The effect of bolus and food calculator Diabetics on glucose variability in children with type 1 diabetes treated with insulin pump: the results of RCT.

BACKGROUND: The calculation of prandial insulin dose is a complex process in which many factors should be considered. High glucose variability during the day, arising from difficulties which include errors made in food counting and inappropriate insulin adjustments, influence hemoglobin A1c levels. During this study, in children using insulin pumps to manage type 1 diabetes, we compared 2-h postprandial blood glucose levels (BGL) and glucose variability when calorie tables and mental calculation were used, to when Diabetics software was used. METHODS: This 3-month, randomized, open-label study involved 48 children aged 1-18 yr. Patients were educated in food counting system used in the Warsaw Pump Therapy School (WPTS) where the carbohydrate unit (CU) and the fat-protein unit (FPU) are taken into account. The children were randomly allocated to an experimental group (A) who used diabetics software and a control group (B) who used caloric tables and mental calculations. RESULTS: We observed significant differences (p < 0.05) between the groups in 2-h postprandial BGL's and the glucose variability parameters mean(T), SD(T), % BGL in the target range 70-180 mg/dL, and high blood glucose index HBGI. We did not observe statistically significant differences in hypoglycemic events or low blood glucose index (LBGI) nor in HbA1c or insulin requirements. CONCLUSIONS: The use of the Diabetics software by patients educated at the WPTS is safe and reduces 2-h postprandial BGL's and glucose variability.

[Quality of treatment in children with type 1 diabetes based on the Polish Prospective Pump Programme]. / Jakosc leczenia dzieci z cukrzyca typu 1 w oparciu o ogolnopolski prospektywny program leczenia przy uzyciu pomp insulinowych.

BACKGROUND: In pediatric patients with type 1 diabetes mellitus, the value of HbA1c is a predictor of the risk of late systemic complications in adulthood. In the last years significant changes in the method of treatment in pre-pubertal children with T1DM have taken place. However, there is lack of precise data concerning the results of metabolic control of this group of patients. THE AIM: was to assess the impact of the Polish Prospective Insulin Pump Programme (OPPLP) on the quality of metabolic control in prepubertal children with T1DM. The OPPLP included also education for diabetological staff (HPC) from the Polish Diabetic Centres as well as standardization of continuous subcutaneous insulin infusion (CSII) implementation procedures. MATERIAL AND METHODS: Population studies were conducted in the years: 2005-2008. 920 patients were enrolled at age from 1.2 to 14.6 years (median 8.5 years). 71.75 % of patients were in pre-pubertal age. 734 patients received CSII therapy. The cross sectional, prospective study, conducted according to the protocol of the OPPLP with clinical data collection from 2005 to 2008. We analyzed the data obtained during 1657 visits and assessed 1657 blood samples for HbA1c value in the Central Laboratory. The clinical data were recorded in the electronic net-database. RESULTS: In whole group the median of HbA1c was 7.46 % (min. 5% - max. 12.1%); 60.1% patients has HbA1c below 7.5%. The quality of treatment was comparable among the centres: med. HbA1c ranged from min. 6.5% to max. 8.0%. During the period from 2005 to 2008 effective results were obtained in glycemic control: med. HbA1c: 2005 - 7.6%, 2006 - 7.2%, 2007 - 7.0% and 2008 - 7.5%. Slightly higher HbA1c was observed in children with longer duration of diabetes (r=0.17, p<0.005). CONCLUSIONS: The OPPLP, including HCP education, enabled optimalization of metabolic control in the prepubertal children switched pump therapy. Moreover, the programme brought about an even level of treatment between the Polish Diabetic Centres irrespective of their size. It is important to continue the programme and to develop a country level register of children with T1DM.

Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study.

BACKGROUND: 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. SUBJECTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users.

Bolus calculators are effective tools in controlling blood glucose levels in patients treated with insulin. Diabetics is a new software devised for patients to facilitate and improve self-managing for prandial insulin dosing and for better controlling food intake. This device contains two integral parts: a nutrition database and a bolus calculator. The algorithm is based on a formula in which carbohydrate (CHO) and either fat and/or protein (FP) products are engulfed in insulin. The insulin dose setting is programmed individually for CHO in a normal bolus (N-W) and for FP in a square-wave bolus (S-W). The device calculates the dose of insulin for N-W or S-W, suggests the optimal kind of bolus, and indicates the timing in hours for an S-W bolus. In addition, this calculator, which contains a nutrition database and insulin dosing software, helps determine the correct type of necessary boluses for selected foods.

The education of patients in prandial insulin dosing related to the structure of bolus calculators.

The metabolic effect of insulin pump therapy depends on precise adjustments of insulin to food intake ratio. Calculation of prandial insulin dose is a complex process employing many variant factors such as pre-prandial glucose and carbohydrate (CHO) levels, glucose index, insulin to CHO ratio (ICR) and active insulin. Bolus calculators are very effective in controlling blood glucose level in patients treated with continuous subcutaneous insulin infusion (CSII). Most of modern bolus calculators are built into the insulin pump unit and are only accessible to pump users. In addition, some models offer nutrition database. Patients' education is an essential step in proper interpretation and application of bolus calculators' various algorithms.

Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes.

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 <7.5% had a statistically higher relevant number of D-W/S-W boluses, 19.55 (95% CI: 17.44-21.65) vs. 12.42 (95% CI: 10.22-14.61) (p < 0.001), while there was no correlation between the number of boluses and HbA1c in patients in the remission phase (<0.5 IU/kg/d) (r = 0.012, p = 0.930). CONCLUSIONS: Patients using at least one D-W/S-W bolus per day achieved a recommended level of HbA1c. Paediatric patients with type 1 diabetes mellitus were found to be able to apply D-W/S-W boluses in daily self-treatment process based on food counting.

Insulin requirement in preschoolers treated with insulin pumps at the onset of type 1 diabetes mellitus.

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<0.0001). In the third month, 46% of children were without basal insulin; this group included significantly older children (3.7 +/- 1.4 vs. 2.8 +/- 1.4 years; p = 0.01), which had lower TDD (0.33 +/- 0.18 vs. 0.54 +/- 0.23 u/kg/d; p = 0.0007) than children with basal insulin. HbA1c persisted < or =7.3%. CONCLUSION: In preschool children initiated on CSII therapy at the time of T1DM diagnosis the first year of treatment is critical for altering the basal insulin dose. Preschoolers with TDD lower than 0.5 U/kg/d may not require basal insulin. Moreover, basal insulin did not exceed 30% of TDD in the first years after T1DM onset.

Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials.

OBJECTIVE: To investigate potential effects of continuous subcutaneous insulin infusion (CSII) compared with multiple daily injections (MDI) on glycemic control in children with type 1 diabetes mellitus (T1DM). STUDY DESIGN: Meta-analysis and systematic review of randomized control studies (RCTs). The electronic databases MEDLINE, Cochrane Library, and EMBASE were searched through October 2007. RESULTS: Six RCTs involving 165 participants with T1DM met our predefined inclusion criteria. Combined data from all trials showed that the CSII group compared with the MDI group experienced a significant reduction in the level of glycosylated hemoglobin. The pooled weighted mean difference (WMD) was -0.24% [95% confidence interval (95% CI) -0.41 to -0.07, p < 0.001] with a fixed model and remained significant in the random effect model. This effect was reached by slightly decreasing insulin requirement [three RCTs, n = 74, WMD -0.22 IU/kg/d (95% CI -0.31 to -0.14, p < 0.001)]. No differences in the incidences of ketoacidosis and severe hypoglycemic events were found. CONCLUSIONS: In short-term insulin therapy, CSII compared with MDI is a more effective form of metabolic control and allows reducing the daily insulin requirement. Yet, no conclusions have been made so far whether this effect holds in later years. These results should be approached with caution because of the methodological limitations of the analyzed studies.

Age-dependent basal insulin patterns in children with type 1 diabetes treated with continuous subcutaneous insulin infusion.

AIMS: Identifying age-dependent basal rates in type 1 diabetic children treated with continuous subcutaneous insulin infusion (CSII). METHODS: CSII-treated children with type 1 diabetes exhibiting insulin requirement > 0.5 U/kg and glycated haemoglobin (HbA1c) < 8%. The study population was composed of 198 Caucasian children (111 girls) with mean age of 9.8 +/- 3.8 years, mean duration of diabetes of 4.3 +/- 3.1 years and mean HbA1c value of 6.7 +/- 0.7%. Data were evaluated for four age groups (0-6; 6-9; 9-12, 12-18 years). Basal rates records were downloaded from pump memory. HbA1c, weight, height were measured at scheduled visits. RESULTS: Significant differences in the average hourly basal rate between groups were observed: I gr. 0.14 versus II gr. 0.24 versus III gr. 0.39 versus IV gr. 0.72 units/h; p < 0.0001. The average hourly basal rate correlated with age, body weight, BMI, diabetes duration and total insulin daily dose. Insulin peaks were observed for: I gr. - before midnight, II gr. - before midnight and in the early morning, gr. III and IV - in the early morning. CONCLUSION: Basal insulin infusion rate profiles in well-controlled paediatric patients on CSII reflect the age-dependent amount of basal insulin (20-40%) and affect circadian distribution of insulin needs.

[The prevalence of autoimmune thyroid disease and celiac disease in children and adolescents with type 1 diabetes mellitus]. / Czestosc wystepowania autoimmunologicznego zapalenia tarczycy i celiakii u dzieci i mlodziezy z cukrzyca typu 1.

INTRODUCTION: 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. MATERIAL AND METHODS: 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. RESULTS: 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 age <4 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) p<0.01 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. CONCLUSIONS: 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.