Yongwen Zhou, Mengyun Lei, Daizhi Yang, Ping Ling, Ying Ni, Hongrong Deng, Wen Xu, Xubin Yang, Benjamin John Wheeler, Jianping Weng, Jinhua Yan
{"title":"1 型糖尿病患者使用开源自动胰岛素给药的实际效果和安全性：中国大陆的经验。","authors":"Yongwen Zhou, Mengyun Lei, Daizhi Yang, Ping Ling, Ying Ni, Hongrong Deng, Wen Xu, Xubin Yang, Benjamin John Wheeler, Jianping Weng, Jinhua Yan","doi":"10.1016/j.diabres.2024.111910","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Open-source automated insulin delivery systems are increasingly adopted yet predominantly discussed outside of Asia. This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China.</p><p><strong>Methods: </strong>This real-world study recruited people who initiated AAPS for ≥ 3 months between 2019 and 2024. Key outcomes included glycated hemoglobin A1c (HbA1c) and metrics from continuous glucose monitoring, rates of diabetic ketoacidosis (DKA) and severe hypoglycemia.</p><p><strong>Findings: </strong>292 (male, 46·9 %) participants aged 25·7 (14·7, 35·0) years were included, with 183 (62·7 %) and 68 (23·3 %) using AAPS for 6 and 12 months. Prior-AAPS HbA1c was 7·6 ± 1·7 % with 44·5 % achieving < 7·0 %. After 3 months, mean HbA1c improved by -1·5 ± 2·0 % to 6·3 ± 0·8 % (P < 0.01), with 82·9 % achieving < 7.0 %. Time in range 3·9-10·0 mmol/L (TIR) improved to 78·8 ± 12·9 %, with 80·5 % achieving > 70 %, followed by time below 3·9 mmol/L of 3·9 (2·1, 6·1) %. After 12 months, HbA1c and TIR remained similar at 6·4 ± 1·0 % and 77·9 ± 12·2 %. No DKA and severe hypoglycemia was observed.</p><p><strong>Interpretation: </strong>Real-world data from mainland China highlights current uptake of open-source AAPS with potential glycemic benefits. No safety signals are seen. More support to enhance access and utilization of all AID systems in this region is warranted.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111910"},"PeriodicalIF":6.1000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world efficacy and safety of open-source automated insulin delivery for people with type 1 diabetes mellitus: Experience from mainland China.\",\"authors\":\"Yongwen Zhou, Mengyun Lei, Daizhi Yang, Ping Ling, Ying Ni, Hongrong Deng, Wen Xu, Xubin Yang, Benjamin John Wheeler, Jianping Weng, Jinhua Yan\",\"doi\":\"10.1016/j.diabres.2024.111910\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Open-source automated insulin delivery systems are increasingly adopted yet predominantly discussed outside of Asia. This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China.</p><p><strong>Methods: </strong>This real-world study recruited people who initiated AAPS for ≥ 3 months between 2019 and 2024. Key outcomes included glycated hemoglobin A1c (HbA1c) and metrics from continuous glucose monitoring, rates of diabetic ketoacidosis (DKA) and severe hypoglycemia.</p><p><strong>Findings: </strong>292 (male, 46·9 %) participants aged 25·7 (14·7, 35·0) years were included, with 183 (62·7 %) and 68 (23·3 %) using AAPS for 6 and 12 months. Prior-AAPS HbA1c was 7·6 ± 1·7 % with 44·5 % achieving < 7·0 %. After 3 months, mean HbA1c improved by -1·5 ± 2·0 % to 6·3 ± 0·8 % (P < 0.01), with 82·9 % achieving < 7.0 %. Time in range 3·9-10·0 mmol/L (TIR) improved to 78·8 ± 12·9 %, with 80·5 % achieving > 70 %, followed by time below 3·9 mmol/L of 3·9 (2·1, 6·1) %. After 12 months, HbA1c and TIR remained similar at 6·4 ± 1·0 % and 77·9 ± 12·2 %. No DKA and severe hypoglycemia was observed.</p><p><strong>Interpretation: </strong>Real-world data from mainland China highlights current uptake of open-source AAPS with potential glycemic benefits. No safety signals are seen. More support to enhance access and utilization of all AID systems in this region is warranted.</p>\",\"PeriodicalId\":11249,\"journal\":{\"name\":\"Diabetes research and clinical practice\",\"volume\":\" \",\"pages\":\"111910\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-10-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes research and clinical practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.diabres.2024.111910\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes research and clinical practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.diabres.2024.111910","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Real-world efficacy and safety of open-source automated insulin delivery for people with type 1 diabetes mellitus: Experience from mainland China.
Background: Open-source automated insulin delivery systems are increasingly adopted yet predominantly discussed outside of Asia. This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China.
Methods: This real-world study recruited people who initiated AAPS for ≥ 3 months between 2019 and 2024. Key outcomes included glycated hemoglobin A1c (HbA1c) and metrics from continuous glucose monitoring, rates of diabetic ketoacidosis (DKA) and severe hypoglycemia.
Findings: 292 (male, 46·9 %) participants aged 25·7 (14·7, 35·0) years were included, with 183 (62·7 %) and 68 (23·3 %) using AAPS for 6 and 12 months. Prior-AAPS HbA1c was 7·6 ± 1·7 % with 44·5 % achieving < 7·0 %. After 3 months, mean HbA1c improved by -1·5 ± 2·0 % to 6·3 ± 0·8 % (P < 0.01), with 82·9 % achieving < 7.0 %. Time in range 3·9-10·0 mmol/L (TIR) improved to 78·8 ± 12·9 %, with 80·5 % achieving > 70 %, followed by time below 3·9 mmol/L of 3·9 (2·1, 6·1) %. After 12 months, HbA1c and TIR remained similar at 6·4 ± 1·0 % and 77·9 ± 12·2 %. No DKA and severe hypoglycemia was observed.
Interpretation: Real-world data from mainland China highlights current uptake of open-source AAPS with potential glycemic benefits. No safety signals are seen. More support to enhance access and utilization of all AID systems in this region is warranted.
期刊介绍：
Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.
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