Delphi-Based Consensus on Treatment Intensification in Type 2 Diabetes Subjects Failing Basal Insulin Supported Oral Treatment: Focus on Basal Insulin + GLP-1 Receptor Agonist Combination Therapies

Introduction: The aim of this study was to elaborate a consensus on treatment intensification strategies in patients with type 2 diabetes failing basal insulin supported oral therapy (BOT). The panel focused on glucagon-like peptide-1 receptor agonists (GLP-1RA) and basal insulin (BI) combinations. Methods: The authors developed a Delphi questionnaire organized into ten statements and 77 items that focused on: the definition of BOT and BOT failure, intensification strategies, fixed-dose combinations in general and the BI/GLP-1RA fixed combination. The survey was administered in two rounds to a panel of 80 Italian diabetes specialists, who rated their level of agreement with each item on a 5-point Likert scale. Consensus was predefined as > 66% of the panel agreeing/disagreeing on any given item. Results: Consensus was achieved for 71 of the 77 items. The panel agreed that the use of sulfonylureas in the BOT regimen is inappropriate. BOT failure was defined as individualized targets not being met for glycated hemoglobin, fasting plasma glucose and/or postprandial plasma glucose. There was agreement that postprandial hyperglycaemia and/or presence of nocturnal hypoglycaemia or weight gain define BOT failure. Addition of a GLP-1RA to BI therapy was considered to be the best option for BOT intensification. There was consensus for the use of BI/GLP-1RA fixed combinations as valuable options to increase compliance and safely improve glycaemic control. The panel agreed in considering the fixed-ratio combination insulin degludec/liraglutide (IDegLira) to be preferable to the fixed-ratio combination insulin glargine/lixisenatide (iGlarLixi) in the control of glycaemia, body weight and cardiovascular risk. Conclusion: According to this Delphi consensus, the addition of a GLP-1RA may be the best option to intensify BOT. The BI/GLP-1RA fixed combinations may increase compliance and optimize the advantages of each of these molecules

Patient-reported outcomes in elderly patients with type 2 diabetes mellitus treated with dual oral therapy: a multicenter, observational study from Italy

Objective: To assess patient-reported outcomes after two years of use of dual oral anti-diabetes drug (OAD) therapy in elderly people (≥65 years) with type 2 diabetes mellitus (T2DM) from Italy under real-life settings. Methods: 3-AGE was a prospective, non-interventional study in elderly people with T2DM inadequately controlled on metformin monotherapy (defined as glycated hemoglobin [HbA1c] 7.0–9.0%), in whom a second OAD was prescribed. Primary endpoint was to assess the physical and psychological symptoms associated with T2DM from baseline to 24 months using the Diabetes Symptom Check List revised (DSC-R) questionnaire. Patient’s quality of life and health status, treatment satisfaction, consumption of healthcare resources, and physician satisfaction with treatment were also assessed (secondary endpoints) using validated questionnaires. Additionally, safety and clinical characteristics were also evaluated. Results: The mean age of the study population (N = 860) was 71.5 ± 5.2 years. Addition of a second OAD significantly (p <.0001) reduced the DSC-R score from baseline (0.73 ± 0.68) to both Months 12 and 24 (0.63 ± 0.59 and 0.61 ± 0.56), and HbA1c from baseline (7.72% ± 0.54%) to Month 12 (6.95% ± 0.82%). Adding a second OAD improved quality of life and health status (baseline, 71.31 ± 15.16 to Month 12, 74.49 ± 13.64; p <.0001), patient’s treatment satisfaction (p <.0001), and consumption of healthcare resources per patient. Physicians expressed good satisfaction with patients’ treatment (across efficacy, tolerability and compliance domains) at Month 12. Overall, 32 adverse reactions (in 24 patients) and four hypoglycemic episodes were reported during the 24 months. Conclusion: Addition of a second OAD improved physical and psychological symptoms associated with T2DM and was well tolerated in elderly people under real-life settings

Day service ambulatoriale: una modalità innovativa e tecnologicamente integrata per la gestione di pazienti diabetici complicati

