the study was to evaluate factors associated with C-peptide levels at type 1 diabetes (T1D) diagnosis. Methods This study included 1098 children aged 2-17 with newly recognized T1D. Data were collected from seven Polish hospitals. The following variables were analyzed: date of birth, fasting C-peptide, HbA1c, sex, weight, height, pH at diabetes onset. Results A correlation was observed between fasting C-peptide level and BMI-SDS (p = 0.0001), age (p = 0.0001), and HbA1c (p = 0.0001). The logistic regression model revealed that fasting C-peptide ≥0.7 ng/ml at diabetes diagnosis was dependent on weight, HbA1c, pH and sex (p Overweight and obese children (n = 124) had higher fasting C-peptide (p = 0.0001) and lower HbA1c (p = 0.0008) levels than other subjects. Girls had higher fasting C-peptide (p = 0.036) and higher HbA1c (p = 0.026) levels than boys. Conclusion Obese and overweight children are diagnosed with diabetes at an early stage with largely preserved C-peptide levels. Increased awareness of T1D symptoms as well as improved screening and diagnostic tools are important to preserve C-peptide levels. There are noticeable gender differences in the course of diabetes already at T1D diagnosis.

We present the course of the insulin therapy during total parenteral nutrition (TPN) after gastroscopy complicated by duodenal intramural haematoma, in a boy with type 1 diabetes treated with the insulin pump. There is a lack of guidelines regarding the insulin therapy during TPN in children. Additionally, duodenal intramural haematoma is a very rare complication of diagnostic gastroscopy. There are only few cases reported so far.Przedstawiamy przebieg insulinoterapii w trakcie całkowitego żywienia parenteralnego zastosowanego u chłopca z cukrzycą typu 1, leczonego osobistą pompą insulinową (OPI), u którego doszło do powstania śródściennego krwiaka dwunastnicy (ŚKD) jako powikłania diagnostycznej gastroskopii. W dotychczasowych opracowaniach brak jest wytycznych co do terapii insuliną w żywieniu pozajelitowym u dzieci. Dodatkowo ŚKD to bardzo rzadkie powikłanie endoskopii górnego odcinka przewodu pokarmowego. Do tej pory opisano w literaturze nieliczne przypadki.

Introduction Recent evidence has demonstrated that, among other factors, dysbiosis (imbalances in the composition and function of the gut microbiota) may be relevant in the development of type 1 diabetes (T1D). Thus, gut microbiota may be a target for improving outcomes in subjects with T1D. The aim of the study is to examine the effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed T1D. Methods and analysis A total of 96 children aged 8 to 17 years with newly diagnosed T1D, confirmed by clinical history and the presence of at least one positive autoantibody, will be enrolled in a double-blind, randomised, placebo-controlled trial in which they will receive L. rhamnosus GG and B. lactis Bb12 at a dose of 109 colony-forming units or an identically appearing placebo, orally, once daily, for 6 months. The follow-up will be for 12 months. The primary outcome measures will be the area under the curve of the C-peptide level during 2-hour responses to a mixed meal. Ethics and dissemination The Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences. Trial registration number NCT03032354; Pre-results.

The aim: The aim of this study is to analyze changes in the basal insulin requirement in preschoolers treated with insulin pump at the onset of T1DM, using system to calculate meal time insulin. Methods: 58 children (31 girls) under 6 years (mean age 3.3 ± 1.5 years) initiated on insulin pump therapy within 2 months after recognition of T1DM and treated at least for 1 year were analyzed during a follow-up period of 165 patient-years. Data was collected every 6 months: HbA1c, BMI SDS, diabetic ketoacidosis, severe hypoglycaemia, total daily insulin dose (TDD) and basal insulin. Results: Basal insulin rose from 10% in the third month and did not exceed 30% of TDD after 12 months (p

We investigated the potential effects of the Continuous Glucose Monitoring System (CGMS), as compared with self-monitoring of blood glucose, on glycaemic control in children with type 1 diabetes.The following electronic databases were searched throughout June 2007: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from reviewed articles. Only randomised controlled trials were included.We included five trials involving 131 type 1 diabetic patients in the study. Combined data from all trials showed that the CGMS did not significantly reduce HbA1c levels compared with control groups. The pooled weighted mean difference was -0.02% (95% CI -0.29 to 0.25) with a fixed model and remained insignificant in the random effect model. Sensitivity analysis determined that the findings were stable. There was a trend towards a longer time under the CGMS curve for glucose3.89 mmol/l in the CGMS group compared with the control group (mean difference 49.00 min, 95% CI -18.00 to 116.00). The CGMS significantly increased the number of insulin dose changes per patient per month for those managed with CGMS compared with the control groups (mean difference 6.3 changes, 95% CI 2.88-9.72).The Continuous Glucose Monitoring System is not better than self-monitoring of blood glucose with regard to improvement of metabolic control among type 1 diabetic children. However, due to the small number of participants and methodological limitations of the studies included, findings of this meta-analysis should be interpreted with caution.

