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10. Clinicians’ Feedback on Patient/Carer Experience After Switching of Growth Hormone Treatment in Pediatric Patients During COVID-19

Author

Blair J, Warth K, Suvarna Y, and Cappa M

Subjects
growth disorders, somatropin, virtual consultations, ease of use, norditropin®, Medicine (General), R5-920
Abstract

Joanne Blair, 1 Kelly Warth, 2 Yashasvi Suvarna, 3 Marco Cappa 4 1Department of Endocrinology, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK; 2Instar, London, UK; 3Global Medical Affairs, Novo Nordisk Global Business Services (GBS), Bangalore, India; 4Endocrinology Unit, Bambino Gesù Children’s Hospital, IRCCS, Rome, ItalyCorrespondence: Joanne BlairDepartment of Endocrinology, Alder Hey Children’s NHS Foundation Trust, Liverpool, L12 2AP, UKTel +44 151 252 5335 Fax +44 151 282 4606Email Jo.Blair@alderhey.nhs.ukPurpose: This study investigated why some clinicians switched growth hormone (GH) brands in pediatric patients with GH-related disorders to Norditropin® since the start of the COVID-19 pandemic, the clinicians’ perceptions of the results, and whether observations from this period of disruption could inform clinical practice in the future.Patients and Methods: Clinicians (N=106) from the UK, France, Italy, and Japan who had switched at least one patient to Norditropin® from a GH therapy manufactured by a different pharmaceutical company between February and November 2020 participated. They completed an online survey and submitted patient report forms for up to three switched patients.Results: Since the start of COVID-19, 39– 54% of the reported consultations were virtual (ie, via telephone or online means) in the UK, France, and Italy. Overall, 17% of patients seen by respondents in the survey were switched to a different GH brand; approximately two-thirds of switches were to Norditropin®. Clinicians’ top considerations in choosing a GH brand were patient/carer feedback, patient support programs, and the need for easy-to-use therapies in the context of virtual consultations. The top reasons for switching patients to Norditropin® included ease of use, device features and benefits, better patient/carer feedback, and ease of training in device use via virtual consultations. Norditropin® was considered suitable for use in virtual or in-person consultations or a mixture of both. Based on patient/carer feedback, 66% of clinicians believed that patients preferred Norditropin® to their previous therapy in terms of overall satisfaction.Conclusion: In this survey, key considerations in prescribing GH therapy were ease of use and acceptability to patients and carers. If virtual consultations increasingly replace in-person ones, ease in training patients/carers in device use will be particularly important. A majority of clinicians considered that their patients preferred Norditropin® to their previous therapy.Keywords: growth disorders, somatropin, virtual consultations, ease of use, Norditropin®

Published
2021

11. Autoimmune polyendocrine syndrome type 1: an Italian survey on 158 patients

Author

Garelli, S., Dalla Costa, M., Sabbadin, C., Barollo, S., Rubin, B., Scarpa, R., Masiero, S., Fierabracci, A., Bizzarri, C., Crinò, A., Cappa, M., Valenzise, M., Meloni, A., De Bellis, A. M., Giordano, C., Presotto, F., Perniola, R., Capalbo, D., Salerno, M. C., Stigliano, A., Radetti, G., Camozzi, V., Greggio, N. A., Bogazzi, F., Chiodini, I., Pagotto, U., Black, S. K., Chen, S., Rees Smith, B., Furmaniak, J., Weber, G., Pigliaru, F., De Sanctis, L., Scaroni, C., and Betterle, C.

Published
2021
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20. The use of prohibited substances for therapeutic reasons in athletes affected by endocrine diseases and disorders: the therapeutic use exemption (TUE) in clinical endocrinology

Author

Di Luigi, L., Pigozzi, F., Sgrò, P., Frati, L., Di Gianfrancesco, A., and Cappa, M.

