Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers : clinical results of a multicentric study of 221 consecutive diabetic subjects

OBJECTIVE: To evaluate the feasibility, technical effectiveness and limb salvage potential of percutaneous transluminal angioplasty (PTA), particularly infrapopliteal, in diabetic subjects with ischaemic foot ulcer. DESIGN: Intervention study with PTA in consecutive series. SETTING: Six Diabetology Foot Centres and one Cardiovascular Catheterization Laboratory in Italy. SUBJECTS: Two hundred and twenty-one consecutive diabetic subjects hospitalized for ischaemic foot ulcer. INTERVENTION: Peripheral arterial occlusive disease (PAOD) was investigated by means of foot pulses assessment, ankle-brachial-index (ABI), transcutaneous oxygen tension (TcPO2) and duplex scanning. If non-invasive parameters suggested PAOD, angiography was performed and a PTA was carried out during the same session. MAIN OUTCOME MEASURES: PTA feasibility, improvement of ABI and TcPO2, limb salvage rate, clinical recurrence. RESULTS: On angiography, two patients had stenoses which were 50%, even when longer than 10 cm and/or multiple/calcified. In 11 patients (5.8%) PTA was performed in the proximal axis exclusively, in 81 (42.4%) patients in the infrapopliteal axis exclusively and in 99 (51.8%) in both the femoropopliteal and infrapopliteal axis. Both ABI and TcPO2 improved significantly after PTA (P < 0.0001). Clinical recurrence occurred in 14 subjects: 10 of whom underwent a second successful PTA. Of the 191 patients who underwent PTA, 10 (5.2%) underwent an above-the-ankle amputation. CONCLUSIONS: PTA, including infrapopliteal, is feasible in most diabetic subjects with ischaemic foot ulcer and is effective for foot revascularization. Clinical recurrence was infrequent and the procedure could successfully be repeated in most cases. In subjects treated successfully with PTA the above-the-ankle amputation rate was low. PTA should be considered as the revascularization treatment of first choice in all diabetic subjects with foot ulcer and PAOD

Quality of life and treatment satisfaction in adults with Type 1 diabetes: A comparison between continuous subcutaneous insulin infusion and multiple daily injections

Aims: The aim of this case-control study was to compare quality of life (QoL) and treatment satisfaction in adults with Type 1 diabetes (T1DM) treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Methods: Consecutive patients aged between 18 and 55 years, and attending diabetes clinics for a routine visit, completed the Diabetes-Specific Quality-of-Life Scale (DSQOLS), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the SF-36 Health Survey (SF-36). Case (CSII) and control subjects (MDI) were recruited in a 1 : 2 ratio. Results: Overall, 1341 individuals were enrolled by 62 diabetes clinics; 481 were cases and 860 control subjects. Cases had a longer diabetes duration and were more likely to have eye and renal complications. Age, school education, occupation and HbA1c were similar. Of control subjects, 90% followed glargine-based MDI regimens and 10% used NPH-based MDI regimens. On multivariate analysis, after adjusting for socioeconomic and clinical characteristics, scores in the following areas of the DSQOLS were higher in cases than control subjects: diet restrictions (β = 5.96; P &lt; 0.0001), daily hassles (β = 3.57; P = 0.01) and fears about hypoglycaemia (β = 3.88; P = 0.006). Treatment with CSII was also associated with a markedly higher DTSQ score (β = 4.13; P &lt; 0.0001) compared with MDI. Results were similar when CSII was compared separately with glargine- or NPH-based MDI regimens. Conclusions: This large, non-randomized, case-control study suggests quality of life gains deriving from greater lifestyle flexibility, less fear of hypoglycaemia, and higher treatment satisfaction, when CSII is compared with either glargine-based or NPH-based MDI regimens. © 2008 The Authors

Association of kidney disease measures with risk of renal function worsening in patients with type 1 diabetes