IntroductionRecent evidence has demonstrated that, among other factors, dysbiosis (imbalances in the composition and function of the gut microbiota) may be relevant in the development of type 1 diabetes (T1D). Thus, gut microbiota may be a target for improving outcomes in subjects with T1D. The aim of the study is to examine the effects ofLactobacillus rhamnosusGG andBifidobacterium lactisBb12 on beta-cell function in children with newly diagnosed T1D.Methods and analysisA total of 96 children aged 8 to 17 years with newly diagnosed T1D, confirmed by clinical history and the presence of at least one positive autoantibody, will be enrolled in a double-blind, randomised, placebo-controlled trial in which they will receiveL. rhamnosusGG andB. lactisBb12 at a dose of 109colony-forming units or an identically appearing placebo, orally, once daily, for 6 months. The follow-up will be for 12 months. The primary outcome measures will be the area under the curve of the C-peptide level during 2-hour responses to a mixed meal.Ethics and disseminationThe Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences.Trial registration numberNCT03032354; Pre-results.

Background: The aim of the study was to assess whether an Insulin-Carbohydrate Ratio (ICR) increased by 30% per meal with a high glycaemic load allows postprandial glucose excursion to be maintained in control in children with type 1 diabetes. Methods: A total of 70 children on insulin pump therapy participated in the study. They were stratified into age groups: 4-7 years of age, 8-12 years of age and above 12 years of age. The experimental Group (A) received an insulin dose based on individualised ICR increased by 30% for breakfast containing cornflakes with milk. The control group (B) received an insulin dose based on standard individualised ICR. The glycaemic load of the meal was adjusted to the age group (24,3; 32,4; 40,5). We assessed metabolic effects such as the area under the glucose curve (AUC), glucose increment, risk of hyperglycaemia and hypoglycaemia using two methods: blood glucose concentration (at 0, 15, 30, 45, 60, 90 and 120 minutes) and a continuous subcutaneous glucose measurement system (for 3 hours postprandially). Results: A significant glucose rise was noted in the control group B (p=0.03). Over the postprandial 180 minutes, AUC was significantly lower (p=0.02) in the experimental group but only in children aged 8-12. The frequency of hypoglycaemic events was not statistically significant during postprandial observation (p=0.75). Conclusion: Increasing the ICR by 30% for a meal with high GL can reduce the glucose excursion without increasing the risk of hypoglycaemia in children with type 1 diabetes treated with insulin pump therapy.

Our study examines the hypothesis that in addition to sugar starch-type diet, a fat-protein meal elevates postprandial glycemia as well, and it should be included in calculated prandial insulin dose accordingly. The goal was to determine the impact of the inclusion of fat-protein nutrients in the general algorithm for the mealtime insulin dose calculator on 6-h postprandial glycemia.Of 26 screened type 1 diabetes patients using an insulin pump, 24 were randomly assigned to an experimental Group A and to a control Group B. Group A received dual-wave insulin boluses for their pizza dinner, consisting of 45 g/180 kcal of carbohydrates and 400 kcal from fat-protein where the insulin dose was calculated using the following algorithm: n Carbohydrate Units×ICR+n Fat-Protein Units×ICR/6 h (standard+extended insulin boluses), where ICR represents the insulin-to-carbohydrate ratio. For the control Group B, the algorithm used was n Carbohydrate Units×ICR. The glucose, C-peptide, and glucagon concentrations were evaluated before the meal and at 30, 60, 120, 240, and 360 min postprandial.There were no statistically significant differences involving patients' metabolic control, C-peptide, glucagon secretion, or duration of diabetes between Group A and B. In Group A the significant glucose increment occurred at 120-360 min, with its maximum at 240 min: 60.2 versus -3.0 mg/dL (P=0.04), respectively. There were no significant differences in glucagon and C-peptide concentrations postprandial.A mixed meal effectively elevates postprandial glycemia after 4-6 h. Dual-wave insulin bolus, in which insulin is calculated for both the carbohydrates and fat proteins, is effective in controlling postprandial glycemia.

