Variance due to the examination conditions and factors associated with success in objective structured clinical examinations (OSCEs): first experiences at Paris-Saclay medical school.

BACKGROUND: We aimed to measure the variance due to examination conditions during the first sessions of objective structured clinical examinations (OSCEs) performed at a French medical school and identify factors associated with student success. METHODS: We conducted a retrospective, observational study using data from the first three OSCEs sessions performed at Paris-Saclay medical school in 2021 and 2022. For all sessions (each organized in 5 parallel circuits), we tested a circuit effect using a linear mixed-effects model adjusted for sex and the average academic level of students (according to written tests). Then, we studied the factors associated with student success at one station using a multivariate linear mixed-effects model, including the characteristics of students, assessors, and standardized patients. RESULTS: The study included three OSCEs sessions, with 122, 175, and 197 students and a mean (± SD) session score of 13.7(± 1.5)/20, 12.7(± 1.7)/20 and 12.7(± 1.9)/20, respectively. The percentage of variance due to the circuit was 6.5%, 18.2% (statistically significant), and 3.8%, respectively. For all sessions, the student's average level and station scenario were significantly associated with the score obtained in a station. Still, specific characteristics of assessors or standardized patients were only associated with the student's score in April 2021 (first session). CONCLUSION: The percentage of the variance of students' performance due to the examination conditions was significant in one out of three of the first OSCE sessions performed at Paris-Saclay medical school. This result seems more related to individual behaviors rather than specific characteristics of assessors or standardized patients, highlighting the need to continue training teaching teams. NATIONAL CLINICAL TRIAL NUMBER: Not applicable.

Long-term health in individuals born preterm or with low birth weight: A cohort study.

BACKGROUND: To measure the association of prematurity and non-preterm low birth weight (LBW) with several long-term health outcomes. METHODS: We selected adult participants from the Constances cohort. Associations between preterm birth (<37 weeks versus ≥37 weeks) and outcomes were measured using modified Poisson regression with adjustment for participant age and parental history. We used the same modeling methods to measure the association between LBW (i.e.,

Early-Life Factors Associated With Adult-Onset Type 1 Diabetes: A Swedish Nationwide Cohort and Family-Based Study.

OBJECTIVE: Childhood-onset type 1 diabetes (T1D) is associated with perinatal factors, but data related to adult-onset T1D are scarce. This study aimed at investigating the association between early-life factors and adult-onset T1D in a Swedish nationwide cohort and family-based study. RESEARCH DESIGN AND METHODS: We included 1,813,415 individuals aged ≥18 years, born in Sweden 1983 to 2002, followed until 2020. T1D diagnosis (n = 3,283) was identified from the National Diabetes, Patient and Prescribed Drugs Registers, and perinatal exposures were obtained from the Medical Birth Register. We performed Cox proportional hazard (hazard ratio [95% CI]) regression with mutual adjustment for perinatal exposures, sex, birth year, and parental sociodemographic background and history of diabetes. We also compared T1D risks among siblings' groups identified from the Multiple Generation Register. RESULTS: The incidence rate of adult-onset T1D was 18.8 per 100,000 person-years. Year of birth (1.06 [1.01-1.10], per five additional years) and history of maternal (4.10 [3.09-5.43]) and paternal (6.24 [5.10-7.64]) T1D were associated with a higher incidence of adult-onset T1D, whereas female sex (0.69 [0.64-0.74]) and having parents born outside Sweden were associated with a lower incidence. Regarding perinatal exposures, only non-full-term birth (<39 weeks vs. ≥39 weeks) was associated with a higher incidence of adult-onset T1D (1.12 [1.04-1.22]). The sibling cohort results were consistent with the full cohort analysis. CONCLUSIONS: Perinatal factors seem to play a minor role in the development of adult-onset T1D compared with childhood-onset T1D, suggesting that triggers or accelerators of autoimmunity occurring later in life are more significant.

Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes.

Objectives: Background investigated whether Ramadan, a yearly religious fasting lasting for 1 month, could challenge the metabolic control obtained under a hybrid closed-loop (HCL) therapy in patients living with type 1 diabetes (T1D). Material and Method: This real-life prospective study involved 20 patients with T1D and moderate to high-risk score of adverse events at baseline. We compared continuous glucose monitoring (CGM) parameters under HCL therapy 1 month before and during the Ramadan fasting month. The main outcome was the evolution of the percentage of time-in-range (TIR, 70-180 mg/dL) between the two time points, and secondary outcomes were the evolution of other CGM parameters and frequency of acute metabolic events. Results: We observed no statistical difference regarding TIR (mean±SD) (63 ± 11% during fasting vs. 62 ± 12% before) as well as for other parameters including time spent under 70 mg/dL (1.1 ± 1.0% vs. 1.5 ± 1.3%) and percentage of HCL use (93 ± 5% vs. 94 ± 5%). No acute metabolic event was observed during fasting under HCL. Results were homogenous across baseline risk score groups.

Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series.

Pancreatic diabetes is associated with glycemic variability, poor metabolic control, and reduced quality of life. Though hybrid closed-loop (HCL) insulin delivery systems were not originally developed for these types of diabetes, they could address the therapeutic challenge. We aimed to evaluate long-term metabolic control in ten adult patients (mean ± SD age: 59 ± 12) treated with HCL insulin delivery systems for pancreatitis or pancreatectomy-induced diabetes. After a median of 346 days (range 64 - 631) with HCL insulin delivery, continuous glucose monitoring showed 59±19 % time-in-range [70-180 mg/dl] (versus 49±24 % before HCL insulin delivery, P = 0. 049) and 0.8 ± 1.0 % time-below-range [< 70 mg/dl] (versus 2.2 ± 2.6 %, P = 0.142), with the coefficient of glucose variability at 35.4 ± 7.6 (versus 37.8 ± 7.1, P = 0.047). HbA1c decreased from 8.5 ± 1.7 % to 7.7 ± 1.3 % [69±18 to 60±14 mmol/mol] (P = 0.076). No patient experienced an acute adverse metabolic event.

Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe!

To evaluate the percentage of patients with type 1 diabetes (T1D) and very poor metabolic control who would agree to be treated with a hybrid closed-loop (HCL) insulin delivery system, and to assess metabolic improvement and safety. In a single center, we identified all patients aged >18 years with hemoglobin A1c (HbA1c) >11% (97 mmol/mol) before HCL treatment. We collected metabolic control and safety data up to 1 year post-HCL in those who accepted HCL after it was proposed to them. We identified 65 patients eligible for the study, 32 (50%) already used, or accepted to start using HCL. Patients were aged 18-49 years; mean(±standard deviation) baseline HbA1c was 12.5(±1.8)% (113 ± 20 mmol/mol). After 1 year, 25 patients (78%) were still using HCL and their mean HbA1c decreased to 9.4(±1.9)% (79 mmol/mol) (P < 0.001). The rate of acute metabolic events was similar during the year of follow-up to the rate in the 3 years before HCL initiation. HCL systems should be considered in patients with T1D and very poor metabolic control. ClinicalTrials registration no. NCT05282264.

Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study.

BACKGROUND: We assessed the performance and patient satisfaction of a new insulin patch pump, the A7+TouchCare (Medtrum), compared with the Omnipod system. METHODS: This multicenter, randomized, open-label, controlled study enrolled 100 adult patients with type 1 or type 2 diabetes mellitus (A1C ≥ 6.5% and ≤ 9.5%, i.e., 48 to 80 mmol/mol) who were assigned with the Omnipod or with the A7+TouchCare pump for 3 months. The primary study outcome was the glucose management indicator (GMI) calculated with continuous glucose monitoring (CGM). RESULTS: Premature withdrawals occurs respectively in 2 and 9 participants in the Omnipod and TouchCare groups. In the Per Protocol analysis, the difference in GMI between groups was 0.002% (95% confidence interval -0.251; 0.255). The non-inferiority was demonstrated since the difference between treatments did not overlap the pre-defined non-inferiority margin (0.4%). There was no significant difference in CGM parameters between groups. On average, patients in both groups were satisfied/very satisfied with the insulin pump system. Patients preferred Omnipod as an insulin management system and especially the patch delivery system but preferred the A7+TouchCare personal diabetes manager to control the system. CONCLUSIONS: This study showed that the A7+TouchCare insulin pump was as efficient as the Omnipod pump in terms of performance and satisfaction. CLINICAL TRAIL REGISTRATION: The study was registered in the ClinicalTrials.gov protocol register (NCT04223973).

First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data.