Il progetto, finanziato dal Ministero della Salute, coinvolge 11 Centri Diabetologici Ospedalieri (CDO) lombardi con l'obiettivo di valutare, attraverso uno studio di fattibilit\ue0, come un modello di cura alternativo - il Day Service Ambulatoriale (DSA) - possa contribuire a migliorare la gestione del paziente diabetico, facilitarne l'aderenza terapeutica e la realizzazione di percorsi clinici per la gestione a lungo termine delle complicanze. Si intende, inoltre, verificarne l'impatto sulla qualit\ue0 dell'assistenza sanitaria e sociale, sui costi sanitari e sul miglioramento della qualit\ue0 della vita del paziente. Il DSA \ue8 definito come una modalit\ue0 di assistenza sanitaria innovativa che prevede l'esecuzione di indagini diagnostiche e visite all'interno di uno specifico percorso diagnostico e terapeutico, nel cui ambito lo specialista si fa carico direttamente degli aspetti clinici ed organizzativi della gestione dei pazienti, stabilendo l'itinerario diagnostico e di follow-up in base ad un protocollo condiviso. Obiettivi specifici sono valutare (a) l'efficacia di un 'modello giornaliero di cura' del diabete, in particolare relativamente alla compliance, rispetto al modello di cura ordinario, (b) il rapporto costo/efficacia sulla base di criteri standardizzati, (c) il livello di soddisfazione percepito dai pazienti e dai professionisti sanitari. Questo progetto si propone inoltre di indagare la possibilit\ue0 di inserire un "percorso clinico" per i pazienti diabetici nell'ambito del Sistema Informativo regionale, come un servizio di Electronic Health Record (EHR) cio\ue8 un repository di assistenza sanitaria virtuale, che raccoglie per tutti i cittadini informazioni e documenti clinici prodotti da medici e professionisti sanitari, rendendoli disponibili anche quando sono generati in diverse strutture. In questo ambito \ue8 prevista la creazione di una "cartella virtuale", il cui contenuto viene condiviso tra i diversi attori che collaborano alla gestione del percorso. Lo studio prevede l'arruolamento di 1320 pazienti residenti in Lombardia, di et\ue0 compresa tra 18 e 75 anni, affetti da diabete mellito di tipo 2 con complicanze croniche e/o con controllo glicometabolico insufficiente o affetti da diabete mellito di tipo 1, in base a criteri di convenienza, ovvero agli slot temporali disponibili nei diversi ambulatori. Per i pazienti inseriti nel ramo DSA \ue8 prevista annualmente l'effettuazione di visite di controllo almeno quadrimestrali di cui una in modalit\ue0 DSA. In quest'ultimo caso \ue8 prevista l'erogazione di 'pacchetti di prestazioni', con la possibilit\ue0 per lo specialista diabetologo di scegliere tra un pacchetto base e pacchetti dedicati alle singole complicanze. Tra gli altri pazienti dello stesso ambulatorio, seguiti con modalit\ue0 di cura tradizionale, verr\ue0 selezionato ex-post il gruppo di controllo, con meccanismo casuale. Alla data odierna sono stati predisposti il protocollo e gli strumenti di indagine inclusa la definizione del kit per l'integrazione della cartella clinica virtuale che confluir\ue0 nel Fascicolo Sanitario Elettronico del paziente

Screening of Cushing's syndrome in outpatients with type 2 diabetes: results of a prospective multicentric study in Italy.

Diabete, cortisolo, glicemi

Screening of Cushing's Syndrome in outpatients with type 2 diabetes : results of a prospective multicentric study in Italy

Objective: Our aim was to evaluate the prevalence of unsuspected Cushing\u2019s syndrome among outpatients with type 2 diabetes. Design and Setting: This was a cross-sectional prospective study in 24 diabetes clinics across Italy. Patients: Between June 2006 and April 2008, 813 patients with known type 2 diabetes without clinically overt hypercortisolism were evaluated. Follow-up of the study was closed in September 2010. Patients were not selected for characteristics conferring a higher pretest probability of hypercortisolism. Patients underwent a first screening step with the 1-mg overnight dexamethasone suppression test. Results: Forty patients failed to suppress serum cortisol less than 5.0 g/dl (138 nmol/liter) and underwent a standard 2-d, 2-mg dexamethasone suppression test, after which six patients (0.6% of the overall series) failed to suppress cortisol less than 1.8 g/dl (50 nmol/liter), receiving a definitive diagnosis of Cushing\u2019s syndrome that was adrenal dependent in five patients. Four patients were cured, being able to discontinue, or reduce, the glucose-lowering agents. Conclusions: The present data do not support widespread screening of patients with type 2 diabetes for Cushing\u2019s syndrome; however, the disorder is less rare than previously thought when considering epidemiology of type 2 diabetes. Our results support a case-finding approach in patients with uncontrolled diabetes and hypertension despite appropriate treatment