Abstract

To protect sporting ethics and athletes’ health, the World Anti-Doping Agency (WADA) produced the World Anti-Doping Code and The Prohibited List of substances and methods forbidden in sports. In accordance with the International Standards for Therapeutic Use Exemption (ISTUE), to avoid rule violations and sanctions, athletes affected by different endocrine diseases and disorders (e.g., adrenal insufficiency, diabetes, male hypogonadisms, pituitary deficit, thyroid diseases, etc.) who need to use a prohibited substance for therapeutic reasons (e.g., medical treatments, surgical procedures, clinical diagnostic investigations) must apply to their respective Anti-Doping Organizations (ADOs) to obtain a Therapeutic Use Exemption (TUE), if specific criteria are respected. The physicians who treat these athletes (i.e., endocrinologists, andrologists and diabetologists) are highly involved in these procedures and should be aware of their specific role and responsibility in applying for a TUE, and in adequately monitoring unhealthy athletes treated with prohibited substances. In this paper, the prohibited substances commonly used for therapeutic reasons in endocrine diseases and disorders (e.g., corticotropins, beta-blockers, glucocorticoids, hCG, insulin, GnRH, rhGH, testosterone, etc.), the role of physicians in the TUE application process and the general criteria used by ADO-Therapeutic Use Exemption Committees (TUECs) for granting a TUE are described.

Published
2024
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24. Efficacy and safety of growth hormone treatment in children with short stature: the Italian cohort of the GeNeSIS clinical study

Author

Cappa, M., Iughetti, L., Loche, S., Maghnie, M., Vottero, A., Antoniazzi, Franco, Beccaria, Luciano, Bernasconi, Sergio, Caggiano, Domenico, Caruso-Nicoletti, Manuela, Catucci, Alessandra, Chiarelli, Francesco, Cianfarani, Stefano, Colucci, Anna Rita, De Rienzo, Francesca, Di Pumpo, Raffaele, Di Stasio, Alessandra, Farello, Giovanni, Felici, Leonardo, Femiano, Pasquale, Garagantini, Luigi, Giavoli, Claudia, Greggio, Nella Augusta, Guazzarotti, Laura, Larizza, Daniela, Licenziati, Maria Rosaria, Lonero, Antonella, Maggio, Maria Cristina, Marsciani, Alberto, Matarazzo, Patrizia, Mazzanti, Laura, Messini, Beatrice, Napoli, Flavia, Pasquino, Anna Maria, Perrone, Laura, Pilia, Sabrina, Pilotta, Alba, Piran, Marzia, Pozzobon, Gabriella, Predieri, Barbara, Sacco, Michele, Salerno, Mariacarolina, Tirendi, Antonina, Ubertini, Graziamaria, Vannelli, Silvia, Wasniewska, Malgorzata, Zampolli, Maria, Zanotti, Martina, Zuccotti, Gianvincenzo, and GeNeSIS National Board on behalf of the GeNeSIS Italian Investigators

Published
2016
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25. Long-Term Efficacy of T3 Analogue Triac in Children and Adults With MCT8 Deficiency: A Real-Life Retrospective Cohort Study.

Author

van Geest, FS, Groeneweg, S, van den Akker, ELT, Bacos, I, Barca, D, van den Berg, SAA, Bertini, E, Brunner, D, Brunetti-Pierri, N, Cappa, M, Cappuccio, G, Chatterjee, K, Chesover, AD, Christian, P, Coutant, R, Craiu, D, Crock, P, Dewey, C, Dica, A, Dimitri, P, Dubey, R, Enderli, A, Fairchild, J, Gallichan, J, Garibaldi, LR, George, B, Hackenberg, A, Heinrich, B, Huynh, T, Kłosowska, A, Lawson-Yuen, A, Linder-Lucht, M, Lyons, G, Monti Lora, F, Moran, C, Müller, KE, Paone, L, Paul, PG, Polak, M, Porta, F, Reinauer, C, de Rijke, YB, Seckold, R, Menevşe, TS, Simm, P, Simon, A, Spada, M, Stoupa, A, Szeifert, L, Tonduti, D, van Toor, H, Turan, S, Vanderniet, J, de Waart, M, van der Wal, R, van der Walt, A, van Wermeskerken, A-M, Wierzba, J, Zibordi, F, Zung, A, Peeters, RP, Visser, WE, van Geest, FS, Groeneweg, S, van den Akker, ELT, Bacos, I, Barca, D, van den Berg, SAA, Bertini, E, Brunner, D, Brunetti-Pierri, N, Cappa, M, Cappuccio, G, Chatterjee, K, Chesover, AD, Christian, P, Coutant, R, Craiu, D, Crock, P, Dewey, C, Dica, A, Dimitri, P, Dubey, R, Enderli, A, Fairchild, J, Gallichan, J, Garibaldi, LR, George, B, Hackenberg, A, Heinrich, B, Huynh, T, Kłosowska, A, Lawson-Yuen, A, Linder-Lucht, M, Lyons, G, Monti Lora, F, Moran, C, Müller, KE, Paone, L, Paul, PG, Polak, M, Porta, F, Reinauer, C, de Rijke, YB, Seckold, R, Menevşe, TS, Simm, P, Simon, A, Spada, M, Stoupa, A, Szeifert, L, Tonduti, D, van Toor, H, Turan, S, Vanderniet, J, de Waart, M, van der Wal, R, van der Walt, A, van Wermeskerken, A-M, Wierzba, J, Zibordi, F, Zung, A, Peeters, RP, and Visser, WE