INTRODUCTION Although numerous studies showed an improvement in glycemic control in type 1 diabetic patients treated with long-acting insulin analogue detemir compared with Neutral Protamine Hagedorn (NPH) insulin, the beneficial effects of insulin detemir has not been confirmed by all investigators. OBJECTIVES The aim of the study was to compare the effect of treatment with detemir insulin vs. NPH insulin on metabolic control, hypoglycemic episodes, and body weight gain in patients with type 1 diabetes by means of a systematic review and a meta-analysis. METHODS The following electronic databases were searched up to November 2010: MEDLINE, EMBASE, and the Cochrane Library. Additional references were obtained from the reviewed articles. Only randomized controlled trials of at least 12-week duration with basal-bolus regimen therapies using detemir insulin vs. NPH insulin were included. RESULTS The analysis included 10 studies involving 3825 patients with type 1 diabetes. Combined data from all trials showed a statistically significant reduction in hemoglobin A1c (HbA1c) (weighted mean difference: [WMD] -0.073, 95% CI -0.135 to -0.011, P = 0.021) in the detemir group compared with the NPH group. There was also a significant reduction of fasting plasma glucose (FPG) (WMD - 0.977 mmol/l, 95% CI -1.395 to -0.558, P

Patients with type 1 diabetes mellitus have an increase the risk of developing other autoimmune diseases, among them, autoimmune thyroid disease, mainly Hashimoto are more frequently observed. The aim of the study was to assess the prevalence of celiac disease and autoimmune thyroiditis in children and adolescents with type 1 diabetes mellitus.The study included 260 children (124 girls, 136 boys) aged 1.3-18 years (mean 11+/-4.01), the diabetes duration 3.99+/-3.7 years. Endomysial antibody (EMA) was measured and all patients with positive EMA had small-bowel biopsy. Antibodies against thyroperoxidase (a-TPO), thyroglobulin (a-Tg), TSH, fT4, HbA1c and ultrasound examination of thyroid glands were assessed.The prevalence of EMA was 10% (27/260) and 9% (25/260) had biopsy-proven celiac disease. The median age of T1DM at onset was significantly lower in patients with EMA than those without EMA 6.2+/-5.6 vs. 7.7+/-4.2 p=0.04. 20% of children diagnosed with type 1 diabetes at age4 years had celiac disease p=0.001. The prevalence of thyroid antibodies was 29% (75/260). In the group with positive thyroid antibodies, in 28% (21/75) thyroid ultrasonography showed scattered hypoechogenicity and 23% (17/75) required treatment with thyroxine. Children with positive a-TPO had higher TSH level (2.87+/-2.1 vs. 1.95+/-0.9) p0.01 and HbA1c level (8.32+/-1.64 vs. 7.59+/-1.67) p=0.03 than children without thyroid antibodies. More frequently thyroid antibodies were positive in girls than in boys.Out of five patients with T1DM, one is diagnosed with Hashimoto or celiac disease. Both diseases occurred independently. Autoimmune thyroid disease and celiac disease occur more frequently in children with T1DM, therefore screening at an onset and repeated measurements are recommended.

Background: An insulin pump is an advanced technology offering new options of bolus – normal (N), dual wave (D-W) or square wave (S-W) bolus to deliver mealtime insulin. Objectives: To assess the impact of D-W/S-W boluses on metabolic control (glycated haemoglobin A1c, HbA1c) and to estimate the paediatric patients compliance with implementation of this system in daily practice. Methods: The cross-sectional study included 499 records of patients aged 0–18 yr. Data from the insulin pump memory provided information on the number of D-W/S-W boluses during a 2-wk period, the insulin requirement (U/kg/d) and the percentage of basal insulin. The HbA1c value (%) and the patient’s weight were determined during medical examinations. Mealtime dose of insulin in D-W/S-W bolus was calculated based on the amount of carbohydrate and fat/protein products. Results: The number of applied D-W/S-W boluses was 16.6 ± 0.77/14 d (ranged 0–95), while 18.8% of patients did not program D-W/S-W boluses. The lowest HbA1c value was found in the group using two and/or more D-W/S-W boluses per day (p = 0.001) compared with the group administrating less than one D-W/S-W bolus/d. Patients with HbA1c level