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1. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case-Control Study.

Author

Lepore G, Scaranna C, Corsi A, Dodesini AR, and Trevisan R

Subjects
Adult, Blood Glucose analysis, Blood Glucose Self-Monitoring, Case-Control Studies, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 complications, Female, Humans, Hypoglycemia etiology, Hypoglycemia prevention & control, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Diabetes Mellitus, Type 1 drug therapy, Glycemic Control instrumentation, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems
Abstract

There are no data whether hybrid closed-loop (HCL) systems are superior to sensor-augmented pump (SAP) therapy with predictive low glucose suspend (PLGS) feature in improving glucose control. Aim of our study was to evaluate the effect on metabolic control and glucose variability of the switch from SAP therapy with PLGS to a HCL system in type 1 diabetic individuals. Forty adults with type 1 diabetes, who had been using SAP therapy with PLGS feature (Minimed 640G; Medtronic, Northridge, CA) for at least 12 months were evaluated in a 6-month case-control observational retrospective study. Twenty subjects who consecutively switched from Minimed 640G to a HCL system (Minimed 670G; Medtronic) (670G group) were compared with a control group consisting of 20 subjects who continued with the MiniMed 640G pump (640G group) matched for age, gender, and HbA 1c . At the end of the study there was a significant reduction in average HbA 1c levels (-4.9 ± 6.4 mmol/mol [-0.4% ± 0.6%], P  < 0.01), sensor glucose concentrations (-15.4 ± 17.7 mg/dL, P  < 0.005), coefficient of variation of sensor glucose concentrations (-3.8% ± 3.6%, P  < 0.01), percentage time spent in both hyperglycemic range 181-250 mg/dL (-5.1% ± 4.5%, P  < 0.05), and >250 mg/dL (-6.1% ± 6.9%, P  < 0.05) in the 670G group, whereas they remained unchanged in the 640G group. Percentage of time spent in euglycemic range significantly increased (11.6% ± 8.3%, P  < 0.005) only in the 670G group. There was no change in time spent in hypoglycemic range in both groups. In adults with type 1 diabetes, switching from a 640G to a 670G system significantly improved glucose control and reduced glucose variability, thus reaching in most cases the recommended targets for time spent in euglycemic and hyperglycemic ranges without increasing the risk of hypoglycemia.

Published
2020
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2. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial.

Author

Vaccaro O, Masulli M, Nicolucci A, Bonora E, Del Prato S, Maggioni AP, Rivellese AA, Squatrito S, Giorda CB, Sesti G, Mocarelli P, Lucisano G, Sacco M, Signorini S, Cappellini F, Perriello G, Babini AC, Lapolla A, Gregori G, Giordano C, Corsi L, Buzzetti R, Clemente G, Di Cianni G, Iannarelli R, Cordera R, La Macchia O, Zamboni C, Scaranna C, Boemi M, Iovine C, Lauro D, Leotta S, Dall'Aglio E, Cannarsa E, Tonutti L, Pugliese G, Bossi AC, Anichini R, Dotta F, Di Benedetto A, Citro G, Antenucci D, Ricci L, Giorgino F, Santini C, Gnasso A, De Cosmo S, Zavaroni D, Vedovato M, Consoli A, Calabrese M, di Bartolo P, Fornengo P, and Riccardi G

Subjects
Aged, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Diabetes Mellitus, Type 2 epidemiology, Drug Therapy, Combination, Female, Humans, Incidence, Male, Middle Aged, Pioglitazone, Treatment Outcome, Cardiovascular Diseases drug therapy, Diabetes Mellitus, Type 2 complications, Hypoglycemic Agents therapeutic use, Metformin therapeutic use, Sulfonylurea Compounds therapeutic use, Thiazolidinediones therapeutic use
Abstract

Background: The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes., Methods: TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50-75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2-3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15-45 mg) or a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856., Findings: Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74-1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p<0·0001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups., Interpretation: In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events., Funding: Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Published
2017
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3. Bolus calculator improves long-term metabolic control and reduces glucose variability in pump-treated patients with Type 1 diabetes.

