Three-year comparison of subcutaneous insulin pump treatment with multi-daily injections on HbA1c, its variability and hospital burden of children with type 1 diabetes.
ABSTRACT Treatment with continuous subcutaneous insulin infusion (CSII) allows a large degree of treatment individualization and intensification in children with diabetes. The study's aim was to evaluate the impact of treatment with CSII on glycated haemoglobin level (HbA1c) in children with diabetes and investigate whether introduction of CSII is associated with an increased risk of acute complications of diabetes. Patients treated throughout the recruitment period exclusively with multiple daily injections (MDI) were matched for duration of diabetes and HbA1c level at baseline with patients treated exclusively with CSII in a 1:1 group ratio (n = 223 and 231 for MDI and CSII, respectively). The CSII group showed lower HbA1c after the observation period (7.98 ± 1.38 vs. 7.56 ± 0.97; P = 0.002). HbA1c variability measured as standard deviations of average values was also lower in the CSII group (0.73 ± 0.45 vs. 0.84 ± 0.54; P = 0.049). The rate of hospitalization due to acute events was similar in both groups (14.7/100 vs. 14.0/100 person/years in the MDI and CSII group, P = 0.72). Duration of hospital stay per year was on average 1.25 days shorter in the CSII group (P = 0.0004), but the risk of acute complications resulting in hospitalization did not differ between the groups (hazard ratio (HR) 1.16; 95% confidence interval (95% CI) 0.68-1.63). The most significant risk factor for hospitalization due to acute complications was baseline HbA1c concentration (HR 1.25; 95% CI 1.14-1.37). In conclusion, CSII treatment may improve glycemic control and reduce its variability. Change of MDI to CSII does not alter the risk of hospitalization and may reduce the annual duration of hospitalization in children with diabetes.
Article: Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries.[show abstract] [hide abstract]
ABSTRACT: To assess the use of paediatric continuous subcutaneous infusion (CSII) under real-life conditions by analysing data recorded for up to 90 days and relating them to outcome. Pump programming data from patients aged 0-18 years treated with CSII in 30 centres from 16 European countries and Israel were recorded during routine clinical visits. HbA(1c) was measured centrally. A total of 1,041 patients (age: 11.8 +/- 4.2 years; diabetes duration: 6.0 +/- 3.6 years; average CSII duration: 2.0 +/- 1.3 years; HbA(1c): 8.0 +/- 1.3% [means +/- SD]) participated. Glycaemic control was better in preschool (n = 142; 7.5 +/- 0.9%) and pre-adolescent (6-11 years, n = 321; 7.7 +/- 1.0%) children than in adolescent patients (12-18 years, n = 578; 8.3 +/- 1.4%). There was a significant negative correlation between HbA(1c) and daily bolus number, but not between HbA(1c) and total daily insulin dose. The use of <6.7 daily boluses was a significant predictor of an HbA(1c) level >7.5%. The incidence of severe hypoglycaemia and ketoacidosis was 6.63 and 6.26 events per 100 patient-years, respectively. This large paediatric survey of CSII shows that glycaemic targets can be frequently achieved, particularly in young children, and the incidence of acute complications is low. Adequate substitution of basal and prandial insulin is associated with a better HbA(1c).Diabetologia 08/2008; 51(9):1594-601. · 6.81 Impact Factor
Article: Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial.[show abstract] [hide abstract]
ABSTRACT: The goal of the study was to determine whether continuous subcutaneous insulin infusion (CSII) differs from a multiple daily injection (MDI) regimen based on neutral protamine hagedorn (NPH) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes. The 5-Nations trial was a randomized, controlled, crossover trial conducted in 11 European centres. Two hundred and seventy-two patients were treated with CSII or MDI during a 2-month run-in period followed by a 6-month treatment period, respectively. The quality of glycaemic control was assessed by HbA(1c), blood glucose values, and the frequency of hypoglycaemic events. For the evaluation of the quality of life, three different self-report questionnaires have been assessed. CSII treatment resulted in lower HbA(1c) (7.45 vs. 7.67%, P < 0.001), mean blood glucose level (8.6 vs. 9.4 mmol/l, P < 0.001) and less fluctuation in blood glucose levels than MDI (+/- 3.9 vs. +/- 4.3 mmol/l, P < 0.001). There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI, with an incidence ratio of 1.12 [95% confidence interval (CI): 1.08-1.17] and 2.61 (95% CI: 1.59-4.29) for mild and severe hypoglycaemia, respectively. The overall score of the diabetes quality of life questionnaire was higher for CSII (P < 0.001), and an improvement in pump users' perception of mental health was detected when using the SF-12 questionnaire (P < 0.05). CSII usage offers significant benefits over NPH-based MDI for individuals with Type 1 diabetes, with improvement in all significant metabolic parameters as well as in patients' quality of life. Additional studies are needed to compare CSII with glargine- and detemir-based MDI.Diabetic Medicine 02/2006; 23(2):141-7. · 2.90 Impact Factor
Article: Investigation of quality of life and family burden issues during insulin pump therapy in children with Type 1 diabetes mellitus--a large-scale multicentre pilot study.[show abstract] [hide abstract]
ABSTRACT: To investigate psychosocial aspects of continuous subcutaneous insulin infusion (CSII) therapy in children with Type 1 diabetes and to identify relevant and sensitive measures. We performed a multi-centre prospective pre-/post-study with children (53 girls, 64 boys, age 10.5 +/- 3.7 years, mean +/- sd) with Type 1 diabetes and their main carer from 18 German diabetic centres. Twenty-five children aged 8-11 years and 63 adolescents aged 12-16 years and their parents, plus 29 parents of children aged 4-7 years completed standardized questionnaires on generic and diabetes-specific quality of life (QOL), generic parenting stress, mealtime behaviour, fear of hypoglycaemia and family conflict immediately before and 6 months after transition to CSII. After transition to CSII, diabetes-specific QOL of children increased significantly (P < 0.001) in all age groups, with moderate to large effect sizes (children aged 4-7 years: Cohen's effect sized = 1.3; 8-11 years: d = 0.9, adolescents 12-16 years: d = 0.6). Parents reported reduced frequency (P < 0.01, d = 0.4-0.7) and difficulty (P < 0.01, d = 0.3-0.6) of overall parenting stress and decreased worries about hypoglycaemia (P < 0.01, d = 0.4-0.6). Parents of younger children (4-7 years) reported reduced problems with nutrition management (frequency: P < 0.001, d = 1.1; difficulty: P < 0.05, d = 0.7). CSII may have substantial psychosocial benefits. Controlled studies are needed.Diabetic Medicine 05/2009; 26(5):493-501. · 2.90 Impact Factor