Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!)

AIM: To compare the efficacy of three strategies for real-time continuous glucose monitoring (RT-CGM) over 12 months in children and adolescents with type 1 diabetes. METHODS: A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel-group design was conducted. After 3 months of RT-CGM, patients were allocated to one of three groups: return to self-monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost. RESULTS: We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full-time RT-CGM for 3 months costs the national medical insurance system €2629 per patient. CONCLUSION: None of the three long-term RT-CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM-use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long-term RT-CGM-use and the need to improve educational support for patients and caregivers

Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries

AIMS/HYPOTHESIS: 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. METHODS: 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. RESULTS: 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 7.5%. The incidence of severe hypoglycaemia and ketoacidosis was 6.63 and 6.26 events per 100 patient-years, respectively. CONCLUSIONS/INTERPRETATION: 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)

[French version and validation of a scale evaluating compliance in diabetic children].

International audienceIn order to evaluate the educational needs of diabetic children, a study was performed to validate a scale for adherence to treatment (compliance) by diabetic children. The lack of such scales in France, led us to validate an existing American scale. After a classic linguistic translation, back-translation, and a pilot study, 165 diabetic children aged 7 to 13 years filled out a 25 item questionnaire that assessed four areas: glucose testing, diet, hypoglycemia, insulin adjustment. Face validity as measured by response rates was excellent and the reliability as measured by Cronbach's alpha was good (alpha = 0.65) as in the American scale. Concordant validity was studied: the insulin adjustment score was inversely correlated with hypoglycemia (r = -0.23, p < 0.01); age (r = 0.28, p < 0.001), age at diagnosis (r = 0.18, p < 0.05), and diabete knowledge (r = 0.47, p < 0.001) were all correlated with adherence. The French version of the adherence to treatment scale is valid and reliable for the study of adherence to treatment in diabetic children. This scale provides an evaluative tool that will facilitate the performance of an educational diagnosis

The association of poor adherence and acute metabolic disorders with low levels of cohesion and adaptability in families with diabetic children

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Psychological adjustment in a french cohort of type 1 diabetic children. PEDIAB Collaborative Group.

International audienceThe aim of the study was to determine whether IDDM affects the course of psychological adjustment in youths. The study sample included 164 children with IDDM (mean age=10.2) and their parents compared to 164 healthy controls matched for age, sex and socioeconomic status. Adjustment was measured with the Child Behavior Checklist, a parental rating scale, validated and adapted for the French population. Two-way ANOVAs on CBCL scale scores showed that scores for both internalizing and externalizing problem behaviors and the total CBCL score were significantly raised in diabetic children (p<0.001). Further comparisons on the 8 narrow-band scale scores of the CBCL indicated increased scores for diabetic children on 6 dimensions. A significant Gender x Status (IDDM versus Controls) interaction was found, supportive of higher rates of aggressive behaviors amongst male diabetic children (p<0.01). Controlling for age, no correlation was found between CBCL total, internalizing and externalizing scores and duration of IDDM or HbA1c levels within the diabetic group. Psychological adjustment to chronic illness needs to be considered with respect to both normal developmental demands as well as in the context of the specific challenges posed by the disease

Risk Factors for Poor Glycemic Control in Diabetic Children in France

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[Health and factors associated with glycemic control in 165 children with insulin-dependent diabetes, aged 7-23 year].

International audienceA multicenter cross-sectional study was the first step of a project aimed at performing an educational diagnosis for IDDM children in France

[French-language adaptation of an evaluation test of knowledge meant for insulin-dependent children: methodology and value for research in clinical practice].

International audienceA measure of knowledge level of diabetic patients is useful in evaluating their educational needs as well as the impact of the educational programs specifically designed for them. The lack of such scales in French, led us to translate and validate an existing knowledge scale for diabetic children, the Test of Diabetes Knowledge (TDK) (Johnson et al.). After several translations and back translations, the 33 item scale was submitted to the staff members of a pediatric diabetology unit, to establish its content validity. An assessment the questionnaire was performed in a group of 49 children, aged 7.9 to 12.8 years. The mean duration of diabetes was 4.6 +/- 2.9 years and their scholastic level varied from 1st to 6th grades. Time spent in filling out the questionnaires was 12 to 25 minutes. Few missing values were noted. The reliability of the scale was excellent as shown by Cronbach's alpha coefficient: 0.83 for the overall scale, 0.72 for the general knowledge subscale (20 items) and 0.70 for the problem solving subscale (13 items). The level of correct responses was correlated with age and scholastic level (p < 0.0001), but not with sex, duration of diabetes, or HbA1c levels. This study shows that the French version of the TDK is a valid and reliable tool for measuring the level of knowledge in children and adolescents with diabetes. This scale provides the researcher and clinician with a tool that facilitates the performance of an educational diagnosis and the evaluation of educational programs based on the transmission knowledge