{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T12:30:04Z","timestamp":1792153804572,"version":"4.4.0"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T00:00:00Z","timestamp":1749772800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T00:00:00Z","timestamp":1749772800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100010724","name":"Health Systems Research Institute","doi-asserted-by":"crossref","award":["Health Systems Research Institute"],"award-info":[{"award-number":["Health Systems Research Institute"]}],"id":[{"id":"10.13039\/501100010724","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Diabetes Association of Thailand","award":["Diabetes Association of Thailand"],"award-info":[{"award-number":["Diabetes Association of Thailand"]}]},{"name":"Thai Society for Pediatric Endocrinology","award":["Thai Society for Pediatric Endocrinology"],"award-info":[{"award-number":["Thai Society for Pediatric Endocrinology"]}]},{"name":"National Health Security Office","award":["National Health Security Office"],"award-info":[{"award-number":["National Health Security Office"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sleep Breath"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>Sleep disturbances is common in type 1 diabetes (T1D) and can be associated with poor glycemic control, and possibly hypoglycemia. This study aims to investigate whether poor sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI), was associated with glycemic control or severe hypoglycemia in T1D individuals.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>This one-year prospective cohort study included 221 (148\u00a0F\/63\u00a0M) T1D participants (aged\u2009\u2265\u200913 years), receiving intensive insulin therapy. A1C levels were obtained at baseline and during the 12-month follow-up. Incidences of diabetic ketoacidosis (DKA) and severe hypoglycemia were collected.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The mean age of participants was 21.4\u2009\u00b1\u20098.9 years, with a baseline A1C of 9.27\u2009\u00b1\u20092.61%. Poor sleep quality was reported in 33.0% of participants. A1C levels improved over the one-year follow-up, but there was no significant difference in A1C reduction between those with good vs. poor sleep quality (-0.42\u2009\u00b1\u20091.73 vs. -0.42\u2009\u00b1\u20091.67, <jats:italic>P<\/jats:italic>\u2009=\u20090.835), nor in DKA incidence (<jats:italic>P<\/jats:italic>\u2009=\u20090.466). However, participants with poor sleep quality experienced more SH episodes (6.53 (2.45\u201317.41) vs. 0 per 100-person year, <jats:italic>P<\/jats:italic>\u2009=\u20090.01). After adjusting for age, body mass index, and glucose monitoring, each one-point increase in PSQI score was associated with a higher severe hypoglycemia risk (OR 1.31, 95%CI 1.13\u20131.52). Poor sleep quality predicted an increased risk of severe hypoglycemia (OR 24.54, 95%CI 1.31-459.29).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Poor sleep quality is common in T1D individuals and is a risk factor for incident SH. These findings highlight the importance of incorporating sleep assessment into routine T1D diabetes care and the need of targeted interventions to improve sleep quality in T1D individuals. These findings support the importance of addressing sleep quality in T1D management, particularly in relation to hypoglycemia risk.