Author

Lepore G, Dodesini AR, Nosari I, Scaranna C, Corsi A, and Trevisan R

Subjects
Adult, Automation, Biomarkers blood, Blood Glucose metabolism, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 diagnosis, Equipment Design, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemia chemically induced, Hypoglycemia prevention & control, Hypoglycemic Agents adverse effects, Infusions, Subcutaneous, Insulin adverse effects, Male, Middle Aged, Software Design, Time Factors, Treatment Outcome, Blood Glucose drug effects, Blood Glucose Self-Monitoring instrumentation, Diabetes Mellitus, Type 1 drug therapy, Drug Dosage Calculations, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems
Published
2012
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4. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

5. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Giuseppe Lepore, Riccardo Bonfanti, Lutgarda Bozzetto, Vincenzo Di Blasi, Angela Girelli, Giorgio Grassi, Dario Iafusco, Luigi Laviola, Ivana Rabbone, Riccardo Schiaffini, Daniela Bruttomesso, F. Mammì, M. Bruzzese, M. Schettino, M.G. Nuzzo, V. Di Blasi, R. Fresa, C. Lambiase, D. Iafusco, A. Zanfardino, S. Confetto, L. Bozzetto, G. Annuzzi, A. Alderisio, G. Riccardi, S. Gentile, G. Marino, G. Guarino, S. Zucchini, G. Maltoni, T. Suprani, V. Graziani, M. Nizzoli, S. Acquati, R. Cavani, S. Romano, M. Michelini, E. Manicardi, R. Bonadonna, A. Dei Cas, E. Dall'aglio, M. Papi, S. Riboni, V. Manicardi, V. Pugni, A. Lasagni, M.E. Street, U. Pagliani, C. Rossi, R. Assaloni, B. Brunato, C. Tortul, G. Zanette, P. Li Volsi, M. Zanatta, L. Tonutti, S. Agus, M.A. Pellegrini, P. Ceccano, G. Pozzilli, Beretta Anguissola, R. Buzzetti, C. Moretti C, G. Leto, P. Pozzilli, S. Manfrini, A.R. Maurizi, S. Leotta, M. Altomare, S. Abbruzzese, S. Carletti, C. Suraci, S. Filetti, M.L. Manca Bitti, S. Arcano, M.G. Cavallo, M. De Bernardinis, D. Pitocco, S. Caputo, A. Rizzi, A. Manto, R. Schiaffini, M. Cappa, D. Benevento, S. Frontoni, I. Malandrucco, S. Morano, T. Filardi, D. Lauro, M.A. Marini, E. Castaldo, D. Sabato, F. Tuccinardi, E. Forte, P. Viterbori, C. Arnaldi, N. Minuto, G. d'Annunzio, A. Corsi, R. Rota, C. Scaranna, R. Trevisan, U. Valentini, A. Girelli, S. Bonfadini, E. Zarra, A. Plebani, E. Prandi, B. Felappi, A. Rocca, E. Meneghini, P. Galli, P. Ruggeri, E. Carrai, L. Fugazza, V. Baggi, D. Conti, E. Bosi, A. Laurenzi, A. Caretto, C. Molinari, E. Orsi, V. Grancini, V. Resi, R. Bonfanti, V. Favalli, C. Bonura, A. Rigamonti, M. Bonomo, F. Bertuzzi, B. Pintaudi, O. Disoteo, G. Perseghin, S. Perra, L. Chiovato, P. De Cata, F. Zerbini, E. Lovati, M. Laneri, L. Guerraggio, A.C. Bossi, V. De Mori, M. Galetta, I. Meloncelli, A. Aiello A, S. Di Vincenzo, A. Nuzzi, E. Fraticelli, E. Ansaldi, M. Battezzati, M. Lombardi, M. Balbo, R. Lera, A. Secco, V. De Donno, F. Cadario, S. Savastio, C. Ponzani, G. Aimaretti, I. Rabbone, G. Ignaccolo, D. Tinti, F. Cerutti, F. Bari, F. Giorgino, E. Piccinno, O. Zecchino, M. Cignarelli, O. Lamacchia, G. Picca, S. De Cosmo, A. Rauseo, L. Tomaselli, A. Tumminia, C. Egiziano, A.M. Scarpitta, F. Maggio, F. Cardella, R. Roppolo, V. Provenzano, M. Fleres, A. Scorsone, A. Scatena, G. Gregori, S. Lucchesi, F. Gadducci, S. Di Cianni, S. Pancani, S. Del Prato, M. Aragona, I. Crisci, A. Calianno, B. Fattor, D. Crazzolara, P. Reinstadler, S. Longhi, G. Incelli, S. Rauch, T. Romanelli, M. Orrasch, V. Cauvin, R. Franceschi, C. Lalli, A. Pianta, A. Marangoni, C.N. Aricò, N. Marin, N. Nogara, N. Simioni, A. Filippi, G.L. Gidoni