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3. A sub-analysis of the SAGE study in Italy indicates good glycemic control in type 1 diabetes

Author

Anichini, Roberto, Magiar, Alice, Maria Baggiore, Cristiana, Disoteo, Olga, Porcu, Antonella, Bonora, Enzo, Trombetta, Maddalena, Bruttomesso, Daniela, Boscari, Federico, Carrano, Mario, Gisella Cavallo, Maria, Giorgio Baroni, Marco, Di Carlo, Alberto, Casadidio, Ilaria, Di Mauro, Maurizio, Foglia, Angelo, De Simone, Anna, Frittitta, Lucia, Garrapa, Gabriella, Giorda, Bruno, Nada Chieri, Elisa, Guarino, Giuseppina, Gentile, Sandro, Irace, Concetta, Catalano, Serena, Lauro, Davide, Maggi, Davide, Ambrosett, Eleonora, Maranghi, Marianna, Pergolini, Daniela, Letizia Petroni, Maria, Marchignoli, Francesca, Orsi, Emanuela, Gaglio, Alessia, Piatti, Piermarco, Monti, Lucilla, Pozzilli, Paolo, Pieralice, Silvia, Privitera, Filippo, Trevisan, Roberto, Albizzi, Mascia, Buzzetti, Raffaella, Carlone, Angela, Pitocco, Dario, Tartaglione, Linda, Bruttomesso, D., Irace, C., and Pozzilli, P.

Published
2023
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10. Newly-diagnosed diabetes and admission hyperglycemia predict COVID-19 severity by aggravating respiratory deterioration

Author

Fadini, Gian Paolo, Morieri, Mario Luca, Boscari, Federico, Fioretto, Paola, Maran, Alberto, Busetto, Luca, Bonora, Benedetta Maria, Selmin, Elisa, Arcidiacono, Gaetano, Pinelli, Silvia, Farnia, Filippo, Falaguasta, Daniele, Russo, Lucia, Voltan, Giacomo, Mazzocut, Sara, Costantini, Giorgia, Ghirardini, Francesca, Tresso, Silvia, Cattelan, Anna Maria, Vianello, Andrea, Avogaro, Angelo, and Vettor, Roberto

Published
2020
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14. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial

Author

Kropff, Jort, Del Favero, Simone, Place, Jerome, Toffanin, Chiara, Visentin, Roberto, Monaro, Marco, Messori, Mirko, Di Palma, Federico, Lanzola, Giordano, Farret, Anne, Boscari, Federico, Galasso, Silvia, Magni, Paolo, Avogaro, Angelo, Keith-Hynes, Patrick, Kovatchev, Boris P, Bruttomesso, Daniela, Cobelli, Claudio, DeVries, J Hans, Renard, Eric, and Magni, Lalo

Published
2015
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16. A sub-analysis of the SAGE study in Italy indicates good glycemic control in type 1 diabetes

Author

Bruttomesso, D., primary, Irace, C., additional, Pozzilli, P., additional, Anichini, Roberto, additional, Magiar, Alice, additional, Maria Baggiore, Cristiana, additional, Disoteo, Olga, additional, Porcu, Antonella, additional, Bonora, Enzo, additional, Trombetta, Maddalena, additional, Bruttomesso, Daniela, additional, Boscari, Federico, additional, Carrano, Mario, additional, Gisella Cavallo, Maria, additional, Giorgio Baroni, Marco, additional, Di Carlo, Alberto, additional, Casadidio, Ilaria, additional, Di Mauro, Maurizio, additional, Foglia, Angelo, additional, De Simone, Anna, additional, Frittitta, Lucia, additional, Garrapa, Gabriella, additional, Giorda, Bruno, additional, Nada Chieri, Elisa, additional, Guarino, Giuseppina, additional, Gentile, Sandro, additional, Irace, Concetta, additional, Catalano, Serena, additional, Lauro, Davide, additional, Maggi, Davide, additional, Ambrosett, Eleonora, additional, Maranghi, Marianna, additional, Pergolini, Daniela, additional, Letizia Petroni, Maria, additional, Marchignoli, Francesca, additional, Orsi, Emanuela, additional, Gaglio, Alessia, additional, Piatti, Piermarco, additional, Monti, Lucilla, additional, Pozzilli, Paolo, additional, Pieralice, Silvia, additional, Privitera, Filippo, additional, Trevisan, Roberto, additional, Albizzi, Mascia, additional, Buzzetti, Raffaella, additional, Carlone, Angela, additional, Pitocco, Dario, additional, and Tartaglione, Linda, additional