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s11325-025-03385-1","type":"journal-article","created":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T08:28:25Z","timestamp":1749803305000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Poor sleep quality is a predictor of severe hypoglycemia during comprehensive diabetes care in type 1 diabetes"],"prefix":"10.1007","volume":"29","author":[{"given":"Prapai","family":"Dejkhamron","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thipaporn","family":"Tharavanij","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Supawadee","family":"Likitmaskul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petch","family":"Rawdaree","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeerunda","family":"Santiprabhob","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaicharn","family":"Deerochanawong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wannee","family":"Nitiyanant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0686-1069","authenticated-orcid":false,"given":"Sirimon","family":"Reutrakul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of Thai-Type 1 Diabetes and Diabetes diagnosed Age before 30 years Registry, Care and Network (T1DDAR CN) committee and members","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,6,13]]},"reference":[{"key":"3385_CR1","doi-asserted-by":"publisher","first-page":"S77","DOI":"10.2337\/dc24-S005","volume":"47","author":"American Diabetes Association Professional Practice Committee","year":"2024","unstructured":"American Diabetes Association Professional Practice Committee (2024) Facilitating positive health behaviors and Well-being to improve health outcomes: standards of care in Diabetes-2024. Diabetes Care 47:S77\u2013S110. https:\/\/doi.org\/10.2337\/dc24-S005","journal-title":"Diabetes Care"},{"key":"3385_CR2","doi-asserted-by":"publisher","first-page":"10","DOI":"10.2337\/diaspect.29.1.10","volume":"29","author":"SS Farabi","year":"2016","unstructured":"Farabi SS (2016) Type 1 diabetes and sleep. Diabetes Spectr 29:10\u201313. https:\/\/doi.org\/10.2337\/diaspect.29.1.10","journal-title":"Diabetes Spectr"},{"key":"3385_CR3","doi-asserted-by":"publisher","first-page":"107988","DOI":"10.1016\/j.diabres.2019.107988","volume":"160","author":"V Suteau","year":"2020","unstructured":"Suteau V, Saulnier PJ, Wargny M, Gonder-Frederick L, Gand E, Chaillous L et al (2020) Association between sleep disturbances, fear of hypoglycemia and psychological well-being in adults with type 1 diabetes mellitus, data from cross-sectional VARDIA study. Diabetes Res Clin Pract 160:107988. https:\/\/doi.org\/10.1016\/j.diabres.2019.107988","journal-title":"Diabetes Res Clin Pract"},{"key":"3385_CR4","doi-asserted-by":"publisher","first-page":"108442","DOI":"10.1016\/j.diabres.2020.108442","volume":"169","author":"ER Hamburger","year":"2020","unstructured":"Hamburger ER, Goethals ER, Choudhary A, Jaser SS (2020) Sleep and depressive symptoms in adolescents with type 1 diabetes not meeting glycemic targets. Diabetes Res Clin Pract 169:108442. https:\/\/doi.org\/10.1016\/j.diabres.2020.108442","journal-title":"Diabetes Res Clin Pract"},{"key":"3385_CR5","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1016\/j.sleep.2016.03.019","volume":"23","author":"S Reutrakul","year":"2016","unstructured":"Reutrakul S, Thakkinstian A, Anothaisintawee T, Chontong S, Borel AL, Perfect MM et al (2016) Sleep characteristics in type 1 diabetes and associations with glycemic control: systematic review and meta-analysis. Sleep Med 23:26\u201345. https:\/\/doi.org\/10.1016\/j.sleep.2016.03.019","journal-title":"Sleep Med"},{"key":"3385_CR6","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1007\/s11892-021-01424-1","volume":"21","author":"B Zhu","year":"2021","unstructured":"Zhu B, Abu Irsheed GM, Martyn-Nemeth P, Reutrakul S (2021) Type 1 diabetes, sleep, and hypoglycemia. Curr Diab Rep 21:55. https:\/\/doi.org\/10.1007\/s11892-021-01424-1","journal-title":"Curr Diab Rep"},{"key":"3385_CR7","doi-asserted-by":"publisher","first-page":"1573","DOI":"10.2337\/dc09-2317","volume":"33","author":"E Donga","year":"2010","unstructured":"Donga E, van Dijk M, van Dijk JG, Biermasz NR, Lammers GJ, van Kralingen K et al (2010) Partial sleep restriction decreases insulin sensitivity in type 1 diabetes. Diabetes Care 33:1573\u20131577. https:\/\/doi.org\/10.2337\/dc09-2317","journal-title":"Diabetes