BACKGROUND: DBLG1 (Diabeloop Generation 1) stands as one of the five commercially available closed-loop solution worldwide for patients with type 1 diabetes as of 2023. Our aim was to provide an overview of all data obtained with this system regarding outcomes and populations, with an emphasis on interoperability. METHODS: This report includes all available sources of data (three randomized control trials and five surveys on real-life data). Collection ran from March 3, 2017 to April 30, 2022. RESULTS: We gathered data from 6859 adult patients treated with closed-loop from three to 12 months. Overall, all sources of data showed that time in range (TIR) 70 to 180 mg/dL, starting from 47.4% to 56.6%, improved from 12.2 to 17.3 percentage points. Time in hypoglycemia was reduced by 48% in average (range: 26%-70%) and reached a level of 1.3% in the largest and most recent cohort. In patients with excessive time in hypoglycemia at baseline (≥5%), closed-loop allowed a reduction in time below range (TBR) by 59%. The comparison of days with declared physical activity versus days without physical activity did not show differences in TBR. The improvement in TIR observed with three different pump systems (Vicentra Kaleido, n = 117; Sooil Dana-I, n = 84; and Roche Insight, n = 6684) ranged from 15.4 to 17.3 percentage points. DISCUSSION: These data obtained in different European countries were consistent throughout all reports, showing that this closed-loop system is efficient (high improvement in TIR), safe (remarkably low level of TBR), and interoperable (three pump settings so far).

Early origins of metabolic and overall health in young adults: An outcome-wide analysis in a general cohort population.

INTRODUCTION: Long-term consequences of impaired fetal growth are well documented for cardiometabolic outcomes. We propose an outcome-wide analysis of the association between birth weight (BW) and long-term health in a large contemporary adult cohort. METHODS: The study included 73,315 participants under 60 years with a reliable BW from the French nationwide Constances cohort. Low and high BW (LBW/HBW) were defined as BW<10th and >90th of sex-specific percentiles. Associations between BW and outcomes were analyzed with a sex-stratified modified Poisson regression adjusted for the participant's age, maternal health history, geographical origins, and parents' occupation. RESULTS: Mean BW (10th -90th percentile) was 3390 g (2800-4000) for men and 3247g (2680-3820) for women. In men, LBW was associated with (RR [CI95]): fasting glucose impairment (1.33 [1.16;1.52]); hypertriglyceridemia (1.27 [1.17;1.37]); high blood pressure (HBP) (1.15 [1.07;1.24]); non-alcoholic fatty liver disease NAFLD (1.13 [1.02;1.24]); high LDL-cholesterol (1.12 [1.05;1.21]); anxiety (1.12 [1.01;1.24]) and depression (1.09 [1.00;1.18]). HBW was associated with obesity (1.21 [1.08;1.35]). In women, LBW was associated with fasting glucose impairment (1.31 [1.12;1.54]); HBP (1.27 [1.16;1.4]); hypertriglyceridemia (1.20 [1.05;1.36]); anxiety (1.10 [1.03;1.17]); and asthma (1.09 [1;1.19}). HBW was associated with obesity (1.24 [1.13;1.36]) and NAFLD (1.20 [1.06;1.37). LBW and HBW were associated with a lesser likelihood of tertiary education attainment in both sexes. Participants' education level was a significant partial mediator of the association between LBW and outcomes. CONCLUSION: Extreme BW is associated with long-term health. It should be considered in the personalized prevention of cardiometabolic, respiratory, and mental health conditions in adulthood, especially in socio-economically disadvantaged populations.

Impact of diabetes on COVID-19 prognosis beyond comorbidity burden: the CORONADO initiative.