Published
2022
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17. Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes

Author

Brown, Sue A, Breton, Marc D, Anderson, Stacey M, Kollar, Laura, Keith-Hynes, Patrick, Levy, Carol J, Lam, David W, Levister, Camilla, Baysal, Nihat, Kudva, Yogish C, Basu, Ananda, Dadlani, Vikash, Hinshaw, Ling, McCrady-Spitzer, Shelly, Bruttomesso, Daniela, Visentin, Roberto, Galasso, Silvia, del Favero, Simone, Leal, Yenny, Boscari, Federico, Avogaro, Angelo, Cobelli, Claudio, and Kovatchev, Boris P

Published
2017

19. Performance of intermittently scanned continuous glucose monitoring systems in people with type 1 diabetes: A pooled analysis

Author

Moser, Othmar, primary, Sternad, Christoph, additional, Eckstein, Max L., additional, Szadkowska, Agnieszka, additional, Michalak, Arkadiusz, additional, Mader, Julia K., additional, Ziko, Haris, additional, Elsayed, Hesham, additional, Aberer, Felix, additional, Sola‐Gazagnes, Agnes, additional, Larger, Etienne, additional, Fadini, Gian Poalo, additional, Bonora, Benedetta Maria, additional, Bruttomesso, Daniela, additional, Boscari, Federico, additional, Freckmann, Guido, additional, Pleus, Stefan, additional, Christiansen, Sverre C., additional, and Sourij, Harald, additional

Published
2021
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23. sj-pdf-1-dst-10.1177_19322968211043162 – Supplemental material for Methods for Insulin Bolus Adjustment Based on the Continuous Glucose Monitoring Trend Arrows in Type 1 Diabetes: Performance and Safety Assessment in an In Silico Clinical Trial

Author

Noaro, Giulia, Cappon, Giacomo, Sparacino, Giovanni, Boscari, Federico, Bruttomesso, Daniela, and Facchinetti, Andrea

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-pdf-1-dst-10.1177_19322968211043162 for Methods for Insulin Bolus Adjustment Based on the Continuous Glucose Monitoring Trend Arrows in Type 1 Diabetes: Performance and Safety Assessment in an In Silico Clinical Trial by Giulia Noaro, Giacomo Cappon, Giovanni Sparacino, Federico Boscari, Daniela Bruttomesso and Andrea Facchinetti in Journal of Diabetes Science and Technology

Published
2021
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24. Hyperglycemia, glucocorticoid therapy, and outcome of COVID-19

Author

Morieri, Mario Luca, Fadini, Gian Paolo, Boscari, Federico, Fioretto, Paola, Maran, Alberto, Busetto, Luca, Crepaldi, Maria Cristina, Vedovato, Monica, Bonora, Benedetta Maria, Selmin, Elisa, Arcidiacono, Gaetano, Pinelli, Silvia, Farnia, Filippo, Falaguasta, Daniele, Russo, Lucia, Voltan, Giacomo, Mazzocut, Sara, Costantini, Giorgia, Ghirardini, Francesca, Tresso, Silvia, Cattelan, Anna Maria, Vianello, Andrea, Vettor, Roberto, and Avogaro, Angelo

Published
2020
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25. Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas

Author

Kovatchev, Boris P., Renard, Eric, Cobelli, Claudio, Zisser, Howard C., Keith-Hynes, Patrick, Anderson, Stacey M., Brown, Sue A., Chernavvsky, Daniel R., Breton, Marc D., Mize, Lloyd B., Farret, Anne, Place, Jérôme, Bruttomesso, Daniela, Del Favero, Simone, Boscari, Federico, Galasso, Silvia, Avogaro, Angelo, Magni, Lalo, Di Palma, Federico, Toffanin, Chiara, Messori, Mirko, Dassau, Eyal, and Doyle, Francis J., III

Published
2014
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28. Performance of intermittently scanned continuous glucose monitoring systems in people with type 1 diabetes: A pooled analysis.