Care"},{"key":"3385_CR8","doi-asserted-by":"publisher","first-page":"262","DOI":"10.1111\/pedi.12381","volume":"18","author":"RJ McDonough","year":"2017","unstructured":"McDonough RJ, Clements MA, DeLurgio SA, Patton SR (2017) Sleep duration and its impact on adherence in adolescents with type 1 diabetes mellitus. Pediatr Diabetes 18:262\u2013270. https:\/\/doi.org\/10.1111\/pedi.12381","journal-title":"Pediatr Diabetes"},{"key":"3385_CR9","doi-asserted-by":"publisher","first-page":"163","DOI":"10.1067\/mpd.2003.66","volume":"142","author":"G Pillar","year":"2003","unstructured":"Pillar G, Schuscheim G, Weiss R, Malhotra A, McCowen KC, Shlitner A et al (2003) Interactions between hypoglycemia and sleep architecture in children with type 1 diabetes mellitus. J Pediatr 142:163\u2013168. https:\/\/doi.org\/10.1067\/mpd.2003.66","journal-title":"J Pediatr"},{"key":"3385_CR10","doi-asserted-by":"publisher","first-page":"2159","DOI":"10.1007\/s00125-021-05500-9","volume":"64","author":"R Brandt","year":"2021","unstructured":"Brandt R, Park M, Wroblewski K, Quinn L, Tasali E, Cinar A (2021) Sleep quality and glycaemic variability in a real-life setting in adults with type 1 diabetes. Diabetologia 64:2159\u20132169. https:\/\/doi.org\/10.1007\/s00125-021-05500-9","journal-title":"Diabetologia"},{"key":"3385_CR11","doi-asserted-by":"publisher","first-page":"98","DOI":"10.34172\/hpp.2020.18","volume":"10","author":"M Mobasseri","year":"2020","unstructured":"Mobasseri M, Shirmohammadi M, Amiri T, Vahed N, Hosseini Fard H, Ghojazadeh M (2020) Prevalence and incidence of type 1 diabetes in the world: a systematic review and meta-analysis. Health Promot Perspect 10:98\u2013115. https:\/\/doi.org\/10.34172\/hpp.2020.18","journal-title":"Health Promot Perspect"},{"key":"3385_CR12","doi-asserted-by":"publisher","first-page":"322","DOI":"10.1177\/19322968211049783","volume":"17","author":"DJ DeSalvo","year":"2023","unstructured":"DeSalvo DJ, Noor N, Xie C, Corathers SD, Majidi S, McDonough RJ et al (2023) Patient demographics and clinical outcomes among type 1 diabetes patients using continuous glucose monitors: data from T1D exchange Real-World observational study. J Diabetes Sci Technol 17:322\u2013328. https:\/\/doi.org\/10.1177\/19322968211049783","journal-title":"J Diabetes Sci Technol"},{"key":"3385_CR13","doi-asserted-by":"publisher","first-page":"109868","DOI":"10.1016\/j.diabres.2022.109868","volume":"187","author":"SM Ng","year":"2022","unstructured":"Ng SM, Malene IV, Nilar M, Rassavong K, Dung Vu C, Hui Sieng Tan F et al (2022) Closing the type 1 diabetes gap in South-East Asia through government partnership working with non-government organisations. Diabetes Res Clin Pract 187:109868. https:\/\/doi.org\/10.1016\/j.diabres.2022.109868","journal-title":"Diabetes Res Clin Pract"},{"key":"3385_CR14","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1111\/jdi.13390","volume":"12","author":"P Dejkhamron","year":"2021","unstructured":"Dejkhamron P, Santiprabhob J, Likitmaskul S, Deerochanawong C, Rawdaree P, Tharavanij T et al (2021) Type 1 diabetes management and outcomes: A multicenter study in Thailand. J Diabetes Investig 12:516\u2013526. https:\/\/doi.org\/10.1111\/jdi.13390","journal-title":"J Diabetes Investig"},{"key":"3385_CR15","doi-asserted-by":"publisher","first-page":"717","DOI":"10.2147\/DMSO.S195916","volume":"12","author":"L Preechasuk","year":"2019","unstructured":"Preechasuk L, Sriussadaporn P, Likitmaskul S (2019) The Obstacles to diabetes self-management education and support from healthcare professionals\u2019 perspectives: a nationwide survey. Diabetes Metab Syndr Obes 12:717\u2013727. https:\/\/doi.org\/10.2147\/DMSO.S195916","journal-title":"Diabetes Metab Syndr Obes"},{"key":"3385_CR16","doi-asserted-by":"crossref","unstructured":"Dejkhamron P, Likitmaskul S, Deerochanawong C, Tharavanij T, Santiprabhob J, Kongkanka C et al (eds) Nationwide implementation of an effective therapy for T1DM by universal health