Validation of the Body Scan®, a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan®

BackgroundSudomotor dysfunction is one of the earliest manifestations of small fiber neuropathy (SFN), reflecting the alteration of sympathetic C fiber innervation of the sweat glands. Among other techniques, such innervation can be assessed by measuring electrochemical skin conductance (ESC) in microsiemens (μS). In this study, ESC was measured at the feet to detect distal SFN. For this objective, the performance of a new device, the Body Scan® (Withings, France), intended for home use, was compared with that of a reference device, the Sudoscan® (Impeto Medical, France), which requires a hospital setting.MethodsIn patients with diabetes with or without neuropathy or non-diabetic patients with lower-limb neuropathy, the diagnostic performance of the Body Scan® measurement was assessed by calculating its sensitivity (Se) and specificity (Sp) to detect at least moderate SFN (Se70 and Sp70), defined by a value of feet ESC ≤ 70 μS and > 50 μS on the Sudoscan® measure, or severe SFN (Se50 and Sp50), defined by a value of feet ESC ≤ 50 μS on the Sudoscan® measure. The agreement between the two devices was assessed with the analysis of Bland–Altman plots, mean absolute error (MAE), and root mean squared error (RMSE) calculations. The repeatability of the measurements was also compared between the two devices.ResultsA total of 147 patients (52% men, mean age 59 years old, 76% diabetic) were included in the analysis. The sensitivity and specificity to detect at least moderate or severe SFN were: Se70 = 0.91 ([0.83, 0.96]), Sp70 = 0.97 ([0.88, 0.99]), Se50 = 0.91 ([0.80, 0.98]), and Sp50 = 0.99 ([0.94, 1]), respectively. The bias and 95% limits of agreement were 1.5 [−5.4, 8.4]. The MAE was 2.9 and the RMSE 3.8. The intra-sample variability was 2.0 for the Body Scan® and 2.3 for the Sudoscan®.ConclusionThe ESC measurements provided by the Body Scan® were in almost perfect agreement with those provided by the reference device, the Sudoscan®, which validates the accuracy of the Body Scan® for the detection of SFN. By enabling simple, rapid, and autonomous use by the patient at home, this new technique will facilitate screening and monitoring of SFN in daily practice.Clinical trial registrationClinicalTrials.gov, identifier NCT05178459

Contribution de l'hyperglycémie au risque cardiovasculaire des diabétiques de type 2

Il s agit de travaux de Recherche Clinique sur la thématique Une intervention chez des diabétiques de type 2 entraînant le retour à une glycémie normale permet elle le retour à un risque cardiovasculaire proche de celui de la population générale ? . Le travail présenté, réalisé de 2004 à 2007 sous la direction du Pr Marre, en collaboration avec l Université de Sydney contribue à y répondre. L essai ADVANCE auquel j ai participé, portait sur 11000 patients diabétiques de type 2 et comparait l effet d une intensification du traitement hypoglycémiant sur le risque de développer ou d aggraver une complication micro/macrovasculaire du diabète. Cette étude a été menée à son terme, nous avons obtenu des résultats interprétables et les avons publiés dans une revue importante : Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes - N Engl J Med. 2008 Jun 12; 358(24):2560-2572. Le contexte, le protocole, les aspects stratégiques et opérationnels, les résultats, et les discussions qui s y rattachent sont développés dans cette thèse. Un programme d analyses et de protocoles à suivre est également introduit.PARIS-BIUSJ-Thèses (751052125) / SudocPARIS-BIUSJ-Physique recherche (751052113) / SudocSudocFranceF

Epidémiologie du prédiabète chez les sujets en surpoids ou obèses et identification de facteurs de risques

PARIS6-Bibl. St Antoine CHU (751122104) / SudocSudocFranceF

Apport de la spectroscopie infrarouge à transformée de Fourier (IRTF) pour la caractérisation de bactéries

CAEN-BU Sciences et STAPS (141182103) / SudocSudocFranceF

Use of Fibrates Monotherapy in People with Diabetes and High Cardiovascular Risk in Primary Care: A French Nationwide Cohort Study Based on National Administrative Databases

<div><p>Background and Aim</p><p>According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk.</p><p>Design</p><p>Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months.</p><p>Methods</p><p>Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and >50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death.</p><p>Results</p><p>Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR_<540) and after 540 days (HR_>540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR_<540 = 0.95 (95% CI: 0.78–1.16) and HR_>540 = 1.73 (1.28–2.32).</p><p>Conclusion</p><p>Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.</p></div

Final Cox models with a cut-off time at 540 days.

<p>Abbreviations: HR, hazard ratio; CI, confidence interval. P-values were calculated using the Cox-proportional hazard model.</p><p>Final Cox models with a cut-off time at 540 days.</p

Predictors of the combined outcome in age- and gender-adjusted Cox models.

<p>Abbreviations: HR, hazard ratio; CI, confidence interval. P-values were calculated using the Cox-proportional hazard model.</p><p>Predictors of the combined outcome in age- and gender-adjusted Cox models.</p

Survival curves for death and cardiovascular events in patients treated with statin or fibrate monotherapy.

<p>Survival curves for death and cardiovascular events in patients treated with statin or fibrate monotherapy.</p