Author

Moser, Othmar, Sternad, Christoph, Eckstein, Max L., Szadkowska, Agnieszka, Michalak, Arkadiusz, Mader, Julia K., Ziko, Haris, Elsayed, Hesham, Aberer, Felix, Sola‐Gazagnes, Agnes, Larger, Etienne, Fadini, Gian Poalo, Bonora, Benedetta Maria, Bruttomesso, Daniela, Boscari, Federico, Freckmann, Guido, Pleus, Stefan, Christiansen, Sverre C., and Sourij, Harald

Subjects
TYPE 1 diabetes, BLOOD sugar, BLOOD sugar measurement, BLAND-Altman plot
Abstract

Aims: To conduct a pooled analysis to assess the performance of intermittently scanned continuous glucose monitoring (isCGM) in association with the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes. Material and Methods: In this pooled analysis, isCGM system accuracy was assessed depending on the rate of change in sensor glucose. Clinical studies that have been investigating isCGM accuracy against blood glucose, accompanied with collection time points were included in this analysis. isCGM performance was assessed by means of median absolute relative difference (MedARD), Parkes error grid (PEG) and Bland‐Altman plot analyses. Results: Twelve studies comprising 311 participants were included, with a total of 15 837 paired measurements. The overall MedARD (interquartile range) was 12.7% (5.9‐23.5) and MedARD differed significantly based on the rate of change in glucose (P < 0.001). An absolute difference of −22 mg/dL (−1.2 mmol/L) (95% limits of agreement [LoA] 60 mg/dL (3.3 mmol/L), −103 mg/dL (−5.7 mmol/L)) was found when glucose was rapidly increasing (isCGM glucose minus reference blood glucose), while a −32 mg/dL (1.8 mmol/L) (95% LoA 116 mg/dL (6.4 mmol/L), −51 mg/dL (−2.8 mmol/L)) absolute difference was observed in periods of rapidly decreasing glucose. Conclusions: The performance of isCGM was good when compared to reference blood glucose measurements. The rate of change in glucose for both increasing and decreasing glucose levels diminished isCGM performance, showing lower accuracy during high rates of glucose change. [ABSTRACT FROM AUTHOR]

Published
2022
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31. Performance of the Steno type 1 risk engine for cardiovascular disease prediction in Italian patients with type 1 diabetes

Author

Boscari, Federico, primary, Morieri, Mario Luca, additional, Amato, Anna Maria Letizia, additional, Vallone, Valeria, additional, Uliana, Ambra, additional, Baritussio, Anna, additional, Vitturi, Nicola, additional, Cipponeri, Elisa, additional, Cavallin, Francesco, additional, Avogaro, Angelo, additional, Fadini, Gian Paolo, additional, and Bruttomesso, Daniela, additional

Published
2020
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32. Artificial pancreas development in type 1 diabetic patients

Author

Boscari, Federico

Subjects
Artificial pancreas/Pancreas Artificiale type 1 diabetes/ Diabete mellito tipo 1, MED/13 Endocrinologia, Settore MED/13 - Endocrinologia
Abstract

Introduction and background: In type 1 diabetic patients good glycaemic control is associated with complication reduction. Nevertheless a minority of patients, also treated with insulin pumps and continuous glucose monitoring (SAP therapy) achieve a satisfactory metabolic control. Several researchers are developing automatic systems, called artificial pancreas (AP) or Closed Loop Control (CLC). This system are composed by an insulin pump, a continuous glucose monitoring device and a control algorithm which modifies insulin infusion from data derived by continuous glucose monitoring. Several AP models exist, composed by different insulin pumps, different continuous glucose monitoring system and by different control algorithms that determine the precision of glucose control. Method: we evaluated our AP model efficacy and safety at patients home compared to SAP therapy. In our AP model, the Algorithm is installed in a smartphone (DiAS, Diabetes Assistant) that communicate with pump and CGM thought blue tooth connection. We developed 5 studies that tested the system in free life condition, first during evening and night, than for 24 hours and for longer period (6 months). We finally evaluated this system in pediatric population. Results: In a randomized cross over study of 2 month AP use during evening and night vs SAP therapy, system usage improved time in target (70-180 mg/dl) from 58.1% to 66.7% ( P < 0.0001), reduce mean glucose concentration (162 mg/dl vs 167 mg/dl, P=0.0053) and time spent in hypoglycemia (

