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

Pituitary Adenomas in Multiple Endocrine Neoplasias Type1 and Other Endocrine Neoplasias Syndromes

Multiple Endocrine Neoplasias (MEN) are very rare genetic syndromes. Pituitary adenomas (PA) are usually sporadic, but can be observed in MEN type 1 and in other genetic syndromes such as Carney’s complex syndrome, MEN type 4 (MEN4), and some hereditary pheochromocytomas/paragangliomas syndromes (HPPS).Our aim was to analyze PA’s frequency and characteristics in aforementioned syndromes observed in our department.Material and Methods: The retrospective study analyzed frequency and characteristics of PA associated to typical and atypical MENs. We excluded incomplete files and MEN2, as research for PA was not systematic, and we looked for MEN2 in PA too. The patients did not undergo genetic testing.Results: Among ten hereditary syndromes (six MEN1 and four atypical MENs: either NEM4 or HPPS), we observed eight PA =80%. Four PA were associated with MEN1 and four with non-classical MENs. PA revealed MENs in four cases. PA median height was 19.88mm (7-50). Six/eight were macro tumors (≥1cm in height), with cavernous sinus invasion in two. PA types were prolactinomas (two), somatotroph adenomas (two), gonadotroph adenoma (one) and non-secreting tumors (three). For the follow up, only two out of six treated patients achieved remission.Conclusion: In this series, PA were frequent (80%) in MEN1 and non-classical MENs. Macro adenomas and secreting tumors were prevailing with a variable aggressiveness. These syndromes genetically determined should have systematic genetic screening to specify MENs types and for rapid diagnosis and early management of affected patients and their families

Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study

International audienceAbstract Background Exocrine pancreatic insufficiency (EPI) can be associated with all types of diabetes. Pancreatic enzyme replacement therapy (PERT) has short and long-term benefits in subjects with EPI, but its effects on diabetes control are uncertain. We aimed to study the effects of PERT initiation on glycemic control in subjects with diabetes and EPI from any cause. Methods In this retrospective study, we compared subjects with EPI and diabetes who were prescribed PERT with subjects with diabetes who had a fecal elastase-1 concentration dosage, but did not receive PERT. The primary outcome was the effect of PERT on hypoglycemia frequency and severity. The secondary outcomes were the effects of PERT on gastro-intestinal disorders, HbA 1c and body mass index (BMI). Results 48 subjects were included in each group. Overall, PERT did not have any significant effect on hypoglycemia frequency or severity, but hypoglycemia frequency tended to decrease in subjects with chronic pancreatitis. While 19% of subjects experienced mild hyperglycemia after PERT initiation, we did not report any keto-acidosis or any other severe adverse event. Gastro-intestinal disorders improved in 80% of subjects treated with PERT, versus in 20% of control subjects ( p = 0.02). Gastro-intestinal disorders improved in 87% of subjects with recommended dosage of PERT, versus in 50% of subjects with underdosage (NS). HbA 1c and BMI evolution did not differ between the groups. Conclusions PERT initiation is safe in subjects with diabetes and EPI. It does not globally decrease hypoglycemia severity of frequency, but is associated with a decrease in gastro-intestinal disorders. Trial registration Retrospectively registered. The database was registered with the Commission Nationale Informatique et Libertés (CNIL), registration number: 2203351v0. The study was approved by the local ethics committee CLEP, registration number: AAA-2023-0904

Gonadal Function in Men with Cushing Syndrome

Cushing syndrome (CS) is scarcely observed in males. Because of this rarity, the real prevalence of gonadal dysfunction in men with hypercortisolism is unknown. Our aim was to analyze gonadal abnormalities in 37 males with CS (median age=28.9±11years) comparatively to age matched healthy men (n=10). For the homogeneity of the study men over 50, children, patients taking medications and those with pituitary deficits were systematically excluded. For the remaining group, we took into account medical history, clinical examination, and hormonal assessment, by radio immunoassay, for testosterone (T), prolactin (PRL), follicle stimulating hormone (FSH), and luteinizing stimulating hormone (LH).Results: 21% consulted for impotency and/or gynecomastia. When questioned, 65.7% complained about decreased libido and erectile dysfunction. Except for 3, body hair growth and repartition, and testicular volume were normal. Gynecomastia was observed in 18.9%.Testosterone was equal to 2.79±1.62ng/ml vs 6.69±3.87ng/ml (p<0.0005). Low testosterone (<3ng/ml) was observed in 67.5%. PRL =9.8 ± 4.2ng/ml vs 4.9 ± 2.6ng/ml (p<0.01). FSH = 3.87 ± 1.9mu/ml vs 3.75 ± 2.25mU/ml (p<0.30). LH = 2.7 ± 2.2mU/ml vs 3.66 ± 0.86 (p<0.30). We have not found any correlation between cortisol and T, PRL or LH, but there was a positive and significant one with FSH (r=0.57, p<0.005).Conclusion: CS causes a franc hypogonadism in 65%. According to FSH and LH results glucocorticoids excess acts probably at hypothalamic pituitary level, but an increase in testosterone degradation and/or inhibition of testis receptors cannot be ruled out. So men with hypogonadism and/or gynecomastia should be systematically checked for CS

Type 1 Diabetes in People Hospitalized for COVID-19: New Insights From the CORONADO Study

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The association between macrovascular complications and intensive care admission, invasive mechanical ventilation, and mortality in people with diabetes hospitalized for coronavirus disease-2019 (COVID-19)

International audienceAbstract Background It is not clear whether pre-existing macrovascular complications (ischemic heart disease, stroke or peripheral artery disease) are associated with health outcomes in people with diabetes mellitus hospitalized for COVID-19. Methods We conducted cohort studies of adults with pre-existing diabetes hospitalized for COVID-19 infection in the UK, France, and Spain during the early phase of the pandemic (between March 2020—October 2020). Logistic regression models adjusted for demographic factors and other comorbidities were used to determine associations between previous macrovascular disease and relevant clinical outcomes: mortality, intensive care unit (ICU) admission and use of invasive mechanical ventilation (IMV) during the hospitalization. Output from individual logistic regression models for each cohort was combined in a meta-analysis. Results Complete data were available for 4,106 (60.4%) individuals. Of these, 1,652 (40.2%) had any prior macrovascular disease of whom 28.5% of patients died. Mortality was higher for people with compared to those without previous macrovascular disease (37.7% vs 22.4%). The combined crude odds ratio (OR) for previous macrovascular disease and mortality for all four cohorts was 2.12 (95% CI 1.83–2.45 with an I 2 of 60%, reduced after adjustments for age, sex, type of diabetes, hypertension, microvascular disease, ethnicity, and BMI to adjusted OR 1.53 [95% CI 1.29–1.81]) for the three cohorts. Further analysis revealed that ischemic heart disease and cerebrovascular disease were the main contributors of adverse outcomes. However, proportions of people admitted to ICU (adjOR 0.48 [95% CI 0.31–0.75], I 2 60%) and the use of IMV during hospitalization (adjOR 0.52 [95% CI 0.40–0.68], I 2 37%) were significantly lower for people with previous macrovascular disease. Conclusions This large multinational study of people with diabetes mellitus hospitalized for COVID-19 demonstrates that previous macrovascular disease is associated with higher mortality and lower proportions admitted to ICU and treated with IMV during hospitalization suggesting selective admission criteria. Our findings highlight the importance correctly assess the prognosis and intensive monitoring in this high-risk group of patients and emphasize the need to design specific public health programs aimed to prevent SARS-CoV-2 infection in this subgroup