Abstract

CONTEXT: Patients with mutations in thyroid hormone transporter MCT8 have developmental delay and chronic thyrotoxicosis associated with being underweight and having cardiovascular dysfunction. OBJECTIVE: Our previous trial showed improvement of key clinical and biochemical features during 1-year treatment with the T3 analogue Triac, but long-term follow-up data are needed. METHODS: In this real-life retrospective cohort study, we investigated the efficacy of Triac in MCT8-deficient patients in 33 sites. The primary endpoint was change in serum T3 concentrations from baseline to last available measurement. Secondary endpoints were changes in other thyroid parameters, anthropometric parameters, heart rate, and biochemical markers of thyroid hormone action. RESULTS: From October 15, 2014 to January 1, 2021, 67 patients (median baseline age 4.6 years; range, 0.5-66) were treated up to 6 years (median 2.2 years; range, 0.2-6.2). Mean T3 concentrations decreased from 4.58 (SD 1.11) to 1.66 (0.69) nmol/L (mean decrease 2.92 nmol/L; 95% CI, 2.61-3.23; P < 0.0001; target 1.4-2.5 nmol/L). Body-weight-for-age exceeded that of untreated historical controls (mean difference 0.72 SD; 95% CI, 0.36-1.09; P = 0.0002). Heart-rate-for-age decreased (mean difference 0.64 SD; 95% CI, 0.29-0.98; P = 0.0005). SHBG concentrations decreased from 245 (99) to 209 (92) nmol/L (mean decrease 36 nmol/L; 95% CI, 16-57; P = 0.0008). Mean creatinine concentrations increased from 32 (11) to 39 (13) µmol/L (mean increase 7 µmol/L; 95% CI, 6-9; P < 0.0001). Mean creatine kinase concentrations did not significantly change. No drug-related severe adverse events were reported. CONCLUSIONS: Key features were sustainably alleviated in patients with MCT8 deficiency across all ages, highlighting the real-life potential of Triac for MCT8 deficiency.

Published
2022

26. Prenatal dexamethasone treatment for classic 21-hydroxylase deficiency in Europe

Author

Nowotny, H., Neumann, U., Tardy-Guidollet, V., Ahmed, S.F., Baronio, F., Battelino, T., Bertherat, J., Blankenstein, O., Bonomi, M., Bouvattier, C., Perrière, A. Brac de la, Brucker, S., Cappa, M., Chanson, P., Claahsen-van der Grinten, H.L., Colao, A., Cools, M., Davies, J.H., Dörr, H.G., Fenske, W.K., Ghigo, E., Giordano, R., Gravholt, C.H., Huebner, A., Husebye, E.S., Igbokwe, R., Juul, A., Kiefer, F.W., Léger, J., Menassa, R., Meyer, G., Neocleous, V., Phylactou, L.A., Rohayem, J., Russo, G., Scaroni, C., Touraine, P., Unger, N., Vojtková, J., Yeste, D., Lajic, S., Reisch, N., Nowotny, H., Neumann, U., Tardy-Guidollet, V., Ahmed, S.F., Baronio, F., Battelino, T., Bertherat, J., Blankenstein, O., Bonomi, M., Bouvattier, C., Perrière, A. Brac de la, Brucker, S., Cappa, M., Chanson, P., Claahsen-van der Grinten, H.L., Colao, A., Cools, M., Davies, J.H., Dörr, H.G., Fenske, W.K., Ghigo, E., Giordano, R., Gravholt, C.H., Huebner, A., Husebye, E.S., Igbokwe, R., Juul, A., Kiefer, F.W., Léger, J., Menassa, R., Meyer, G., Neocleous, V., Phylactou, L.A., Rohayem, J., Russo, G., Scaroni, C., Touraine, P., Unger, N., Vojtková, J., Yeste, D., Lajic, S., and Reisch, N.