Guarneri, M.L. Contin M.L, A.P. Decata, L. Bondesan, L. Confortin, A. Coracina, S. Lombardi, S. Costa Padova, E. Cipponeri, R. Scotton, S. Galasso, F. Boscari, M.S. Zanon, C. Vinci, G. Lisato, L. Gottardo, E. Bonora, M. Trombetta, C. Negri, C. Brangani, C. Maffeis, A. Sabbion, M. Marigliano, Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Laviola, Luigi, Rabbone, Ivana, Schiaffini, Riccardo, Bruttomesso, Daniela, Lepore, G., Bonfanti, R., Bozzetto, L., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Laviola, L., Rabbone, I., Schiaffini, R., Bruttomesso, D., Mammi, F., Bruzzese, M., Schettino, M., Nuzzo, M. G., Fresa, R., Lambiase, C., Zanfardino, A., Confetto, S., Annuzzi, G., Alderisio, A., Riccardi, G., Gentile, S., Marino, G., Guarino, G., Zucchini, S., Maltoni, G., Suprani, T., Graziani, V., Nizzoli, M., Acquati, S., Cavani, R., Romano, S., Michelini, M., Manicardi, E., Bonadonna, R., Dei Cas, A., Dall'Aglio, E., Papi, M., Riboni, S., Manicardi, V., Pugni, V., Lasagni, A., Street, M. E., Pagliani, U., Rossi, C., Assaloni, R., Brunato, B., Tortul, C., Zanette, G., Li Volsi, P., Zanatta, M., Tonutti, L., Agus, S., Pellegrini, M. A., Ceccano, P., Pozzilli, G., Anguissola, B., Buzzetti, R., Moretti C, C., Leto, G., Pozzilli, P., Manfrini, S., Maurizi, A. R., Leotta, S., Altomare, M., Abbruzzese, S., Carletti, S., Suraci, C., Filetti, S., Manca Bitti, M. L., Arcano, S., Cavallo, M. G., De Bernardinis, M., Pitocco, D., Caputo, S., Rizzi, A., Manto, A., Cappa, M., Benevento, D., Frontoni, S., Malandrucco, I., Morano, S., Filardi, T., Lauro, D., Marini, M. A., Castaldo, E., Sabato, D., Tuccinardi, F., Forte, E., Viterbori, P., Arnaldi, C., Minuto, N., D'Annunzio, G., Corsi, A., Rota, R., Scaranna, C., Trevisan, R., Valentini, U., Bonfadini, S., Zarra, E., Plebani, A., Prandi, E., Felappi, B., Rocca, A., Meneghini, E., Galli, P., Ruggeri, P., Carrai, E., Fugazza, L., Baggi, V., Conti, D., Bosi, E., Laurenzi, A., Caretto, A., Molinari, C., Orsi, E., Grancini, V., Resi, V., Favalli, V., Bonura, C., Rigamonti, A., Bonomo, M., Bertuzzi, F., Pintaudi, B., Disoteo, O., Perseghin, G., Perra, S., Chiovato, L., De Cata, P., Zerbini, F., Lovati, E., Laneri, M., Guerraggio, L., Bossi, A. C., De Mori, V., Galetta, M., Meloncelli, I., Aiello A, A., Di Vincenzo, S., Nuzzi, A., Fraticelli, E., Ansaldi, E., Battezzati, M., Lombardi, M., Balbo, M., Lera, R., Secco, A., De Donno, V., Cadario, F., Savastio, S., Ponzani, C., Aimaretti, G., Ignaccolo, G., Tinti, D., Cerutti, F., Bari, F., Giorgino, F., Piccinno, E., Zecchino, O., Cignarelli, M., Lamacchia, O., Picca, G., De Cosmo, S., Rauseo, A., Tomaselli, L., Tumminia, A., Egiziano, C., Scarpitta, A. M., Maggio, F., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Scorsone, A., Scatena, A., Gregori, G., Lucchesi, S., Gadducci, F., Di Cianni, S., Pancani, S., Del Prato, S., Aragona, M., Crisci, I., Calianno, A., Fattor, B., Crazzolara, D., Reinstadler, P., Longhi, S., Incelli, G., Rauch, S., Romanelli, T., Orrasch, M., Cauvin, V., Franceschi, R., Lalli, C., Pianta, A., Marangoni, A., Arico, C. N., Marin, N., Nogara, N., Simioni, N., Filippi, A., Gidoni Guarneri, G. L., Contin, M. L M. L., Decata, A. P., Bondesan, L., Confortin, L., Coracina, A., Lombardi, S., Costa Padova, S., Cipponeri, E., Scotton, R., Galasso, S., Boscari, F., Zanon, M. S., Vinci, C., Lisato, G., Gottardo, L., Bonora, E., Trombetta, M., Negri, C., Brangani, C., Maffeis, C., Sabbion, A., Marigliano, M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, and Marigliano, M