AIMS/HYPOTHESIS: Diabetes has been recognised as a pejorative prognostic factor in coronavirus disease 2019 (COVID-19). Since diabetes is typically a disease of advanced age, it remains unclear whether diabetes remains a COVID-19 risk factor beyond advanced age and associated comorbidities. We designed a cohort study that considered age and comorbidities to address this question. METHODS: The Coronavirus SARS-CoV-2 and Diabetes Outcomes (CORONADO) initiative is a French, multicentric, cohort study of individuals with (exposed) and without diabetes (non-exposed) admitted to hospital with COVID-19, with a 1:1 matching on sex, age (±5 years), centre and admission date (10 March 2020 to 10 April 2020). Comorbidity burden was assessed by calculating the updated Charlson comorbidity index (uCCi). A predefined composite primary endpoint combining death and/or invasive mechanical ventilation (IMV), as well as these two components separately, was assessed within 7 and 28 days following hospital admission. We performed multivariable analyses to compare clinical outcomes between patients with and without diabetes. RESULTS: A total of 2210 pairs of participants (diabetes/no-diabetes) were matched on age (mean±SD 69.4±13.2/69.5±13.2 years) and sex (36.3% women). The uCCi was higher in individuals with diabetes. In unadjusted analysis, the primary composite endpoint occurred more frequently in the diabetes group by day 7 (29.0% vs 21.6% in the no-diabetes group; HR 1.43 [95% CI 1.19, 1.72], p<0.001). After multiple adjustments for age, BMI, uCCi, clinical (time between onset of COVID-19 symptoms and dyspnoea) and biological variables (eGFR, aspartate aminotransferase, white cell count, platelet count, C-reactive protein) on admission to hospital, diabetes remained associated with a higher risk of primary composite endpoint within 7 days (adjusted HR 1.42 [95% CI 1.17, 1.72], p<0.001) and 28 days (adjusted HR 1.30 [95% CI 1.09, 1.55], p=0.003), compared with individuals without diabetes. Using the same adjustment model, diabetes was associated with the risk of IMV, but not with risk of death, within 28 days of admission to hospital. CONCLUSIONS/INTERPRETATION: Our results demonstrate that diabetes status was associated with a deleterious COVID-19 prognosis irrespective of age and comorbidity status. TRIAL REGISTRATION: ClinicalTrials.gov NCT04324736.

Association between birth weight, preterm birth, and nonalcoholic fatty liver disease in a community-based cohort.

BACKGROUND AND AIMS: The association between birth weight (BW) and metabolic outcomes has been described since the 1980s but NAFLD has been rarely studied. This study aimed to investigate the association between BW and NAFLD occurrence in adult subjects. APPROACH AND RESULTS: The study population consisted of participants from the French nationwide Constances cohort from 2012 to 2019. Participants with a history of chronic viral hepatitis or excessive alcohol consumption were excluded. Noninvasive diagnosis of NAFLD and fibrosis was performed using a combination of the Fatty Liver Index (FLI) and the Forns Index. The relationship between BW and NAFLD was analyzed with a sex-stratified logistic regression model adjusted for sociodemographic parameters, lifestyle, and birth term, whereas liver fibrosis was analyzed with a sex-stratified linear regression model. In total, 55,034 individuals with reliable BW were included (43% men, mean age: 38 years). NAFLD (FLI ≥ 60) was present in 5530 individuals (10%). Multivariate logistic regression showed a significant U-shaped relationship between BW and NAFLD, with no significant interaction with sex. A significant and slightly decreasing association was found between BW and Forns Index (ß = -0.05; p = 0.04). Premature birth (OR, 1.23; 95% CI, 1.03-1.48 for birth between 33 and 37 weeks versus ≥ 37 weeks) was associated with NAFLD, with a significant direct effect of premature birth, and without an indirect effect of low BW in mediation analysis. Forns Index was not significantly higher in participants with preterm birth compared to full-term birth. CONCLUSIONS: This large prospective adult-based cohort confirms the relationship between BW and NAFLD occurrence.

Factors Associated With Insulin Pump Discontinuation in Adults With Diabetes: A Time-to-Invent Analysis and Prediction Model.

OBJECTIVE: Insulin pump discontinuation has mostly been studied in children and adolescents living with diabetes. We aimed to assess the rate of insulin pump continuation in a population of adult patients with diabetes, at 18 months after initiation; determine the factors associated with pump discontinuation; and develop a simple prediction model. METHODS: This single-center, retrospective study included all adult patients with type 1 diabetes or type 2 diabetes who started insulin pump treatment between January 2015 and June 2018. The exclusion criteria were pregnancy, short-term pregnancy plans, and insulin pump discontinuation within the previous 6 months. The probability of insulin pump continuation after 18 months was estimated using the Kaplan-Meier method. Factors associated with insulin pump discontinuation were studied using a Cox regression model, and an exponential model was built for prediction purposes. RESULTS: The study included 315 patients. The mean age was 41 years, the mean duration of diabetes was 16 years, 50% were men, 74% had type 1 diabetes, and the mean hemoglobin A1c level was 9.1% (76 mmol/mol). After 18 months, the rate of insulin pump continuation was 0.80 (95% Confidence Interval (CI), 0.76-0.85). By multivariate analysis, the occurrence of severe hypoglycemia in the previous year was associated with insulin pump discontinuation (hazard ratio, 2.42; 95% CI, 1.30-4.51), while other factors did not reach statistical significance. CONCLUSION: Insulin pump discontinuation occurred in 20% of patients at 18 months after initiation and was mainly associated with a recent history of severe hypoglycemia. The type of diabetes and glycemic control at baseline were not associated with treatment discontinuation.