coverage in a limited resource country international diabetes federation Congress 2019. Busan, South Korea","DOI":"10.26226\/morressier.5d9b6235ea541d6ca8494409"},{"key":"3385_CR17","doi-asserted-by":"publisher","first-page":"e14110","DOI":"10.1111\/jsr.14110","volume":"33","author":"O Promsod","year":"2024","unstructured":"Promsod O, Kositanurit W, Tabtieang T, Kulaputana O, Chirakalwasan N, Reutrakul S et al (2024) Impact of irregular sleep pattern, and sleep quality on glycaemic parameters and endothelial function in adolescents and young adults with type 1 diabetes. J Sleep Res 33:e14110. https:\/\/doi.org\/10.1111\/jsr.14110","journal-title":"J Sleep Res"},{"key":"3385_CR18","doi-asserted-by":"publisher","first-page":"438","DOI":"10.1111\/jsr.12393","volume":"25","author":"S Chontong","year":"2016","unstructured":"Chontong S, Saetung S, Reutrakul S (2016) Higher sleep variability is associated with poorer glycaemic control in patients with type 1 diabetes. J Sleep Res 25:438\u2013444. https:\/\/doi.org\/10.1111\/jsr.12393","journal-title":"J Sleep Res"},{"issue":"Suppl 3","key":"3385_CR19","first-page":"S57","volume":"97","author":"T Sitasuwan","year":"2014","unstructured":"Sitasuwan T, Bussaratid S, Ruttanaumpawan P, Chotinaiwattarakul W (2014) Reliability and validity of the Thai version of the Pittsburgh sleep quality index. J Med Assoc Thai 97(Suppl 3):S57\u201367","journal-title":"J Med Assoc Thai"},{"key":"3385_CR20","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1016\/j.sleep.2017.07.005","volume":"39","author":"SS Jaser","year":"2017","unstructured":"Jaser SS, Foster NC, Nelson BA, Kittelsrud JM, DiMeglio LA, Quinn M et al (2017) Sleep in children with type 1 diabetes and their parents in the T1D exchange. Sleep Med 39:108\u2013115. https:\/\/doi.org\/10.1016\/j.sleep.2017.07.005","journal-title":"Sleep Med"},{"key":"3385_CR21","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1590\/2359-3997000000013","volume":"59","author":"MT Barone","year":"2015","unstructured":"Barone MT, Wey D, Schorr F, Franco DR, Carra MK, Lorenzi Filho G et al (2015) Sleep and glycemic control in type 1 diabetes. Arch Endocrinol Metab 59:71\u201378. https:\/\/doi.org\/10.1590\/2359-3997000000013","journal-title":"Arch Endocrinol Metab"},{"key":"3385_CR22","doi-asserted-by":"publisher","first-page":"399","DOI":"10.1507\/endocrj.EJ21-0408","volume":"69","author":"M Ichikawa","year":"2022","unstructured":"Ichikawa M, Yamakawa T, Sakamoto R, Takahashi K, Suzuki J, Matsuura-Shinoda M et al (2022) A cross-sectional study of the relationship between quality of life and sleep quality in Japanese patients with type 1 diabetes mellitus. Endocr J 69:399\u2013406. https:\/\/doi.org\/10.1507\/endocrj.EJ21-0408","journal-title":"Endocr J"},{"key":"3385_CR23","doi-asserted-by":"publisher","first-page":"77","DOI":"10.3111\/13696998.2011.624144","volume":"15","author":"M Brod","year":"2012","unstructured":"Brod M, Christensen T, Bushnell DM (2012) Impact of nocturnal hypoglycemic events on diabetes management, sleep quality, and next-day function: results from a four-country survey. J Med Econ 15:77\u201386. https:\/\/doi.org\/10.3111\/13696998.2011.624144","journal-title":"J Med Econ"},{"key":"3385_CR24","doi-asserted-by":"publisher","first-page":"2160","DOI":"10.1007\/s00125-024-06233-1","volume":"67","author":"U Soholm","year":"2024","unstructured":"Soholm U, Broadley M, Zaremba N, Divilly P, Baumann PM, Mahmoudi Z et al (2024) The impact of hypoglycaemia on daily functioning among adults with diabetes: a prospective observational study using the Hypo-METRICS app. Diabetologia 67:2160\u20132174. https:\/\/doi.org\/10.1007\/s00125-024-06233-1","journal-title":"Diabetologia"},{"key":"3385_CR25","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1093\/abm\/kaz044","volume":"54","author":"EL Tracy","year":"2020","unstructured":"Tracy EL, Berg CA, Kent De Grey RG, Butner J, Litchman ML, Allen