Published
2018

33. The International Diabetes Closed-Loop Study: Testing Artificial Pancreas Component Interoperability

Author

Anderson, Stacey M., primary, Dassau, Eyal, additional, Raghinaru, Dan, additional, Lum, John, additional, Brown, Sue A., additional, Pinsker, Jordan E., additional, Church, Mei Mei, additional, Levy, Carol, additional, Lam, David, additional, Kudva, Yogish C., additional, Buckingham, Bruce, additional, Forlenza, Gregory P., additional, Wadwa, R. Paul, additional, Laffel, Lori, additional, Doyle, Francis J., additional, DeVries, J. Hans, additional, Renard, Eric, additional, Cobelli, Claudio, additional, Boscari, Federico, additional, Del Favero, Simone, additional, and Kovatchev, Boris P., additional

Published
2019
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35. Day-and-night closed-loop glucose control in patients with type 1 diabetes under free-living conditions:results of a single-arm 1-month experience compared with a previously reported feasibility study of evening and night at home

Author

Renard, Eric, Farret, Anne, Kropff, Jort, Bruttomesso, Daniela, Messori, Mirko, Place, Jérôme, Visentin, Roberto, Calore, Roberta, Toffanin, Chiara, Di Palma, Federico, Lanzola, Giordano, Magni, Paolo, Boscari, Federico, Galasso, Silvia, Avogaro, Angelo, Keith-Hynes, Patrick, Kovatchev, Boris, Del Favero, Simone, Cobelli, Claudio, Magni, Lalo, DeVries, J. Hans, consortium, AP@home, 01 Internal and external specialisms, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CIC Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Génomique Fonctionnelle (IGF), and Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Insulin pump, Adult, Blood Glucose, Male, Pancreas, Artificial, medicine.medical_specialty, Evening, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Artificial pancreas, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Animal science, Insulin Infusion Systems, Endocrinology, Internal medicine, Diabetes mellitus, Internal Medicine, Advanced and Specialized Nursing, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Morning, Glycemic, Type 1 diabetes, Cross-Over Studies, business.industry, Blood Glucose Self-Monitoring, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Middle Aged, medicine.disease, Crossover study, Circadian Rhythm, Diabetes and Metabolism, Diabetes Mellitus, Type 1, Social Conditions, Feasibility Studies, Female, business, Algorithms
Abstract

OBJECTIVE After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month. RESEARCH DESIGN AND METHODS Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9–10 mmol/L) over 24 h as the primary end point. RESULTS Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively). CONCLUSIONS D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.

Published
2016

36. THE SOCIAL ACCEPTANCE OF FUTURE ARTIFICIAL PANCREAS TECHNOLOGY: PARENTS' PERCEPTIONS OF PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS)

Author

Troncone, A, Bonfanti, R, Iafusco, D, Rabbone, I, Sabbion, A, Schiaffini, R, Galderisi, Alfonso, Marigliano, M, Rapini, N, Rigamonti, A, Tinti, D, Vallone, Valeria, Zanfardino, A, Boscari, Federico, DEL FAVERO, Simone, Galasso, Silvia, Lanzola, G, Messori, M, Di Palma, F, Visentin, Roberto, Calore, Roberta, Leal, Y, Magni, L, Chernavvsky, D, Quaglini, S, Cobelli, Claudio, and Bruttomesso, Daniela

Published
2016

37. PERCEIVED UTILITY OF A REMOTE MONITORING SYSTEM FOR PEDIATRIC SUBJECTS AFFECTED BY TYPE 1 DIABETES IN PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS) SUMMER CAMP

Author

Lanzola, G, Bonfanti, R, Iafusco, D, Rabbone, I, Sabbion, A, Schiaffini, R, Galderisi, Alfonso, Marigliano, M, Rapini, N, Rigamonti, A, Tinti, D, Vallone, Valeria, Zanfardino, A, Boscari, Federico, Galasso, Silvia, Troncone, A, DEL FAVERO, Simone, Visentin, Roberto, Calore, Roberta, Leal, My, Di Palma, F, Messori, M, Chernavvsky, D, Magni, L, Bruttomesso, Daniela, Quaglini, S, and Cobelli, Claudio

