Enfants diabétiques de parents migrants (peut-on intégrer leur différence culturelle dans la prise en charge médicale ?)

PARIS5-BU Méd.Cochin (751142101) / SudocPARIS-BIUM (751062103) / SudocCentre Technique Livre Ens. Sup. (774682301) / SudocSudocFranceF

How to collect non-medical data in a pediatric trial: diaries or interviews

International audienceBACKGROUND:Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that patients and caregivers spend in seeking and providing care (which are the indirect costs in an economic evaluation) can be significantly different depending on the treatment arm. To explore methods for collecting information on the care burden for caregivers and patients, we investigated whether a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary that was completed intermittently produced more or less information than a diary completed continually. The main objective of this study was to identify which type of data collection was most effective for measuring the time spent by caregivers and for estimating indirect treatment costs over 9 months.METHODS:Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to assess methods of collecting information on the time spent by patients and caregivers in managing their condition (indirect costs). Data were entered retrospectively in case report forms (CRFs) by investigators during quarterly follow-up visits, which were supplemented with diaries completed prospectively by children or caregivers either continuously or intermittently. Data about absences from school and work as well as the time that caregivers spent on diabetes care were collected and the three collection methods were compared.RESULTS:At the end of the 9-month study, 42% of the study participants failed to return their diary. For the diaries that were received, less than 10% of expected data were collected versus 82% during investigators'interviews. Based on all the information collected, we calculated that over 9 months, caregivers lost on average 3.9 days of working time (€786) and 4 days of personal time, i.e. the equivalent of €526, and spent around 15 min of time on care per day, i.e. the equivalent of €1700.CONCLUSIONS:The CRFs completed by investigators during quarterly visits cannot be replaced by a diary. Completing the diaries appeared to represent an important additional burden to children and their caregivers, and the diaries provided little additional information compared to investigators' entries in the CRF.TRIAL REGISTRATION:ClinicalTrials.gov, NCT00949221. Registered on 30 July 2009. Registry name: Study of Insulin Therapy Augmented by Real Time Sensor in Type 1 Children and Adolescents (START-IN!)

A Simple and Fast Non-Radioactive Bridging Immunoassay for Insulin Autoantibodies

Type 1 diabetes (T1D) is an autoimmune disease which results from the destruction of pancreatic beta cells. Autoantibodies directed against islet antigens are valuable diagnostic tools. Insulin autoantibodies (IAAs) are usually the first to appear and also the most difficult to detect amongst the four major islet autoantibodies. A non-radioactive IAA bridging ELISA was developed to this end. In this assay, one site of the IAAs from serum samples is bound to a hapten-labeled insulin (GC300-insulin), which is subsequently captured on anti-GC300 antibody-coated 96-well plates. The other site of the IAAs is bound to biotinylated insulin, allowing the complex to be detected by an enzyme-streptavidin conjugate. In the present study, 50 serum samples from patients with newly diagnosed T1D and 100 control sera from non-diabetic individuals were analyzed with our new assay and the results were correlated with an IAA radioimmunoassay (RIA). Using IAA bridging ELISA, IAAs were detected in 32 out of 50 T1D children, whereas with IAA RIA, 41 out of 50 children with newly diagnosed T1D were scored as positive. In conclusion, the IAA bridging ELISA could serve as an attractive approach for rapid and automate

Comparison of IAA levels obtained by IAA bridging ELISA and RIA.

<p>Serum samples from 50 newly diagnosed T1D children and 100 control subjects were analyzed with both methods and the two assays were correlated. The dotted lines indicate the cut-off values. mAU, milli-absorbance unit.</p

Principle of the IAA bridging ELISA.

<p>Serum sample or calibrator is incubated with GC300- and biotin-labeled insulin prior to transfer into anti-GC300 (MC159) mAb-coated wells. Serum IAAs form a bridge between GC300- and biotin-labeled insulin and this complex is captured on the solid phase of the MC159-coated plate. Biotin-labeled insulin bound to IAAs is detected using AChE-labeled streptavidin and the enzymatic activity is measured at 414 nm.</p

Competitive inhibition of IAA binding with unlabeled insulin.

<p>One IAA-positive and one IAA-negative serum sample (A) and eight IAA-positive serum samples (B) were incubated with 0, 5, 50, 500 and 5,000 ng/mL (A) or with 5,000 ng/mL (B) of unlabeled insulin together with biotinylated and GC300-labeled insulin in the first incubation step of the IAA bridging ELISA. White bars represent signals without addition of unlabeled insulin and black bars represent signals with addition of unlabeled insulin. mAU, milli-absorbance unit.</p

Comparison of the bridging ELISA and the ECL assay for the detection of anti-insulin mAb-spiked sera.

<p>An IAA-negative serum was spiked with serial dilutions of an anti-insulin mAb (0–50 ng/mL) and assayed in parallel with the two techniques with a 3-h incubation time. The five-parameter logistic fit was used to model the characteristic curve for both IAA bridging ELISA and ECL assay. The inset shows the low-concentration part of the curve and dotted lines indicate the positive cut-off values of the assays. Signal units: milli-absorbance units (mAU) for ELISA and ECL intensity for ECL.</p