Abstract

Contains fulltext : 283126.pdf (Publisher’s version ) (Open Access), OBJECTIVE: To assess the current medical practice in Europe regarding prenatal dexamethasone (Pdex) treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. DESIGN AND METHODS: A questionnaire was designed and distributed, including 17 questions collecting quantitative and qualitative data. Thirty-six medical centres from 14 European countries responded and 30 out of 36 centres were reference centres of the European Reference Network on Rare Endocrine Conditions, EndoERN. RESULTS: Pdex treatment is currently provided by 36% of the surveyed centres. The treatment is initiated by different specialties, that is paediatricians, endocrinologists, gynaecologists or geneticists. Regarding the starting point of Pdex, 23% stated to initiate therapy at 4-5 weeks postconception (wpc), 31% at 6 wpc and 46 % as early as pregnancy is confirmed and before 7 wpc at the latest. A dose of 20 µg/kg/day is used. Dose distribution among the centres varies from once to thrice daily. Prenatal diagnostics for treated cases are conducted in 72% of the responding centres. Cases treated per country and year vary between 0.5 and 8.25. Registries for long-term follow-up are only available at 46% of the centres that are using Pdex treatment. National registries are only available in Sweden and France. CONCLUSIONS: This study reveals a high international variability and discrepancy in the use of Pdex treatment across Europe. It highlights the importance of a European cooperation initiative for a joint international prospective trial to establish evidence-based guidelines on prenatal diagnostics, treatment and follow-up of pregnancies at risk for CAH.

Published
2022

27. Case Report: Precision COVID-19 Immunization Strategy to Overcome Individual Fragility: A Case of Generalized Lipodystrophy Type 4

Author

Zaffina, S., Piano Mortari, E., Di Prinzio, R. R., Cappa, M., Novelli, A., Agolini, E., Raponi, M., Dallapiccola, B., Locatelli, Franco, Perno, C. F., Carsetti, R., Locatelli F. (ORCID:0000-0002-7976-3654), Zaffina, S., Piano Mortari, E., Di Prinzio, R. R., Cappa, M., Novelli, A., Agolini, E., Raponi, M., Dallapiccola, B., Locatelli, Franco, Perno, C. F., Carsetti, R., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

A 48-year-old patient affected with congenital generalized lipodystrophy type 4 failed to respond to two doses of the BNT162b2 vaccine, consisting of lipid nanoparticle encapsulated mRNA. As the disease is caused by biallelic variants of CAVIN1, a molecule indispensable for lipid endocytosis and regulation, we complemented the vaccination cycle with a single dose of the Ad26.COV2 vaccine. Adenovirus-based vaccine entry is mediated by the interaction with adenovirus receptors and transport occurs in clathrin-coated pits. Ten days after Ad26.COV2 administration, S- and RBD-specific antibodies and high-affinity memory B cells increased significantly to values close to those observed in Health Care Worker controls.

Published
2022

29. Growth hormone treatment of adolescents with growth hormone deficiency (GHD) during the transition period: results of a survey among adult and paediatric endocrinologists from Italy. Endorsed by SIEDP/ISPED, AME, SIE, SIMA

Author

Aimaretti, G., Attanasio, R., Cannavò, S., Nicoletti, M. C., Castello, R., Di Somma, C., Garofalo, P., Iughetti, L., Loche, S., Maghnie, M., Mazzanti, L., Saggese, G., Salerno, M., Tonini, G., Toscano, V., Zucchini, S., and Cappa, M.

Published
2015
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37. Prevalence of copy number variants (CNVs) and rhGH treatment efficacy in an Italian cohort of children born small for gestational age (SGA) with persistent short stature associated with a complex clinical phenotype

Author

Inzaghi, E., primary, Deodati, A., additional, Loddo, S., additional, Mucciolo, M., additional, Verdecchia, F., additional, Sallicandro, E., additional, Catino, G., additional, Cappa, M., additional, Novelli, A., additional, and Cianfarani, S., additional

Published
2021
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39. Supplementary material to: Long-term efficacy of T3 analogue Triac in children and adults with MCT8 deficiency: a real-life retrospective cohort study