NA et al (2020) The role of Self-regulation failures and Self-care in the link between daily sleep quality and blood glucose among adults with type 1 diabetes. Ann Behav Med 54:249\u2013257. https:\/\/doi.org\/10.1093\/abm\/kaz044","journal-title":"Ann Behav Med"},{"key":"3385_CR26","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1111\/pedi.12991","volume":"21","author":"SS Jaser","year":"2020","unstructured":"Jaser SS, Hamburger ER, Bergner EM, Williams R, Slaughter JC, Simmons JH et al (2020) Sleep coach intervention for teens with type 1 diabetes: randomized pilot study. Pediatr Diabetes 21:473\u2013478. https:\/\/doi.org\/10.1111\/pedi.12991","journal-title":"Pediatr Diabetes"},{"key":"3385_CR27","doi-asserted-by":"publisher","first-page":"304","DOI":"10.1093\/jpepsy\/jsaa105","volume":"46","author":"SS Jaser","year":"2021","unstructured":"Jaser SS, Bergner EM, Hamburger ER, Bhatia S, Lyttle M, Bell GE et al (2021) Pilot trial of a Sleep-Promoting intervention for children with type 1 diabetes. J Pediatr Psychol 46:304\u2013313. https:\/\/doi.org\/10.1093\/jpepsy\/jsaa105","journal-title":"J Pediatr Psychol"},{"key":"3385_CR28","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1177\/26350106221136495","volume":"49","author":"P Martyn-Nemeth","year":"2023","unstructured":"Martyn-Nemeth P, Duffecy J, Quinn L, Steffen A, Baron K, Chapagai S et al (2023) Sleep-Opt-In: A randomized controlled pilot study to improve sleep and glycemic variability in adults with type 1 diabetes. Sci Diabetes Self Manag Care 49:11\u201322. https:\/\/doi.org\/10.1177\/26350106221136495","journal-title":"Sci Diabetes Self Manag Care"},{"key":"3385_CR29","doi-asserted-by":"publisher","first-page":"794","DOI":"10.1089\/dia.2020.0057","volume":"22","author":"EC Cobry","year":"2020","unstructured":"Cobry EC, Hamburger E, Jaser SS (2020) Impact of the hybrid Closed-Loop system on sleep and quality of life in youth with type 1 diabetes and their parents. Diabetes Technol Ther 22:794\u2013800. https:\/\/doi.org\/10.1089\/dia.2020.0057","journal-title":"Diabetes Technol Ther"},{"key":"3385_CR30","doi-asserted-by":"publisher","first-page":"1052","DOI":"10.1177\/19322968241267823","volume":"18","author":"B Kulzer","year":"2024","unstructured":"Kulzer B, Freckmann G, Ziegler R, Schnell O, Glatzer T, Heinemann L (2024) Nocturnal hypoglycemia in the era of continuous glucose monitoring. J Diabetes Sci Technol 18:1052\u20131060. https:\/\/doi.org\/10.1177\/19322968241267823","journal-title":"J Diabetes Sci Technol"}],"container-title":["Sleep and Breathing"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11325-025-03385-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11325-025-03385-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11325-025-03385-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T14:13:23Z","timestamp":1756390403000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11325-025-03385-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,13]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["3385"],"URL":"https:\/\/doi.org\/10.1007\/s11325-025-03385-1","relation":{},"ISSN":["1520-9512","1522-1709"],"issn-type":[{"value":"1520-9512","type":"print"},{"value":"1522-1709","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,13]]},"assertion":[{"value":"24 February 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 May 2025","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 June 2025","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 June 2025","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study complied with the Declaration of Helsinki and received approval from the Central Research Ethics Committee CREC021\/61BRm) and by the institutional review board of each participating center. Informed consent\/assent was obtained from all participants or the parents\/legal guardians.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}],"article-number":"214"}}