Published
2016

40. Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting

Author

Troncone, Alda, primary, Bonfanti, Riccardo, additional, Iafusco, Dario, additional, Rabbone, Ivana, additional, Sabbion, Alberto, additional, Schiaffini, Riccardo, additional, Galderisi, Alfonso, additional, Marigliano, Marco, additional, Rapini, Novella, additional, Rigamonti, Andrea, additional, Tinti, Davide, additional, Vallone, Valeria, additional, Zanfardino, Angela, additional, Boscari, Federico, additional, Del Favero, Simone, additional, Galasso, Silvia, additional, Lanzola, Giordano, additional, Messori, Mirko, additional, Di Palma, Federico, additional, Visentin, Roberto, additional, Calore, Roberta, additional, Leal, Yenny, additional, Magni, Lalo, additional, Losiouk, Eleonora, additional, Chernavvsky, Daniel, additional, Quaglini, Silvana, additional, Cobelli, Claudio, additional, and Bruttomesso, Daniela, additional

Published
2016
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41. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home

Author

Renard, Eric, primary, Farret, Anne, additional, Kropff, Jort, additional, Bruttomesso, Daniela, additional, Messori, Mirko, additional, Place, Jerome, additional, Visentin, Roberto, additional, Calore, Roberta, additional, Toffanin, Chiara, additional, Di Palma, Federico, additional, Lanzola, Giordano, additional, Magni, Paolo, additional, Boscari, Federico, additional, Galasso, Silvia, additional, Avogaro, Angelo, additional, Keith-Hynes, Patrick, additional, Kovatchev, Boris, additional, Del Favero, Simone, additional, Cobelli, Claudio, additional, Magni, Lalo, additional, and DeVries, J. Hans, additional

Published
2016
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42. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Author

Del Favero, Simone, primary, Boscari, Federico, additional, Messori, Mirko, additional, Rabbone, Ivana, additional, Bonfanti, Riccardo, additional, Sabbion, Alberto, additional, Iafusco, Dario, additional, Schiaffini, Riccardo, additional, Visentin, Roberto, additional, Calore, Roberta, additional, Moncada, Yenny Leal, additional, Galasso, Silvia, additional, Galderisi, Alfonso, additional, Vallone, Valeria, additional, Di Palma, Federico, additional, Losiouk, Eleonora, additional, Lanzola, Giordano, additional, Tinti, Davide, additional, Rigamonti, Andrea, additional, Marigliano, Marco, additional, Zanfardino, Angela, additional, Rapini, Novella, additional, Avogaro, Angelo, additional, Chernavvsky, Daniel, additional, Magni, Lalo, additional, Cobelli, Claudio, additional, and Bruttomesso, Daniela, additional

Published
2016
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43. Multinight “Bedside” Closed-Loop Control for Patients with Type 1 Diabetes

Author

Brown, Sue A., primary, Kovatchev, Boris P., additional, Breton, Marc D., additional, Anderson, Stacey M., additional, Keith-Hynes, Patrick, additional, Patek, Stephen D., additional, Jiang, Boyi, additional, Ben Brahim, Najib, additional, Vereshchetin, Paul, additional, Bruttomesso, Daniela, additional, Avogaro, Angelo, additional, Del Favero, Simone, additional, Boscari, Federico, additional, Galasso, Silvia, additional, Visentin, Roberto, additional, Monaro, Marco, additional, and Cobelli, Claudio, additional

Published
2015
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44. Individually Adaptive Artificial Pancreas in Subjects with Type 1 Diabetes: A One-Month Proof-of-Concept Trial in Free-Living Conditions.

Author

Messori, Mirko, Kropff, Jort, Del Favero, Simone, Place, Jerome, Visentin, Roberto, Calore, Roberta, Toffanin, Chiara, Di Palma, Federico, Lanzola, Giordano, Farret, Anne, Boscari, Federico, Galasso, Silvia, Avogaro, Angelo, Keith-Hynes, Patrick, Kovatchev, Boris P., Bruttomesso, Daniela, Magni, Lalo, DeVries, J. Hans, Renard, Eric, and Cobelli, Claudio

Published
2017
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45. Feasibility of Long-Term Closed-Loop Control: A Multicenter 6-Month Trial of 24/7 Automated Insulin Delivery.

