{"title":"在儿科人群中通过心电图进行无创血糖事件检测的人工智能：研究方案。","authors":"Martina Andellini, Salman Haleem, Massimiliano Angelini, Matteo Ritrovato, Riccardo Schiaffini, Ernesto Iadanza, Leandro Pecchia","doi":"10.1007/s12553-022-00719-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control. To reduce the risk of adverse events, patients need to achieve the best possible glycaemic management through frequent blood glucose monitoring with finger prick or Continuous Glucose Monitoring (CGM) systems. However, several non-invasive techniques have been proposed aiming at exploiting changes in physiological parameters based on glucose levels. The overall objective of this study is to validate an artificial intelligence (AI) based algorithm to detect glycaemic events using ECG signals collected through non-invasive device.</p><p><strong>Methods: </strong>This study will enrol T1D paediatric participants who already use CGM. Participants will wear an additional non-invasive wearable device for recording physiological data and respiratory rate. Glycaemic measurements driven through ECG variables are the main outcomes. Data collected will be used to design, develop and validate the personalised and generalized classifiers based on a deep learning (DL) AI algorithm, able to automatically detect hypoglycaemic events by using few ECG heartbeats recorded with wearable devices.</p><p><strong>Results: </strong>Data collection is expected to be completed approximately by June 2023. It is expected that sufficient data will be collected to develop and validate the AI algorithm.</p><p><strong>Conclusion: </strong>This is a validation study that will perform additional tests on a larger diabetes sample population to validate the previous pilot results that were based on four healthy adults, providing evidence on the reliability of the AI algorithm in detecting glycaemic events in paediatric diabetic patients in free-living conditions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT03936634. Registered on 11 March 2022, retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT05278143?titles=AI+for+Glycemic+Events+Detection+Via+ECG+in+a+Pediatric+Population&draw=2&rank=1.</p><p><strong>Supplementary information: </strong>The online version contains supplementary material available at 10.1007/s12553-022-00719-x.</p>","PeriodicalId":12941,"journal":{"name":"Health and Technology","volume":"13 1","pages":"145-154"},"PeriodicalIF":3.1000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899724/pdf/","citationCount":"0","resultStr":"{\"title\":\"Artificial intelligence for non-invasive glycaemic-events detection via ECG in a paediatric population: study protocol.\",\"authors\":\"Martina Andellini, Salman Haleem, Massimiliano Angelini, Matteo Ritrovato, Riccardo Schiaffini, Ernesto Iadanza, Leandro Pecchia\",\"doi\":\"10.1007/s12553-022-00719-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control. To reduce the risk of adverse events, patients need to achieve the best possible glycaemic management through frequent blood glucose monitoring with finger prick or Continuous Glucose Monitoring (CGM) systems. However, several non-invasive techniques have been proposed aiming at exploiting changes in physiological parameters based on glucose levels. The overall objective of this study is to validate an artificial intelligence (AI) based algorithm to detect glycaemic events using ECG signals collected through non-invasive device.</p><p><strong>Methods: </strong>This study will enrol T1D paediatric participants who already use CGM. Participants will wear an additional non-invasive wearable device for recording physiological data and respiratory rate. Glycaemic measurements driven through ECG variables are the main outcomes. Data collected will be used to design, develop and validate the personalised and generalized classifiers based on a deep learning (DL) AI algorithm, able to automatically detect hypoglycaemic events by using few ECG heartbeats recorded with wearable devices.</p><p><strong>Results: </strong>Data collection is expected to be completed approximately by June 2023. It is expected that sufficient data will be collected to develop and validate the AI algorithm.</p><p><strong>Conclusion: </strong>This is a validation study that will perform additional tests on a larger diabetes sample population to validate the previous pilot results that were based on four healthy adults, providing evidence on the reliability of the AI algorithm in detecting glycaemic events in paediatric diabetic patients in free-living conditions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT03936634. Registered on 11 March 2022, retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT05278143?titles=AI+for+Glycemic+Events+Detection+Via+ECG+in+a+Pediatric+Population&draw=2&rank=1.</p><p><strong>Supplementary information: </strong>The online version contains supplementary material available at 10.1007/s12553-022-00719-x.</p>\",\"PeriodicalId\":12941,\"journal\":{\"name\":\"Health and Technology\",\"volume\":\"13 1\",\"pages\":\"145-154\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899724/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Health and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s12553-022-00719-x\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/1/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL INFORMATICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12553-022-00719-x","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/1/23 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
Artificial intelligence for non-invasive glycaemic-events detection via ECG in a paediatric population: study protocol.
Purpose: Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control. To reduce the risk of adverse events, patients need to achieve the best possible glycaemic management through frequent blood glucose monitoring with finger prick or Continuous Glucose Monitoring (CGM) systems. However, several non-invasive techniques have been proposed aiming at exploiting changes in physiological parameters based on glucose levels. The overall objective of this study is to validate an artificial intelligence (AI) based algorithm to detect glycaemic events using ECG signals collected through non-invasive device.
Methods: This study will enrol T1D paediatric participants who already use CGM. Participants will wear an additional non-invasive wearable device for recording physiological data and respiratory rate. Glycaemic measurements driven through ECG variables are the main outcomes. Data collected will be used to design, develop and validate the personalised and generalized classifiers based on a deep learning (DL) AI algorithm, able to automatically detect hypoglycaemic events by using few ECG heartbeats recorded with wearable devices.
Results: Data collection is expected to be completed approximately by June 2023. It is expected that sufficient data will be collected to develop and validate the AI algorithm.
Conclusion: This is a validation study that will perform additional tests on a larger diabetes sample population to validate the previous pilot results that were based on four healthy adults, providing evidence on the reliability of the AI algorithm in detecting glycaemic events in paediatric diabetic patients in free-living conditions.
Trial registration: ClinicalTrials.gov identifier: NCT03936634. Registered on 11 March 2022, retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT05278143?titles=AI+for+Glycemic+Events+Detection+Via+ECG+in+a+Pediatric+Population&draw=2&rank=1.
Supplementary information: The online version contains supplementary material available at 10.1007/s12553-022-00719-x.
期刊介绍：
Health and Technology is the first truly cross-disciplinary journal on issues related to health technologies addressing all professions relating to health, care and health technology.The journal constitutes an information platform connecting medical technology and informatics with the needs of care, health care professionals and patients. Thus, medical physicists and biomedical/clinical engineers are encouraged to write articles not only for their colleagues, but directed to all other groups of readers as well, and vice versa.By its nature, the journal presents and discusses hot subjects including but not limited to patient safety, patient empowerment, disease surveillance and management, e-health and issues concerning data security, privacy, reliability and management, data mining and knowledge exchange as well as health prevention. The journal also addresses the medical, financial, social, educational and safety aspects of health technologies as well as health technology assessment and management, including issues such security, efficacy, cost in comparison to the benefit, as well as social, legal and ethical implications.This journal is a communicative source for the health work force (physicians, nurses, medical physicists, clinical engineers, biomedical engineers, hospital engineers, etc.), the ministries of health, hospital management, self-employed doctors, health care providers and regulatory agencies, the medical technology industry, patients'' associations, universities (biomedical and clinical engineering, medical physics, medical informatics, biology, medicine and public health as well as health economics programs), research institutes and professional, scientific and technical organizations.Health and Technology is jointly published by Springer and the IUPESM (International Union for Physical and Engineering Sciences in Medicine) in cooperation with the World Health Organization.
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