Author

Geest, F.S. (Ferdy) van, Groeneweg, S. (Stefan), Akker, E.L.T. (Erica) van den, Bacos, I. (Iuliu), Barca, D. (Diana), Berg, S.A.A. (Sjoerd) van den, Bertini, E. (Enrico), Brunner, D. (Doris), Brunetti-Pierri, N. (Nicola), Cappa, M. (Marco), Cappuccio, G. (Gerarda), Chatterjee, K. (Krishna), Chesover, A.D. (Alexander), Christian, P. (Peter), Coutant, R. (Régis), Craiu, D. (Dana), Crock, P. (Patricia), Dewey, C. (Cheyenne), Dica, A. (Alice), Dimitri, P. (Paul), Dubey, R. (Rachana), Enderli, A. (Anina), Fairchild, J. (Jan), Gallichan, J. (Jonathan), Garibaldi, L.R. (Luigi), George, B. (Belinda), Hackenberg, A. (Annette), Heinrich, B. (Bianka), Huynh, Tony (T.), Klosowska, A. (Anna), Lawson-Yuen, A. (Amy), Linder-Lucht, M. (Michaela), Lyons, G. (Greta), Monti Lora, F. (Felipe), Moran, C. (Carla), Müller, K. (Katalin), Paone, L. (Laura), Paul, P.G. (Praveen), Polak, M. (Michel), Porta, F. (Francesco), Reinauer, C. (Christina), Rijke, Y.B. (Yolanda) de, Seckold, R. (Rowen), Seven Menevse, T. (Tuba), Simm, P. (Peter), Simon, A. (Anna), Spada, M. (Marco), Stoupa, A. (Athanasia), Szeifert, L. (Lilla), Tonduti, D. (Davide), Toor, H. (Hans) van, Turan, S. (Serap), Vanderniet, J. (Joel), Waart, M. (Monique) de, Wal, R. (Ronald) van der, Walt, A. (Adri) van der, Wermeskerken, A-M. (Anne-Marie) van, Wierzba, J. (Jolanta), Zibordi, F. (Federica), Zung, A. (Amnon), Peeters, R.P. (Robin), Visser, W.E. (Edward), Geest, F.S. (Ferdy) van, Groeneweg, S. (Stefan), Akker, E.L.T. (Erica) van den, Bacos, I. (Iuliu), Barca, D. (Diana), Berg, S.A.A. (Sjoerd) van den, Bertini, E. (Enrico), Brunner, D. (Doris), Brunetti-Pierri, N. (Nicola), Cappa, M. (Marco), Cappuccio, G. (Gerarda), Chatterjee, K. (Krishna), Chesover, A.D. (Alexander), Christian, P. (Peter), Coutant, R. (Régis), Craiu, D. (Dana), Crock, P. (Patricia), Dewey, C. (Cheyenne), Dica, A. (Alice), Dimitri, P. (Paul), Dubey, R. (Rachana), Enderli, A. (Anina), Fairchild, J. (Jan), Gallichan, J. (Jonathan), Garibaldi, L.R. (Luigi), George, B. (Belinda), Hackenberg, A. (Annette), Heinrich, B. (Bianka), Huynh, Tony (T.), Klosowska, A. (Anna), Lawson-Yuen, A. (Amy), Linder-Lucht, M. (Michaela), Lyons, G. (Greta), Monti Lora, F. (Felipe), Moran, C. (Carla), Müller, K. (Katalin), Paone, L. (Laura), Paul, P.G. (Praveen), Polak, M. (Michel), Porta, F. (Francesco), Reinauer, C. (Christina), Rijke, Y.B. (Yolanda) de, Seckold, R. (Rowen), Seven Menevse, T. (Tuba), Simm, P. (Peter), Simon, A. (Anna), Spada, M. (Marco), Stoupa, A. (Athanasia), Szeifert, L. (Lilla), Tonduti, D. (Davide), Toor, H. (Hans) van, Turan, S. (Serap), Vanderniet, J. (Joel), Waart, M. (Monique) de, Wal, R. (Ronald) van der, Walt, A. (Adri) van der, Wermeskerken, A-M. (Anne-Marie) van, Wierzba, J. (Jolanta), Zibordi, F. (Federica), Zung, A. (Amnon), Peeters, R.P. (Robin), and Visser, W.E. (Edward)

Published
2021

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

Author

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, 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. 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. 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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., and Marigliano M.

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. <58 mmol/mol for age <18 years and [removed]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

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