Background: Albuminuria has been classically considered a marker of kidney damage progression in diabetic patients and it is routinely assessed to monitor kidney function. However, the role of a mild GFR reduction on the development of stage 653 CKD has been less explored in type 1 diabetes mellitus (T1DM) patients. Aim of the present study was to evaluate the prognostic role of kidney disease measures, namely albuminuria and reduced GFR, on the development of stage 653 CKD in a large cohort of patients affected by T1DM. Methods: A total of 4284 patients affected by T1DM followed-up at 76 diabetes centers participating to the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD) initiative constitutes the study population. Urinary albumin excretion (ACR) and estimated GFR (eGFR) were retrieved and analyzed. The incidence of stage 653 CKD (eGFR &lt; 60 mL/min/1.73 m2) or eGFR reduction &gt; 30% from baseline was evaluated. Results: The mean estimated GFR was 98 \ub1 17 mL/min/1.73m2 and the proportion of patients with albuminuria was 15.3% (n = 654) at baseline. About 8% (n = 337) of patients developed one of the two renal endpoints during the 4-year follow-up period. Age, albuminuria (micro or macro) and baseline eGFR &lt; 90 ml/min/m2 were independent risk factors for stage 653 CKD and renal function worsening. When compared to patients with eGFR &gt; 90 ml/min/1.73m2 and normoalbuminuria, those with albuminuria at baseline had a 1.69 greater risk of reaching stage 3 CKD, while patients with mild eGFR reduction (i.e. eGFR between 90 and 60 mL/min/1.73 m2) show a 3.81 greater risk that rose to 8.24 for those patients with albuminuria and mild eGFR reduction at baseline. Conclusions: Albuminuria and eGFR reduction represent independent risk factors for incident stage 653 CKD in T1DM patients. The simultaneous occurrence of reduced eGFR and albuminuria have a synergistic effect on renal function worsening

I principi della sostenibilità: dai valori dichiarati al comportamento di consumo alimentare. Analisi del ruolo dei media nella costruzione e diffusione della rappresentazione sociale della sostenibilità

La sostenibilità è un tema ampio che non riguarda solo le politiche istituzionali e le scelte aziendali, ma anche persone qualunque e comportamenti di acquisto e di consumo. Per esempio, il cibo è un tema fortemente connesso alla sostenibilità. Avendo a che fare con la salute e la sensibilità ambientale, la sostenibilità influenza spesso scelte dietetiche, anche se non è ancora chiaro quanto sia forte il condizionamento della sostenibilità sulle persone, se queste siano effettivamente condizionate dal problema, e se il condizionamento provenga da processi diretti e coscienti o da scelte economiche o inconsce. Allo stesso tempo, ciò che emerge è una contraddizione generale tra conoscenze, convinzioni, opinioni, valori professati e comportamenti effettivi: i consumatori agiscono in modo diverso e incoerente rispetto alle loro intenzioni e dichiarazioni. Le loro opinioni e i loro atteggiamenti sono spesso contraddittori, e la coscienza della sostenibilità professata (anche nelle indagini) non corrisponde alle abitudini e comportamenti come consumatori (Biel e Dahlstrand, 2005). Lo scopo di questo lavoro è indagare il rapporto tra sostenibilità e consumo di cibo dal punto di vista dei processi di scelta dei consumatori (De Luca, 2006). Si tenta anche di capire se le scelte dei consumatori siano influenzate dai valori di sostenibilità e se e come questa relazione sia influenzata dalla rappresentazione mediatica della sostenibilità. Per raggiungere tali obiettivi abbiamo condotto diversi tipi di studio: una ricerca qualitativa – interviste con opinion leader e consumatori (giovani e adulti); una ricerca qualitativa con focus group nel Nord e nel Sud Italia; due indagini quantitative condotte nel 2010 e nel 2011 con il coinvolgimento, nel primo caso di circa mille persone di età compresa tra i 18 e i 65 anni e nel secondo di 1.000 giovani di età compresa tra i 18 e i 28 anni; un test sull’impatto della comunicazione sui processi di scelta del consumatore attraverso un esperimento di prefigurazioni di gusto. Il progetto è stato realizzato con il coinvolgimento di gruppi di ricerca dell’Università IULM di Milano, che ha coordinato l’intero progetto, e di gruppi di ricerca delle Università Statali di Milano, Catania e Palermo.Sustainability is a broad subject which concerns not only institutional policies and corporate choices, but also ordinary people purchase and consumption behaviors. For instance, food is an issue strongly connected to sustainability. Concerning health and environmental sensitivity, sustainability often influences diet choices, although it is still not clear how much people are actually conditioned by this issue, and whether such conditioning comes from direct and conscious processes or from profitable or unconscious choices. At the same time, what emerges is a general contradiction between knowledge, beliefs, opinions, professed values and actual behaviors; consumers act differently and inconsistently with respect to their intentions and declarations. Their opinions and attitudes are often contradictory, and the professed sustainability consciousness (in surveys too) doesn’t match with their habits and behaviors as consumers (Biel e Dahlstrand, 2005). The aim of this paper is to investigate the relationship between sustainability and food consumption from the perspective of consumer choice processes (De Luca, 2006). It is also to understand if these consumer choices are influenced by the values of sustainability and whether, and how this relationship is influenced by media representation of the issue of sustainability. To achieve these objectives we conducted several types of study: qualitative research interviews with opinion leaders and consumers (youth and adults); qualitative research with focus groups in northern and southern Italy, two quantitative surveys conducted in 2010 and 2011 with involvement (in the first survey) about one thousand people aged between 18 and 65 years and (in the second survey) of 1.000 young people aged between 18 and 28 years; a survey on the influence of communication on the perception of taste and investigation techniques for implicit confirmation of the data collected using traditional methodology (the questionnaire). The project was implemented with theinvolvement of research teams from the IULM University of Milan, from the State University of Milan, Catania and Palermo

