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Master Thesis

Survenue d'évènements indésirables graves chez les sujets âgés diabétiques de type 2 pré-fragiles et fragiles

Abstract : Introduction: Diabetes is an inflammatory condition which promotes the physiological aging process which can lead to a state of fragility. The glycemic balance is controlled by measuring glycated hemoglobin, however few studies have evaluated the link between glycated hemoglobin and serious adverse event, allowing to define threshold values protecting or favoring the occurrence of serious adverse events (SAE ). In this study, the main objective is to investigate the link between glycated hemoglobin and the occurrence of a serious adverse event in patients of at least 70 years of age with type 2 diabetes. The secondary objective is to study the relationship between frailty and the occurrence of a serious adverse event. Method: Post hoc study of the MIDFRAIL project, a multicenter randomized cluster clinical trial and of the SENSOLE study, a non-randomized sub-study of the European MIDFRAIL project. The participants were diabetic, pre-frail or frail, and at least 70 years old. Adverse events were recorded on an SAE sheet during SENSOLE and MI-FRAIL follow-ups, then they were collected if they fell within the definition of an SAE. Three classes of HbA1c were formed, [6.5% -7.5%], [7.6% -8.5%],> 8.5%, the class [7.6% - 8.5 %] being the reference. Statistical analyzes were performed with BiostatTGV and Excel 2016. Results: There were 61.2% men and the mean age was 78.76 ± 5.31 years, gender. 49% of patients (n = 24) had a serious adverse event. The most common are infections, blood sugar imbalances and cardiovascular events. Comparison of classes 1 and 2 between 0-2 months from inclusion shows p = 0.47, OR 0.5182 95% CI [0.0982; 2.594], comparison of classes 2 and 3, p = 0.347, OR at 0.3619 95% CI [0.0254; 3.3147]. Analysis of the data at at least 6 months of follow-up, between classes 1 and 2 and 2 and 3 do not show a statistical link with respectively a p = 0.671, p = 0.087. We did not find a statistical link between EIG and frailty status with a p at 0.131. Conclusion: The present study did not demonstrate a statistical link between the occurrence of a serious adverse event, HbA1c and frailty possibly due to lack of potency. All the same, these results remain encouraging and could be reassessed on a larger scale.
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Submitted on : Thursday, September 2, 2021 - 5:37:48 PM
Last modification on : Tuesday, February 8, 2022 - 2:17:12 PM


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Priscilla Sildillia Jacques. Survenue d'évènements indésirables graves chez les sujets âgés diabétiques de type 2 pré-fragiles et fragiles. Endocrinologie et métabolisme. 2020. ⟨dumas-03332494⟩



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