Author

Kovatchev, Boris, Cheng, Peiyao, Anderson, Stacey M., Pinsker, Jordan E., Boscari, Federico, Buckingham, Bruce A., Doyle, Francis J., Hood, Korey K., Brown, Sue A., Breton, Marc D., Chernavvsky, Daniel, Bevier, Wendy C., Bradley, Paige K., Bruttomesso, Daniela, Del Favero, Simone, Calore, Roberta, Cobelli, Claudio, Avogaro, Angelo, Ly, Trang T., and Shanmugham, Satya

Published
2017
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46. Effects of Hypoglycemia on Circulating Stem and Progenitor Cells in Diabetic Patients.

Author

Fadini, Gian Paolo, Boscari, Federico, Cappellari, Roberta, Galasso, Silvia, Rigato, Mauro, Bonora, Benedetta Maria, D'Anna, Marianna, Bruttomesso, Daniela, and Avogaro, Angelo

Abstract

Iatrogenic hypoglycemia is the most common acute diabetic complication, and it significantly increases morbidity. In people with diabetes, reduction in the levels of circulating stem and progenitor cells predicts adverse outcomes.

Published
2018
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47. Multinational Home Use of Closed-Loop Control Is Safe and Effective.

Author

Anderson, Stacey M., Raghinaru, Dan, Pinsker, Jordan E., Boscari, Federico, Renard, Eric, Buckingham, Bruce A., Nimri, Revital, Doyle III, Francis J., Brown, Sue A., Keith-Hynes, Patrick, Breton, Marc D., Chernavvsky, Daniel, Bevier, Wendy C., Bradley, Paige K., Bruttomesso, Daniela, Del Favero, Simone, Calore, Roberta, Cobelli, Claudio, Avogaro, Angelo, and Farret, Anne

Subjects
CLOSED loop systems, PHYSIOLOGICAL effects of glucose, GLUCOSE, ARTIFICIAL pancreases, PANCREAS transplantation, TREATMENT of diabetes, THERAPEUTICS, BLOOD sugar analysis, HYPOGLYCEMIA, ARTIFICIAL organs, BLOOD sugar, BLOOD sugar monitoring, CLINICAL trials, COMPARATIVE studies, HYPOGLYCEMIC agents, INSULIN, INSULIN pumps, TYPE 1 diabetes, INTERNATIONAL relations, RESEARCH methodology, MEDICAL cooperation, RESEARCH, EVALUATION research, MOBILE apps, EQUIPMENT & supplies, PREVENTION
Abstract

Objective: To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes.Research Design and Methods: At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP.Results: Glycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively.Conclusions: CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day. [ABSTRACT FROM AUTHOR]

Published
2016
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49. Impaired hemodynamic response to meal intake in insulin-resistant subjects: an impedance cardiography approach.

Author

Kreutzenberg, Saula Vigili de, Fadini, Gian Paolo, Boscari, Federico, Rossi, Elisa, Guerra, Stefania, Sparacino, Giovanni, Cobelli, Claudio, Ceolotto, Giulio, Bottero, Matteo, and Avogoro, Angelo

Subjects
INSULIN, CARDIOGRAPHY, HYPERINSULINISM, INSULIN resistance, INSULIN aspart
Abstract

Background: In the postprandial state, insulin regulates metabolic and cardiovascular responses. In insulin resistance, the insulin action is impaired at both levels. However, postprandial hemodynamic responses are poorly characterized in this setting. Objective: We investigated fasting and postprandial cardiac and vascular hemodynamic responses in subjects with and without insulin resistance. Design: Sixty-six atherosclerosis-free, healthy volunteers were studied in a fasted state and =180 min after ingestion of a mixed meal. The insulin sensitivity index was determined by using a minimal model analysis; hemodynamic response was monitored by using continuous impedance cardiography that allowed a reliable beat-to-beat noninvasive evaluation of stroke volume, cardiac contractility, and several derived variables. Results: Subjects were divided into insulin-resistant (IR; n = 33) and insulin-sensitive (IS; n = 33) groups. After fasting, IR subjects had significantly higher values of systolic and diastolic blood pressures and the systemic vascular resistance index (SVRI) than did IS subjects. In the postprandial state, acute vasodilatation was comparable and synchronous (at 30 min) in IR and IS subjects (P = 0.209), but subsequent vascular tone recovery (30-180 min) was significantly impaired in IR subjects (P = 0.018), even after adjustment for age and sex (P = 0.031). Hemodynamic dysregulation was directly correlated with metabolic disturbances in the postprandial state. In basal and postprandial states, hemodynamic variables related to cardiac function were not significantly different in IR and IS subjects. Conclusions: IR subjects had a worse fasting vascular performance than did IS subjects. In the postprandial phase, insulin resistance was associated with a shorter duration of vasodilatation in the absence of an altered cardiac performance. Peripheral hemodynamic alterations in fasting and postprandial states may have a negative effect on cardiovascular performance in IR patients. [ABSTRACT FROM AUTHOR]

Published
2011

50. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Author

Giordano Lanzola, Davide Tinti, Simone Del Favero, Alfonso Galderisi, Angelo Avogaro, Yenny Leal Moncada, Daniela Bruttomesso, Silvia Galasso, Andrea Rigamonti, Lalo Magni, Valeria Vallone, Daniel R. Cherñavvsky, Federico Di Palma, Federico Boscari, Dario Iafusco, Marco Marigliano, Novella Rapini, Claudio Cobelli, Eleonora Losiouk, Ivana Rabbone, Riccardo Schiaffini, Riccardo Bonfanti, Roberta Calore, Roberto Visentin, Mirko Messori, A. Sabbion, Angela Zanfardino, Del Favero, S., Boscari, F., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, D., Schiaffini, R., Visentin, R., Calore, R., Moncada, Y. L., Galasso, S., Galderisi, A., Vallone, V., Di Palma, F., Losiouk, E., Lanzola, G., Tinti, D., Rigamonti, A., Marigliano, M., Zanfardino, A., Rapini, N., Avogaro, A., Chernavvsky, D., Magni, L., Cobelli, C., Bruttomesso, D., Del Favero, Simone, Boscari, Federico, Messori, Mirko, Rabbone, Ivana, Bonfanti, Riccardo, Sabbion, Alberto, Iafusco, Dario, Schiaffini, Riccardo, Visentin, Roberto, Calore, Roberta, Moncada, Yenny Leal, Galasso, Silvia, Galderisi, Alfonso, Vallone, Valeria, Di Palma, Federico, Losiouk, Eleonora, Lanzola, Giordano, Tinti, Davide, Rigamonti, Andrea, Marigliano, Marco, Zanfardino, Angela, Rapini, Novella, Avogaro, Angelo, Chernavvsky, Daniel, Magni, Lalo, Cobelli, Claudio, and Bruttomesso, Daniela

Subjects
Blood Glucose, Male, Pediatrics, Endocrinology, Diabetes and Metabolism, law.invention, Endocrinology, 0302 clinical medicine, Randomized controlled trial, law, Insulin, 030212 general & internal medicine, Child, education.field_of_study, Cross-Over Studies, Diabetes and Metabolism, Anesthesia, Child, Preschool, Artificial, Female, Algorithms, Type 1, Pancreas, Artificial, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, Hypoglycemia, Artificial pancreas, 03 medical and health sciences, Insulin Infusion Systems, Internal Medicine, Advanced and Specialized Nursing, Diabetes mellitus, medicine, Summer camp, Diabetes Mellitus, Humans, Hypoglycemic Agents, education, Preschool, Pancreas, Type 1 diabetes, business.industry, Diabetes Mellitus, Type 1, Feasibility Studies, medicine.disease, Crossover study, business
Abstract

OBJECTIVE The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old children during a camp. RESEARCH DESIGN AND METHODS A total of 30 children, 5- to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensor-augmented pump (SAP). RESULTS Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th–75th percentiles): 0.0% (0.0–2.2) vs. 2.2% (0.0–12.3) (P = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P = 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P = 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONS This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.

Published
2016

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