Day service ambulatoriale: una modalit&#224; 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

Predictors of treatment response to liraglutide in type 2 diabetes in a real-world setting

There is an unmet need among healthcare providers to identify subgroups of patients with type 2 diabetes who are most likely to respond to treatment

Effects of medium-long term regular treatment with exenatide in type 2 diabetic patients: A lombard multicenter initiative [Effetti del trattamento persistente con exenatide a medio-lungo termine in soggetti con diabete mellito di tipo 2: Esperienza multicentrica lombarda]

Exenatide (Exe) is a GLP-1 receptor agonist that boosts \u3b2-cell insulin secretion, in order to correct hyperglycemia. Exe also suppresses glucagon release without inhibiting the response to hypoglycemia. This retrospective study examined the efficacy of regular treatment with Exe in type 2 diabetic patients, whose blood glucose was not adequately managed despite lifestyle modifications and oral antidiabetic drugs (OAD). We collected data from 238 outpatients (114 M, 124 F; aged 58.3 \ub1 9.5 years; diabetes duration 10.1 \ub1 6.7 years) from seven diabetes centers in Lombardy (Italy). In order to detect any differences in the effects of Exe in relation to baseline levels of the main metabolic and anthropometric parameters, we divided this population post-hoc on the basis of the medians for the following variables: HbA1c (up to and including 8.5%, or more), fasting plasma glucose (FPG, up to 175 mg/dl, or more), body mass index (BMI, up to 37.5 kg/m2, or more), and diabetes duration (up to 9 years, or more). This gave a good picture of metabolic and anthropometric patterns over time. We also divided patients on the basis of the OAD they were taking at study entry. Metformin was the most widely used non-secretagogue (Group Non-S: 96 patients); sulphonilureas and repaglinide were the main secretagogues (Group S: 142 patients). Group S patients were older than Group Non-S cases (p &lt; 0.01), with a longer diabetes duration, and higher HbA1c and FPG (p &lt; 0.0001). Non-S patients had heavier body weight at baseline (p = 0.001), and higher BMI (p = 0.01). Clinical and anthropometric parameters progressively and uniformly declined, most markedly HbA1c, which was higher at baseline in Group S. Exe reduced body weight more in the Non-S group, reaching statistical significance after 24 months (p = 0.01). These findings confirm the therapeutic efficacy of Exe for better glycemic control and body weight reduction after a medium-long period of treatment. Previous use of oral secretagogues did not invalidate the fa-vorable effect of Exe on some of the main cardiovascular risk factors

Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial

OBJECTIVE We aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODSdThe 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9-7.8%]) at 39 diabetes clinics in Italy. After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months. Two primary end points were tested in hierarchical order: HbA1c change at 12 months and percentage of patients at risk target for low and high blood glucose index. RESULTSdIntent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (20.39%) than in AC patients (20.27%), with a between-group difference of 20.12% (95% CI, 20.210 to 20.024; P = 0.013). In the per-protocol analysis, the between-group difference was 20.21% (20.331 to 20.089; P = 0.0007). More ISM than AC patients achieved clinically meaningful reductions in HbA1c (>0.3, >0.4, or >0.5%) at study end (P< 0.025). The proportion of patients reaching/maintaining the risk target at month 12 was similar in ISM (74.6%) and AC (70.1%) patients (P = 0.131). At visits 2, 3, and 4, diabetes medications were changed more often in ISM than in AC patients (P <0.001). CONCLUSIONSdUse of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulintreated type 2 diabetes. © 2013 by the American Diabetes Association