Subjects
Blood Glucose, Male, Pediatrics, Acute and chronic complication, Glycated Hemoglobin A, Time Factors, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Medicine (miscellaneous), Ketosi, Infusions, Subcutaneous, Settore MED/13 - Endocrinologia, Acute and chronic complications, Continuous subcutaneous insulin infusion (CSII), Diabetes mellitus, Metabolic control, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, 0302 clinical medicine, Endocrinology, Adolescent, Adult, Albuminuria, Biomarkers, Child, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy, Female, Health Care Surveys, Humans, Hypertension, Hypoglycemia, Hypoglycemic Agents, Insulin, Italy, Ketosis, Middle Aged, Risk Factors, Treatment Outcome, Young Adult, Insulin Infusion Systems, 030212 general & internal medicine, Subcutaneous, Diabetic retinopathy, Diabetes and Metabolism, medicine.symptom, Type 2, Human, Type 1, Insulin pump, Infusions, medicine.medical_specialty, Diabetes mellitu, Time Factor, 030209 endocrinology & metabolism, 03 medical and health sciences, medicine, Cross-Sectional Studie, Glycated Hemoglobin, Type 1 diabetes, Hypoglycemic Agent, business.industry, Risk Factor, Biomarker, medicine.disease, Ketoacidosis, Infusions, Subcutaneou, Health Care Survey, Diabetic Nephropathie, business
Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. 18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

6. Switching to the Minimed™ 780G system achieves clinical targets for CGM in adults with type 1 diabetes regardless of previous insulin strategy and baseline glucose control

Author

Giuseppe Lepore, Alessandro Rossini, Rosalia Bellante, Anna Corsi, Cristiana Scaranna, Alessandro Roberto Dodesini, Roberto Trevisan, Lepore, G, Rossini, A, Bellante, R, Corsi, A, Scaranna, C, Dodesini, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, Advanced hybrid closed-loop system, Glucose sensor, Continuous subcutaneous insulin infusion, Blood Glucose Self-Monitoring, Endocrinology, Diabetes and Metabolism, General Medicine, Middle Aged, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Endocrinology, Internal Medicine, Insulin therapy, Humans, Hypoglycemic Agents, Insulin, Female, Insulin pump, Type 1 diabetes mellitu, Retrospective Studies
Abstract

Aims: Advanced hybrid closed-loop (AHCL) systems represent the latest introduction in the treatment of type 1 diabetes (T1DM). Randomized controlled trials and real-world evidence studies showed that AHCL systems are a safe and effective insulin management strategy. Aim of this retrospective, single-center, real-life study was to evaluate the effect on metabolic control, evaluated by continuous glucose monitoring (CGM) metrics, of the switch from four available insulin strategies to an AHCL system in adult patients with type 1 diabetes. Methods: A total of 102 patients with T1DM (mean age 42.1 ± 16.3 years, males/females 47/55, duration of diabetes 21.4 ± 13.3 years, BMI 24.4 ± 4.5 kg/m2, HbA1c 59.9 ± 9.6 mmol/mol or 7.6 ± 0.9%), treated with four different insulin therapies [multiple daily insulin (MDI) therapy, continuous subcutaneous insulin infusion (CSII), sensor-augmented pump (SAP) with predictive low-glucose suspend (PLGS), and hybrid closed loop (HCL) system] were evaluated before hand, two months and six months after switching to an AHCL (Minimed™ 780G system, Medtronic, Northridge, CA) system. Results: Two months after the switch, mean GCM metrics improved in all four treatment groups. Six months after the switch, the participants of all four groups achieved a mean GMI < 53 mmol/mol, TIR > 70%, TBR < 4%, and CV < 36%, which is recommended by the ADA Standard of Medical Care in Diabetes 2022, including the MDI group with worse baseline glycemic control. Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to six months independently of previous insulin treatment and baseline conditions.

Published
2022
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7. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case–Control Study

Author

Giuseppe Lepore, Anna Maria Corsi, Alessandro Roberto Dodesini, Roberto Trevisan, Cristiana Scaranna, Lepore, G, Scaranna, C, Corsi, A, Dodesini, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Glucose control, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Glycemic Control, Low insulin, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, Hybrid closed-loop system, Predictive low glucose suspend, Sensor-augmented pump, Type 1 diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Low glucose suspend, Retrospective Studies, business.industry, Blood Glucose Self-Monitoring, Case-control study, Middle Aged, medicine.disease, Hypoglycemia, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Treatment Outcome, Feature (computer vision), Case-Control Studies, Cardiology, Female, Observational study, business, Closed loop
Abstract

There are no data whether hybrid closed-loop (HCL) systems are superior to sensor-augmented pump (SAP) therapy with predictive low glucose suspend (PLGS) feature in improving glucose control. Aim of our study was to evaluate the effect on metabolic control and glucose variability of the switch from SAP therapy with PLGS to a HCL system in type 1 diabetic individuals. Forty adults with type 1 diabetes, who had been using SAP therapy with PLGS feature (Minimed 640G; Medtronic, Northridge, CA) for at least 12 months were evaluated in a 6-month case-control observational retrospective study. Twenty subjects who consecutively switched from Minimed 640G to a HCL system (Minimed 670G; Medtronic) (670G group) were compared with a control group consisting of 20 subjects who continued with the MiniMed 640G pump (640G group) matched for age, gender, and HbA1c. At the end of the study there was a significant reduction in average HbA1c levels (-4.9 ± 6.4 mmol/mol [-0.4% ± 0.6%], P < 0.01), sensor glucose concentrations (-15.4 ± 17.7 mg/dL, P < 0.005), coefficient of variation of sensor glucose concentrations (-3.8% ± 3.6%, P < 0.01), percentage time spent in both hyperglycemic range 181-250 mg/dL (-5.1% ± 4.5%, P < 0.05), and >250 mg/dL (-6.1% ± 6.9%, P < 0.05) in the 670G group, whereas they remained unchanged in the 640G group. Percentage of time spent in euglycemic range significantly increased (11.6% ± 8.3%, P < 0.005) only in the 670G group. There was no change in time spent in hypoglycemic range in both groups. In adults with type 1 diabetes, switching from a 640G to a 670G system significantly improved glucose control and reduced glucose variability, thus reaching in most cases the recommended targets for time spent in euglycemic and hyperglycemic ranges without increasing the risk of hypoglycemia.

Published
2020
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8. Continuous subcutaneous insulin infusion reduces maternal and neonatal risk in pregnant women with type 1 diabetes: An observational cohort study of 122 pregnancies

Author

Silvia Galliani, Giorgia Cavalli, Cristiana Scaranna, Anna Maria Corsi, Giuseppe Lepore, Mascia Albizzi, Rosalia Bellante, G. Mangili, Alessandro Roberto Dodesini, Elena Ciriello, Roberto Trevisan, Dodesini, A, Cavalli, G, Ciriello, E, Lepore, G, Corsi, A, Scaranna, C, Bellante, R, Albizzi, M, Galliani, S, Mangili, G, and Trevisan, R

Subjects
Adult, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Infusions, Subcutaneous, Injections, Cohort Studies, Insulin Infusion Systems, Pregnancy, Diabetes mellitus, continuous subcutaneous insulin infusion, large for gestational age, multiple daily injections, pregnancy, type 1 diabetes, medicine, Humans, Hypoglycemic Agents, Insulin, Aged, Type 1 diabetes, business.industry, Obstetrics, Infant, Newborn, medicine.disease, Subcutaneous insulin, Diabetes Mellitus, Type 1, Treatment Outcome, Female, business, Cohort study
Published
2020
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9. Bolus calculator improves long-term metabolic control and reduces glucose variability in pump-treated patients with Type 1 diabetes

Author

C. Scaranna, I. Nosari, Giuseppe Lepore, R. Trevisan, Anna Maria Corsi, Alessandro Roberto Dodesini, Lepore, G, Dodesini, A, Nosari, I, Scaranna, C, Corsi, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), Infusions, Subcutaneous, Automation, Bolus (medicine), Insulin Infusion Systems, Software Design, Internal medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Drug Dosage Calculations, Glycated Hemoglobin, Type 1 diabetes, Nutrition and Dietetics, business.industry, Blood Glucose Self-Monitoring, Equipment Design, type 1 diabetes, glucose variability, bolus calculator, Middle Aged, medicine.disease, Hypoglycemia, Diabetes Mellitus, Type 1, Treatment Outcome, Metabolic control analysis, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Biomarkers
Published
2012

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