Mesure continue du glucose (ce système a-t-il répondu aux attentes du patient dans la prise en charge de son diabète ?)

La mesure en continu du glucose (MCG) avec affichage en temps réel a déjà prouvé son efficacité sur l équilibre métabolique en diminuant l HbA1c et la variabilité glycémique sans augmenter le nombre d hypoglycémies. L objectif principal de cette étude monocentrique, rétrospective et prospective, est d évaluer les attentes initiales des patients équipés d un capteur et d analyser le service rendu à partir d un questionnaire. Les objectifs secondaires sont d étudier après trois mois d utilisation, les changements de comportements du patient et les conséquences métaboliques (HbA1c), ainsi que le nombre d hypoglycémies sévères avec l utilisation de l arrêt automatique de la pompe. Entre avril 2009 et juillet 2012, au CHU de Grenoble, 35 patients adultes diabétiques de type 1, sous pompe à insuline externe pour 33 d entre eux, avec une HbA1c initiale moyenne de 8,1 +- 1,4%, ont été équipés de capteurs. On observe une satisfaction prédominante sur la prévention des hypoglycémies (100% des patients) puis sur le contrôle des hyperglycémies (88%). 51% des patients ont abandonné le système, lié en grande partie à l anxiété générée par les alertes et aux difficultés techniques. Après 3 mois d utilisation, le nombre moyen de bolus par jour a augmenté de 56% (p = 0,06) le temps d arrêt temporaire moyen de la pompe a également augmenté de 34% (p = 0,09). La baisse moyenne de l HbA1c observée à 3 mois est de 0,31% (n=23) et de 1,15% pour les patients ayant une HbA1c > 9%. Sur les 17 patients équipés de l arrêt automatique de pompe, aucun n a eu d hypoglycémie sévère. Ce système est donc une aide pour le patient s il est associé à un programme d éducation thérapeutique spécifique.Continuous glucose monitoring proved its effectiveness in reducing HbA1c and glycemic variability without increasing hypoglycemia number. The main objective of this single-center retrospective and prospective study is to assess the initial expectations of patients fitted with a sensor and analyze this service from a questionnaire. Secondary objectives consist in evaluating after three months of use patient's behavioral changes, metabolic consequences (HbA1c) and severe hypoglycemia number with the use of automated insulin suspension. Between April 2009 and July 2012, in Grenoble University Hospital, 35 adult patients with type 1 diabetes were equipped of sensors. 33 of them have been treated with continuous subcutaneous insulin infusion, with a mean baseline HbA1c of 8.1 +- 1.4%. The predominant satisfaction is hypoglycemia prevention (100% of patients) and secondarily hyperglycemia control (88%). 51% of patients have dropped out, mostly related to the anxiety generated by alerts and technical difficulties. After 3 months of use the average number of bolus per day increased by 56% (p = 0.06). The temporary insulin suspension was also increased by 34% (p = 0.09). The mean decrease in HbA1c observed at 3 months was 0.31% (n = 23) and 1.15% for patients with HbA1c > 9%. None of the 17 patients fitted with automated insulin suspension had severe hypoglycemia. Therefore, this system can help the patient when it is associated with a specific therapeutic education program.GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF

Combining Glucose Monitoring and Insulin Infusion in an Integrated Device: A Narrative Review of Challenges and Proposed Solutions.

The introduction of automated insulin delivery (AID) systems has enabled increasing numbers of individuals with type 1 diabetes (T1D) to improve their glycemic control largely. However, use of AID systems is limited due to their complexity and costs associated. The user must wear both a continuously monitoring glucose system and an insulin infusion pump. The glucose sensor and the insulin catheter must be inserted at two different body sites using different insertion devices. In addition, the user must pair and manage the different systems. These communicate with the AID software implemented on the pump or on a third device such as a dedicated display device or smart phone application. These components might be developed and commercialized by different manufacturers, which in turn can cause difficulties for patients seeking technical support. A possible solution to these challenges would be to integrate the glucose sensor and insulin catheter into a single device. This would allow the glucose sensor and insulin catheter to be inserted simultaneously, eliminating the need for pairing, and simplifying system management. In recent years, different technologies have been developed and evaluated in clinical investigations that combine the glucose sensor and the insulin catheter in one platform. The consistent finding of all these studies is that integration has no adverse effect on insulin infusion and glucose measurements provided that certain conditions are met. In this review, we discuss the perceived challenges of such an approach and discuss possible solutions that have been proposed

Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study

AIMS/HYPOTHESIS: This is an update of the results from the previous report of the CORONADO (Coronavirus SARS-CoV-2 and Diabetes Outcomes) study, which aims to describe the outcomes and prognostic factors in patients with diabetes hospitalised for coronavirus disease-2019 (COVID-19). METHODS: The CORONADO initiative is a French nationwide multicentre study of patients with diabetes hospitalised for COVID-19 with a 28-day follow-up. The patients were screened after hospital admission from 10 March to 10 April 2020. We mainly focused on hospital discharge and death within 28 days. RESULTS: We included 2796 participants: 63.7% men, mean age 69.7 ± 13.2 years, median BMI (25th-75th percentile) 28.4 (25.0-32.4) kg/m(2). Microvascular and macrovascular diabetic complications were found in 44.2% and 38.6% of participants, respectively. Within 28 days, 1404 (50.2%; 95% CI 48.3%, 52.1%) were discharged from hospital with a median duration of hospital stay of 9 (5-14) days, while 577 participants died (20.6%; 95% CI 19.2%, 22.2%). In multivariable models, younger age, routine metformin therapy and longer symptom duration on admission were positively associated with discharge. History of microvascular complications, anticoagulant routine therapy, dyspnoea on admission, and higher aspartate aminotransferase, white cell count and C-reactive protein levels were associated with a reduced chance of discharge. Factors associated with death within 28 days mirrored those associated with discharge, and also included routine treatment by insulin and statin as deleterious factors. CONCLUSIONS/INTERPRETATION: In patients with diabetes hospitalised for COVID-19, we established prognostic factors for hospital discharge and death that could help clinicians in this pandemic period. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04324736

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

BackgroundA composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.MethodsWe assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.ResultsThe analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.ConclusionThe GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome associated with COVID-19: An Emulated Target Trial Analysis.

RATIONALE: Whether COVID patients may benefit from extracorporeal membrane oxygenation (ECMO) compared with conventional invasive mechanical ventilation (IMV) remains unknown. OBJECTIVES: To estimate the effect of ECMO on 90-Day mortality vs IMV only Methods: Among 4,244 critically ill adult patients with COVID-19 included in a multicenter cohort study, we emulated a target trial comparing the treatment strategies of initiating ECMO vs. no ECMO within 7 days of IMV in patients with severe acute respiratory distress syndrome (PaO2/FiO2 <80 or PaCO2 ≥60 mmHg). We controlled for confounding using a multivariable Cox model based on predefined variables. MAIN RESULTS: 1,235 patients met the full eligibility criteria for the emulated trial, among whom 164 patients initiated ECMO. The ECMO strategy had a higher survival probability at Day-7 from the onset of eligibility criteria (87% vs 83%, risk difference: 4%, 95% CI 0;9%) which decreased during follow-up (survival at Day-90: 63% vs 65%, risk difference: -2%, 95% CI -10;5%). However, ECMO was associated with higher survival when performed in high-volume ECMO centers or in regions where a specific ECMO network organization was set up to handle high demand, and when initiated within the first 4 days of MV and in profoundly hypoxemic patients. CONCLUSIONS: In an emulated trial based on a nationwide COVID-19 cohort, we found differential survival over time of an ECMO compared with a no-ECMO strategy. However, ECMO was consistently associated with better outcomes when performed in high-volume centers and in regions with ECMO capacities specifically organized to handle high demand. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Improving diabetes management with electronic health records and patients' health records.

International audienceThe lack of patient engagement and clinical inertia both contribute to suboptimal diabetes care. However, both obstacles are amenable to informatics- and Internet-based interventions. The use of electronic medical records (EMRs) is now established as being useful for improving diabetes care. Intelligent records that integrate computerized decision-support systems are now able to recommend care protocols tailored to risk levels. Web-based personal health record (PHR) systems, shared with healthcare providers, could also provide added value by promoting self-management of the behaviours related to diabetes. These Web-based programmes include patients' access to EMRs, uploading of glucose monitoring results, a glucose diary, secure e-mail with providers, manual or automated feedback on blood glucose readings and other risk factors, an educational website, and an online diary for entering personal information on exercise, diet and medication. The integration of Web-based patients' systems into the EMR used by physicians is the next frontier. In addition, the input from "smartphones" that are able to provide real-time support to patients could contribute to the reorganization of diabetes care. Convincing data on HbA(1c) improvements with such systems are available for type 2 diabetes, but are still equivocal for type 1 diabetes. Obstacles include patients' compliance with the technology, their ergonomic design and the need to reimburse providers for their care. Designing appropriate electronic tools and tailoring them to the conditions in France merits our attention

L'insulinothérapie fonctionnelle contribue à améliorer la variabilité glycémique mesurée par l ADRR (Average Daily Risk Range) chez le diabétique de type I (étude VARIAFIT)

Objectifs : L HbA1c explique 20% seulement du risque de rétinopathie dans le DCCT. Le rôle de la variabilité glycémique (VG) a été suspecté. Chez le diabétique de type 2, cette dernière génère un stress oxydant. Chez le diabétique de type 1, l insulinothérapie fonctionnelle (IF) prétend réduire les fluctuations glycémiques. Notre objectif est a) de montrer que l IF permet de réduire la VG chez le DT1, b) d identifier un marqueur pertinent de VG, c) d évaluer l impact de la VG sur le stress oxydant et l inflammation. Matériels et méthodes : mesure de la VG d après la mémoire du lecteur glycémique selon 4 indicateurs (MAGE, LBGI, LI, ADRR) chez 30 patients DT1 stables, candidats à un stage d éducation thérapeutique à l IF, à 0, 3 et 6 mois ; dosage des 8-isoPGF2a, LTE4 et TXB2. Résultats : MAGE diminue à M3 dans le groupe excédant initialement 150 mg/dl (180 +- 10 vs 144 +- 39, p=0.016) sans persistance de l amélioration à M6. ADRR diminue entre M0 et M6 (30.6 +- 14.5 vs 23 +- 11.3, p=0.018) et entre M3 et M6 (28.7 +- 10.4 vs 23 +- 11.3, p=0.041). Dans le groupe excédant initialement 40, ADRR diminue à M3 (42.2 +- 9.7 vs 35.5 +- 5.6, p=0.018) avec persistance de l amélioration à M6. LI et LBGI s améliorent non significativement à M3, tandis que le BMI diminue à M6 (23.9 +- 3.2 vs 23.4 +- 2.9 kg/m2, p=0.003). Les TXB2 diminuent à M6 (832 +- 625 vs 633 +- 972 pg/mg, p=0.048), sans corrélation aux marqueurs de VG . La production des 8-isoPGF2a ne change pas, ni l HbA1c. Conclusion : A HbA1c stable, l IF est associée à une amélioration de la VG. L ADRR, principal indicateur à la mettre en évidence, et séduisant par son concept mathématique et sa période de recueil cliniquement pertinente (15 jours), se prête à une utilisation clinique plus large. Le retentissement physiopathologique de la VG chez le DT1 demeure équivoque.Objective: HbA1c explains only 20% of the retinopathy risk in the DCCT study. Glycemic variability (GV) has been suspected to be another factor. In type 2 diabetes patients, GV causes oxidative stress. In type 1 diabetes patients, functional insulinotherapy (FI) claims to reduce glycemic variations. Our objective is a) to prove that FI reduces GV in type 1 diabetes patients, b) to identify a relevant indicator of GV, c) to assess the impact of GV on oxidative stress and inflammation. Material and methods: Calculation of 4 glycaemia variability indicators (MAGE, LBGI, LI, ADRR) using the measures of GV from the glucose meter at 0, 3 months and 6 months, in 30 patients with type 1 diabetes, attending a functional insulinotherapy class. 8-isoPGF2a, LTE4 and TXB2 levels are also assessed. Results: MAGE decreases at M3 in patients initially over 150 mg/dl (180 +- 10 vs 144 +- 39, p=0.016) but this improvement is no longer observed at M6. ADRR decreases between M0 and M6 (30.6 +- 14.5 vs 23 +- 11.3, p=0.018) and between M3 and M6 (28.7 +- 10.4 vs 23 +- 11.3, p=0.041). ADRR decreases at M3 in patients initially over 40 (42.2 +- 9.7 vs 35.5 +- 5.6, p=0.018) and the change is still observed at M6. LI and LBGI are improved non-significantly at M3 while BMI decreases at M6 (23.9 +- 3.2 vs 23.4 +- 2.9 kg/m2, p=0.003). The level of TXB2 decreases at M6 (832 +- 625 vs 633 +- 972 pg/mg, p=0.048), but TBX2s are not correlated to GV indicators. No variation in 8-isoPGF2alpha or HbA1c occurred. Conclusion: In patients with stable HbA1c, FI is associated with an improvement of glycemic variability. ADRR is the most powerful indicator. Its enticing mathematical concept and its relevant data-collection phase (15 days) allow a broad range of clinical uses. The pathophysiological effects of GV in type 1 diabetes remain unclear.GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Conception et réalisation d un outil éducatif multimédia destiné au patient diabétique de type 1 (le programme IndiGO)

L évolution rapide des nouveaux médias ouvre des perspectives nouvelles en éducation thérapeutique du patient (ETP). La démocratisation de l utilisation d Internet permettrait un plus large accès du patient aux programmes éducatifs. De plus, le programme étant dispensé de manière plus ludique, par le truchement des outils multimédias, on peut penser que cette nouvelle façon d aborder les connaissances permettrait au patient de mettre en jeu des processus cognitifs non mobilisés habituellement. L absence de support Internet francophone existant pour l ETP nous a conduit à concevoir un outil éducatif ciblant les patients diabétiques de type 1, accessible en auto-apprentissage et répondant du mieux possible aux demandes réelles des patients : le programme IndiGO. Ce programme a pour objectif de permettre au patient d identifier par lui même ses réels besoins de soins, tout en apportant les connaissances théoriques qui lui sont nécessaires et en lui proposant une utilisation pratique immédiate des ressources proposées. Le programme IndiGO est désormais en cours de réalisation. Nous présentons dans ce manuscrit son rationnel, les bases conceptuelles qui ont étayé sa réalisation, les modalités organisationnelles du comité de pilotage du projet, le contenu prévisionnel du programme, et l état actuel de sa réalisation. Sa version finale, qui sera proposée via Internet devra faire l objet d une étude scientifique afin d en estimer les bénéfices pour les patients. Par son mode de délivrance, le programme IndiGO participe de l essor actuel de la télémédecine et de l éducation thérapeutique dans la prise en charge des pathologies chroniques.GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF