Evidence-Based Guideline for the management of osteoporosis in men.

Historically, osteoporosis has been viewed as a disease of women, with research, trials of interventions and guidelines predominantly focused as such. It is apparent, however, that this condition causes a substantial health burden in men also, and that its assessment and management must ultimately be addressed across both sexes. In this article, an international multidisciplinary working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases presents GRADE-assessed recommendations for the diagnosis, monitoring and treatment of osteoporosis in men. The recommendations are based on a comprehensive review of the latest research related to diagnostic and screening approaches for osteoporosis and its associated high fracture risk in men, covering disease burden, appropriate interpretation of bone densitometry (including the use of a female reference database for densitometric diagnosis in men) and absolute fracture risk, thresholds for treatment, and interventions that can be used therapeutically and their health economic evaluation. Future work should specifically address the efficacy of anti-osteoporosis medications, including denosumab and bone-forming therapies.

[Drug shortages : a fatality ?] / Médicaments indisponibles : une fatalité ?

In recent years, the number of drug shortages has risen alarmingly both in Belgium and internationally. Between 2010 and 2020, the number of reported shortages is almost 27 times higher, according to the French Agency for the Safety of Medicines and Health Products. A recent survey conducted by the European Association of Hospital Pharmacists showed that 95 % of hospital pharmacists consider drug shortages to be a major problem. The drug classes most affected include anti-infectives, analgesics and anaesthetics. The sudden and unpredictable occurrence of drug shortages has a negative impact on the daily lives of healthcare professionals and patients. Doctors are sometimes forced to prescribe alternative treatments that are considered less effective or even less well tolerated. These alternatives make it more difficult for patients to adhere to their treatment and generate an additional risk of medication errors. There are several possible solutions to minimize these shortages: relocating production sites to Europe, imposing penalties on offending companies, adopting a common European policy for managing shortages of medicines of major therapeutic interest,... As a corollary to these proposals, legal texts have been adopted to regulate and guarantee the supply of medicines in Belgium.

Depuis ces dernières années, le nombre de médicaments indisponibles a augmenté de manière inquiétante, tant en Belgique qu'au niveau international. Entre 2010 et 2020, le nombre de pénuries signalées sont près de 27 fois plus élevées, selon l'Agence Française de Sécurité du Médicament et des Produits de Santé. Une récente enquête réalisée par l'Association Européenne des Pharmaciens Hospitaliers a montré que 95 % des pharmaciens hospitaliers considèrent ces pénuries médicamenteuses comme un problème majeur. Parmi les classes médicamenteuses les plus touchées se retrouvent, notamment, les anti-infectieux, les analgésiques et les agents anesthésiques. De survenue soudaine et imprévisible, les ruptures entachent le quotidien tant des professionnels de la santé que des patients. Les médecins sont, parfois, contraints de prescrire des traitements alternatifs jugés moins efficaces, voire moins bien tolérés. Ces alternatives complexifient l'adhérence thérapeutique du patient en générant un risque supplémentaire d'erreur médicamenteuse. Pour pallier ces indisponibilités, certaines pistes de solutions peuvent être dégagées : relocaliser en Europe les sites de production, sanctionner les firmes fautives, adopter une politique européenne commune de gestion des pénuries de médicaments d'intérêt thérapeutique majeur,… En corollaire de ces propositions, des textes juridiques ont été édictés afin d'encadrer et de garantir l'approvisionnement en médicaments en Belgique.

[Gliflozins and finerenone: what are the prospects for their combination?] / Gliflozines et finérénone : quelles perspectives pour leur association?

Chronic kidney disease is a common complication of diabetes. Progressive deterioration of renal function is responsible for an increased risk of cardiovascular diseases. The end-stage renal disease with the vital recourse to dialysis sessions remains a major burden for the patients as well as for the society given the major cost of this treatment. Recently, two classes of drugs have demonstrated significant benefits in terms of cardio-renal protection: SGLT2 inhibitors (gliflozins) and finerenone, a selective nonsteroidal mineralo-receptor antagonist. Given their different mechanisms of action, a combination of the two pharmacological classes seems logical and promising based on a number of exploratory current analyses and considerations.

La maladie rénale chronique (MRC) est une complication fréquente liée à diverses pathologies dont le diabète. La dégradation progressive de la fonction rénale est responsable d'un risque accru de présenter des maladies cardiovasculaires. Son évolution terminale avec le recours vital à la dialyse reste un fardeau majeur pour les personnes qui en souffrent ainsi que pour la société compte tenu du coût qui en résulte. Récemment, deux classes médicamenteuses ont démontré des avantages significatifs en termes de protection cardiorénale : les inhibiteurs du SGLT2 (gliflozines) et la finérénone, un antagoniste sélectif non stéroïdien des récepteurs de l'aldostérone. Compte tenu de mécanismes d'action différents, leur combinaison semble logique et prometteuse sur la base de plusieurs analyses exploratoires.

Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. PURPOSE: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. METHODS: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. RESULTS: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. CONCLUSIONS: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.

[The placebo effect in functional disorders]. / Effet placebo dans les troubles fonctionnels.

Functional disorders are clinical entities corresponding to complaints mimicking diseases without a clearly identified organic substrate despite a rigorous history and clinical examination. Sometimes, complementary examinations are necessary to rule out an organic lesion that could explain the symptomatology. The notion of a diagnosis of exclusion is therefore very present. The physician must constantly re-evaluate the diagnosis of functional disorder in order not to «miss¼ a diagnosis with an organic cause.The treatment of these functional disorders is sometimes based on psychological treatment when a psychogenic dimension seems to be involved. This is not always the case. In such cases it is necessary to be able to consider a placebo approach with the hope that the placebo effect may improve the patient's condition. This article discusses the placebo effect in functional disorders without omitting to address ethical and philosophical considerations.

Les troubles fonctionnels sont des entités cliniques correspondant à des plaintes mimant des maladies sans substrat organique clairement identifié, malgré une anamnèse et un examen clinique rigoureux. Parfois, certains examens complémentaires sont nécessaires pour infirmer une lésion organique pouvant expliquer la symptomatologie. La notion de diagnostic d'exclusion est donc bien présente. Le praticien se doit de réévaluer sans cesse le diagnostic de trouble fonctionnel afin de ne pas «passer à côté¼ d'un diagnostic avec une cause organique. Le traitement de ces troubles fonctionnels repose parfois sur une prise en charge psychologique lorsqu'une dimension psychogène semble incriminée. Ce n'est pas toujours le cas. Il faut alors pouvoir être capable d'envisager une approche via des placebo en espérant que l'effet placebo puisse améliorer la condition du (de la) patient(e). Cet article décrit l'effet placebo dans les troubles fonctionnels, sans omettre d'aborder des notions éthiques et philosophiques.

Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Académique de Recherche et d'Expérimentation en Santé (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging.

In clinical trials, biochemical markers provide useful information on the drug's mode of action, therapeutic response and side effect monitoring and can act as surrogate endpoints. In pharmacological intervention development for sarcopenia management, there is an urgent need to identify biomarkers to measure in clinical trials and that could be used in the future in clinical practice. The objective of the current consensus paper is to provide a clear list of biochemical markers of musculoskeletal health and aging that can be recommended to be measured in Phase II and Phase III clinical trials evaluating new chemical entities for sarcopenia treatment. A working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposed classifying biochemical markers into 2 series: biochemical markers evaluating musculoskeletal status and biochemical markers evaluating causal factors. For series 1, the group agreed on 4 biochemical markers that should be assessed in Phase II or Phase III trials (i.e., Myostatin-Follistatin, Brain Derived Neurotrophic Factor, N-terminal Type III Procollagen and Serum Creatinine to Serum Cystatin C Ratio - or the Sarcopenia Index). For series 2, the group agreed on 6 biochemical markers that should be assessed in Phase II trials (i.e., the hormones insulin-like growth factor-1 (IGF-I), dehydroepiandrosterone sulphate, and cortisol, and the inflammatory markers C-reactive protein (CRP), interleukin-6 and tumor necrosis factor-α), and 2 in Phase III trials (i.e., IGF-I and CRP). The group also proposed optional biochemical markers that may provide insights into the mode of action of pharmacological therapies. Further research and development of new methods for biochemical marker assays may lead to the evolution of these recommendations.

Novel formulations of oral bisphosphonates in the treatment of osteoporosis.

Oral bisphosphonates are a key intervention in the treatment of osteoporosis and in reducing the risk of fragility fractures. Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms. This problem has led to the development of novel oral bisphosphonate formulations. Buffered, effervescent alendronate is dissolved in water and so seeks to reduce upper gastro-intestinal adverse events, and gastro-resistant risedronate aims to reduce the complexity of dosing procedure (e.g. fasting prior to consumption) whilst still maintaining the efficacy of fracture risk reduction. Clinical trials and real-world data have been employed to demonstrate some benefits in terms of reduced upper gastro-intestinal adverse events, adherence, persistence and health economic outcomes. This report describes the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores where oral bisphosphonates sit in current clinical practice guidelines, review their risk-benefit profile and the consequences of poor adherence before exploring novel oral bisphosphonate formulations and their potential clinical and health economic impact. Further research is required but there are signs that these novel, oral bisphosphonate formulations may lead to improved tolerance of oral bisphosphonates and thus, improved adherence and fracture outcomes.

Role of vitamin D supplementation in the management of musculoskeletal diseases: update from an European Society of Clinical and Economical Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) working group.

Vitamin D is a key component for optimal growth and for calcium-phosphate homeostasis. Skin photosynthesis is the main source of vitamin D. Limited sun exposure and insufficient dietary vitamin D supply justify vitamin D supplementation in certain age groups. In older adults, recommended doses for vitamin D supplementation vary between 200 and 2000 IU/day, to achieve a goal of circulating 25-hydroxyvitamin D (calcifediol) of at least 50 nmol/L. The target level depends on the population being supplemented, the assessed system, and the outcome. Several recent large randomized trials with oral vitamin D regimens varying between 2000 and 100,000 IU/month and mostly conducted in vitamin D-replete and healthy individuals have failed to detect any efficacy of these approaches for the prevention of fracture and falls. Considering the well-recognized major musculoskeletal disorders associated with severe vitamin D deficiency and taking into account a possible biphasic effects of vitamin D on fracture and fall risks, an European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) working group convened, carefully reviewed, and analyzed the meta-analyses of randomized controlled trials on the effects of vitamin D on fracture risk, falls or osteoarthritis, and came to the conclusion that 1000 IU daily should be recommended in patients at increased risk of vitamin D deficiency. The group also addressed the identification of patients possibly benefitting from a vitamin D loading dose to achieve early 25-hydroxyvitamin D therapeutic level or from calcifediol administration.

Multimodal Multidisciplinary Management of Patients with Moderate to Severe Pain in Knee Osteoarthritis: A Need to Meet Patient Expectations.

Knee osteoarthritis (OA) is one of the most common and disabling medical conditions. In the case of moderate to severe pain, a single intervention may not be sufficient to allay symptoms and improve quality of life. Examples include first-line, background therapy with symptomatic slow-acting drugs for OA (SYSADOAs) or non-steroidal anti-inflammatory drugs (NSAIDs). Therefore, the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) performed a review of a multimodal/multicomponent approach for knee OA therapy. This strategy is a particularly appropriate solution for the management of patients affected by knee OA, including those with pain and dysfunction reaching various thresholds at the different joints. The multimodal/multicomponent approach should be based, firstly, on different combinations of non-pharmacological and pharmacological interventions. Potential pharmacological combinations include SYSADOAs and NSAIDs, NSAIDs and weak opioids, and intra-articular treatments with SYSADOAs/NSAIDs. Based on the available evidence, most combined treatments provide benefit beyond single agents for the improvement of pain and other symptoms typical of knee OA, although further high-quality studies are required. In this work, we have therefore provided new, patient-centered perspectives for the management of knee OA, based on the concept that a multimodal, multicomponent, multidisciplinary approach, applied not only to non-pharmacological treatments but also to a combination of the currently available pharmacological options, will better meet the needs and expectations of patients with knee OA, who may present with various phenotypes and trajectories.

[Focus on tirzepatide, a dual unimolecular GIP-GLP-1 receptor agonist in type 2 diabetes]. / Focus sur le tirzépatide, un double agoniste unimoléculaire GIP-GLP-1 dans le diabète de type 2.

Tirzepatide is a unimolecular dual agonist of both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which is developed as once-weekly injection for the treatment of type 2 diabetes. Because of the complementarity of action of the two incretins, tirzepatide showed, in a dose-dependent manner (5, 10 and 15 mg), a better efficacy (greater reduction in HbA1c and body weight) compared with placebo, basal insulin and two GLP-1 analogues (dulaglutide and semaglutide) in the SURPASS program. Its cardiovascular protection (versus dulaglutide) is currently tested in SURPASS-CVOT. Finally, studies for the treatment of obesity and metabolic associated fatty liver disease are also ongoing. Gastrointestinal tolerance of tirzepatide appears comparable to that of GLP-1 analogues, except more diarrhoea.

Le tirzépatide est un agoniste unimoléculaire double des récepteurs du polypeptide insulinotrope dépendant du glucose (GIP) et du Glucagon-Like Peptide-1 (GLP-1) développé, en injection hebdomadaire, pour le traitement du diabète de type 2. De par la complémentarité des 2 incrétines, il a montré, de façon dose-dépendante (5, 10 et 15 mg), une efficacité supérieure (plus forte réduction du taux d'HbA1c (hémoglobine glyquée) et du poids corporel) par rapport au placebo, à l'insuline basale et à 2 analogues du GLP-1 (dulaglutide et sémaglutide) dans le programme SURPASS. Sa protection cardiovasculaire (versus le dulaglutide) est actuellement testée dans SURPASS-CVOT. Enfin, des études sont en cours dans l'obésité et la stéatopathie hépatique. La tolérance digestive du tirzépatide est comparable à celle des analogues du GLP-1, hormis davantage de diarrhée.

[Impact of COVID-19 on telemedicine in diabetes management: the Belgian experience]. / Impact du Covid-19 sur la télémédecine en diabétologie : l'expérience belge.

We will briefly review the history of telemedicine. Then we will look at its various applications, including teleconsultation, which is only one part of telemedicine. Belgium had not evolved much in the field of teleconsultation. It was only during the COVID-19 pandemic that this possibility was quickly made available to caregivers, and therefore to patients. We will discuss how the Belgian authorities were able to speed up the possibility of using this branch of telemedicine. We will focus more specifically on the care of diabetic patients, particularly in our institution, the University Hospital of Liège in Belgium. Finally, we will discuss the limits and prospects of telemedicine, particularly in the field of diabetology.

Nous allons revoir brièvement l'historique de la télémédecine. Ensuite nous aborderons ses différentes applications, dont fait partie la téléconsultation, qui est une partie de la télémédecine. La Belgique n'avait que peu évolué en matière de téléconsultation. Il a fallu que la pandémie de Covid-19 arrive pour que cette possibilité soit rapidement offerte aux soignants, et donc aux patients. Nous aborderons comment les autorités belges ont pu accélérer la possibilité d'avoir recours à cette branche de la télémédecine. Nous nous focaliserons plus spécifiquement sur la prise en charge des patients diabétiques, en particulier dans notre institution, à savoir le CHU de Liège en Belgique. Enfin, nous aborderons les limites et les perspectives de la télémédecine, en particulier dans le domaine de la diabétologie.

Management of hand osteoarthritis: from an US evidence-based medicine guideline to a European patient-centric approach.

Hand osteoarthritis is the most common joint condition and is associated with significant morbidity. It is of paramount importance that patients are thoroughly assessed and examined when complaining of hand stiffness, pain, deformity or disability and that the patient's concerns and expectations are addressed by the healthcare professional. In 2019 the American College of Rheumatology and Arthritis Foundation (ACR/AF) produced guidelines which included recommendations for the treatment of hand osteoarthritis. An ESCEO expert working group (including patients) was convened and composed this paper with the aim to assess whether these guidelines were appropriate for the treatment of hand osteoarthritis therapy in Europe and whether they met with the ESCEO patient-centered approach. Indeed, patients are the key stakeholders in healthcare and eliciting the patient's preference is vital in the context of an individual consultation but also for informing research and policy-making. The patients involved in this working group emphasised the often-neglected area of aesthetic changes in hand osteoarthritis, importance of developing pharmacological therapies which can alleviate pain and disability and the need of the freedom to choose which approach (out of pharmacological, surgical or non-pharmacological) they wished to pursue. Following robust appraisal, it was recommended that the ACR/AF guidelines were suitable for a European context (as described within the body of the manuscript) and it was emphasised that patient preferences are key to the success of individual consultations, future research and future policy-making.

Management of patients at very high risk of osteoporotic fractures through sequential treatments.

Osteoporosis care has evolved markedly over the last 50 years, such that there are now an established clinical definition, validated methods of fracture risk assessment and a range of effective pharmacological agents. Currently, bone-forming (anabolic) agents, in many countries, are used in those patients who have continued to lose bone mineral density (BMD), patients with multiple subsequent fractures or those who have fractured despite treatment with antiresorptive agents. However, head-to-head data suggest that anabolic agents have greater rapidity and efficacy for fracture risk reduction than do antiresorptive therapies. The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) convened an expert working group to discuss the tools available to identify patients at high risk of fracture, review the evidence for the use of anabolic agents as the initial intervention in patients at highest risk of fracture and consider the sequence of therapy following their use. This position paper sets out the findings of the group and the consequent recommendations. The key conclusion is that the current evidence base supports an "anabolic first" approach in patients found to be at very high risk of fracture, followed by maintenance therapy using an antiresorptive agent, and with the subsequent need for antiosteoporosis therapy addressed over a lifetime horizon.

Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus.

PURPOSE: Real-time continuous glucose monitoring (RT-CGM) provides information on glycemic variability (GV), time in range (TIR), and guidance to avoid hypoglycemia, thereby complimenting HbA1c for diabetes management. We investigated whether GV and TIR were independently associated with chronic and acute diabetes complications. METHODS: Between September 2014 and January 2017, 515 subjects with type 1 diabetes using sensor-augmented pump therapy were followed for 24 months. The link between baseline HbA1c and CGM-derived glucometrics (TIR [70-180 mg/dL], coefficient of variation [CV], and SD) obtained from the first 2 weeks of RT-CGM use and the presence of complications was investigated. Complications were defined as: composite microvascular complications (presence of neuropathy, retinopathy, or nephropathy), macrovascular complications, and hospitalization for hypoglycemia and/or ketoacidosis. RESULTS: Individuals with microvascular complications were older (P < 0.001), had a longer diabetes duration (P < 0.001), a higher HbA1c (7.8 ± 0.9 vs 7.5 ± 0.9%, P < 0.001), and spent less time in range (60.4 ± 12.2 vs 63.9 ± 13.8%, P = 0.022) compared with those without microvascular complication. Diabetes duration (odds ratio [OR] = 1.12 [1.09-1.15], P < 0.001) and TIR (OR = 0.97 [0.95-0.99], P = 0.005) were independent risk factors for composite microvascular complications, whereas SD and CV were not. Age (OR = 1.08 [1.03-1.14], P = 0.003) and HbA1c (OR = 1.80 [1.02-3.14], P = 0.044) were risk factors for macrovascular complications. TIR (OR = 0.97 [0.95-0.99], P = 0.021) was the only independent risk factor for hospitalizations for hypoglycemia or ketoacidosis. CONCLUSIONS: Lower TIR was associated with the presence of composite microvascular complications and with hospitalization for hypoglycemia or ketoacidosis. TIR, SD, and CV were not associated with macrovascular complications.

[Cardiovascular risk and type 1 diabetes]. / Risque cardiovasculaire et diabète de type 1.

People with diabetes are considered to have an increased cardiovascular risk. Patients with type 1 diabetes (T1D) generally have a cardiovascular risk profile that is different from those with type 2 diabetes. For this reason, we wanted to assess whether a population of T1D designed to be at very high cardiovascular risk achieved the strict goals recommended by the European Society of Cardiology. This is a descriptive cross-sectional analysis of a cohort of patients with T1D for at least 20 years followed at the University Hospital of Liege and considered to be at very high cardiovascular risk. We then discuss the relevance of strict targets in such patients by comparing them to different scientific societies. Finally, we briefly discuss the potential mechanisms by which T1D present an increased cardiovascular risk.

Les personnes diabétiques sont considérées comme ayant un risque cardiovasculaire accru. Les patients diabétiques de type 1 (DT1) ont un profil de risque cardiovasculaire souvent différent de celui des diabétiques de type 2. Nous avons évalué si une population de patients DT1, dits « à très haut risque cardiovasculaire ¼, atteignait les objectifs stricts recommandés par la Société européenne de cardiologie. Il s'agit d'une analyse transversale descriptive d'une cohorte de patients avec au moins 20 ans de DT1, suivis au CHU de Liège et considérés comme à très haut risque cardiovasculaire. Nous discutons de la pertinence de tels objectifs chez de tels patients, en les comparant à ceux de différentes sociétés savantes. Nous abordons brièvement les mécanismes potentiels à l'origine, dans ce groupe, d'un risque cardiovasculaire accru.

Sustained Impact of Real-time Continuous Glucose Monitoring in Adults With Type 1 Diabetes on Insulin Pump Therapy: Results After the 24-Month RESCUE Study.

OBJECTIVE: In recent years, a growing number of people with type 1 diabetes gained access to real-time continuous glucose monitoring (rtCGM). Long-term benefits of rtCGM are unclear because of a lack of large studies of long duration. We evaluated whether real-world rtCGM use up to 24 months offered benefits, particularly in those living with impaired awareness of hypoglycemia (IAH). RESEARCH DESIGN AND METHODS: This 24-month, prospective, observational cohort study followed 441 adults with insulin pumps receiving full reimbursement for rtCGM. Forty-two percent had IAH. The primary end point was evolution of HbA1c, with secondary end points change in acute hypoglycemia complications, diabetes-related work absenteeism, and quality of life scores. Additionally, we evaluated whether people could achieve glycemic consensus targets during follow-up. RESULTS: After 24 months, HbA1c remained significantly lower compared with baseline (7.64% [60 mmol/mol] vs. 7.37% [57 mmol/mol], P < 0.0001). Sustained benefits were also observed for the score on the hypoglycemia fear survey and hypoglycemia-related acute complications irrespective of hypoglycemia awareness level. People with IAH had the strongest improvement, especially for severe hypoglycemia (862 events in the year before vs. 119 events per 100 patient-years in the 2nd year, P < 0.0001). Over 24 months, more people were able to meet hypoglycemia consensus targets at the expense of slightly fewer people achieving hyperglycemia consensus targets. Furthermore, the number of people with HbA1c <7% (<53 mmol/mol) without severe hypoglycemia events more than doubled (11.0% vs. 25.4%, P < 0.0001). CONCLUSIONS: Use of rtCGM led to sustained improvements in hypoglycemia-related glucose control over 24 months. Lower fear of hypoglycemia, fewer acute hypoglycemia-related events, and fewer diabetes-related days off from work were observed, particularly in those with IAH.

[Artificial pancreas: where are we in 2020†?] / Pancréas artificiel†: où en sommes-nous en 2020†?

The artificial pancreas is a system coupling an automatic insulin infusion according to a continuous glucose monitoring. It is mainly intended for type 1 diabetic patients. Many advances in this area have led to the commercialization of so-called hybrid artificial pancreas devices. These devices always require human intervention to announce the amount of carbohydrates ingested at each meal. The complete fully automated system, called closed loop, is being evaluated thanks to the improvement of prediction algorithms. This paper aims to describe the progress of the artificial pancreas in 2020.

Le pancréas artificiel (PA) est un système couplant la perfusion automatique d'insuline en fonction de la concentration du glucose enregistrée de manière continue. Il s'adresse, principalement, aux patients diabétiques de type 1. Les nombreux progrès en la matière ont permis d'aboutir à la commercialisation de systèmes de PA dits hybrides. Ceux-ci nécessitent toujours une intervention humaine pour l'annonce de la quantité de glucides ingérés aux différents repas. La fermeture complète de la boucle aboutissant à un système autorégulé est en cours d'évaluation grâce à l'amélioration des algorithmes de prédiction. Cet article fait le point sur l'état d'avancement du PA en 2020.