The switch from rapid-acting to concentrated regular insulin improves glucose control in type 2 diabetes patients on pump therapy: A cohort survey.

BACKGROUND: To evaluate the impact of switching from U-100 to U-500 insulin in patients with type 2 diabetes mellitus (T2DM) uncontrolled with continuous subcutaneous insulin infusion (CSII) by pump. METHODS: We retrospectively collected data from patients with T2DM, treated by U-100 CSII, who were switched to U-500 regular insulin where haemoglobin A1c (HbA1c) was >8% and/or insulin total daily dose (TDD) was >100 UI/d. Data collection from patient medical records included HbA1c, lipid levels, liver biomarkers, weight, TDD, declared hypoglycaemic episodes and measured by continuous glucose monitoring (CGM). RESULTS: Sixty-five patients were included, aged 63.9 ± 8.6 years, insulin pump since 3.7 ± 3 years, TDD 186 ± 52 U/day, body mass index 39.4 ± 5.3 kg/m², HbA1c 9.03 ± 1.6%. After switching to U-500 insulin, HbA1c dropped by -0.96% (P < 0.0001) at one year with the effect maintained at three years (- 0.95%, P < 0.01). A subgroup analysis (n=42/65) using a severity score which covered the three previous years on U-100 and the next three years on U-500 insulin confirmed the latter's efficacy. Body weight increased by + 4.8 kg and TDD by 16% at three years. Declared non-severe hypoglycaemia increased significantly three- to four-fold during follow up, but % time-below-range at six months did not differ between the two treatments. Baseline HbA1c correlated with improved glucose control with U-500. CONCLUSIONS: U-100 to U-500 insulin switch improves glucose control in CSII T2DM patients, especially with high baseline HbA1c. Use of concentrated insulin in pumps may represent an advance in the strategy for treating T2DM insulin resistant states with uncontrolled hyperglycaemia after a switch from multiple daily injections to pump therapy.

Short course corticosteroid treatment and closed-loop insulin delivery system: The experience of the DBLG1 pre-launch.

No abstract (brief report).

COVID-19 pandemic lockdown in young people with type 1 diabetes: Positive results of an unprecedented challenge for patients through telemedicine and change in use of continuous glucose monitoring.

There has been little data published related to glucose control in adolescents and young adults with type 1 diabetes (T1D) during lockdown, but rarely focusing on telemedicine's role. During this unpreceded period, glucose control and self-monitoring improved in our young patients, with better results associated with telemedicine.

Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study.

OBJECTIVE: Male sex is one of the determinants of severe coronavirus diseas-e-2019 (COVID-19). We aimed to characterize sex differences in severe outcomes in adults with diabetes hospitalized for COVID-19. METHODS: We performed a sex-stratified analysis of clinical and biological features and outcomes (i.e. invasive mechanical ventilation (IMV), death, intensive care unit (ICU) admission and home discharge at day 7 (D7) or day 28 (D28)) in 2380 patients with diabetes hospitalized for COVID-19 and included in the nationwide CORONADO observational study (NCT04324736). RESULTS: The study population was predominantly male (63.5%). After multiple adjustments, female sex was negatively associated with the primary outcome (IMV and/or death, OR: 0.66 (0.49-0.88)), death (OR: 0.49 (0.30-0.79)) and ICU admission (OR: 0.57 (0.43-0.77)) at D7 but only with ICU admission (OR: 0.58 (0.43-0.77)) at D28. Older age and a history of microvascular complications were predictors of death at D28 in both sexes, while chronic obstructive pulmonary disease (COPD) was predictive of death in women only. At admission, C-reactive protein (CRP), aspartate amino transferase (AST) and estimated glomerular filtration rate (eGFR), according to the CKD-EPI formula predicted death in both sexes. Lymphocytopenia was an independent predictor of death in women only, while thrombocytopenia and elevated plasma glucose concentration were predictors of death in men only. CONCLUSIONS: In patients with diabetes admitted for COVID-19, female sex was associated with lower incidence of early severe outcomes, but did not influence the overall in-hospital mortality, suggesting that diabetes mitigates the female protection from COVID-19 severity. Sex-associated biological determinants may be useful to optimize COVID-19 prevention and management in women and men.

No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial.

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system in controlling the hypoglycaemia induced by physical activity (PA) in real-life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P < .0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P < .0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real-life conditions, the use of DBLG1 avoids PA-induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit.