Timm Roos, Norbert Hermanns, Christopher Groß, Bernhard Kulzer, Thomas Haak, Dominic Ehrmann
{"title":"胰岛素自动给药系统对糖尿病患者个人报告结果的影响:系统综述和荟萃分析。","authors":"Timm Roos, Norbert Hermanns, Christopher Groß, Bernhard Kulzer, Thomas Haak, Dominic Ehrmann","doi":"10.1016/j.eclinm.2024.102852","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Conclusive evidence on the benefits of automated insulin delivery (AID) systems on person-reported outcomes (PROs) is missing.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, four databases (PubMed, PsycINFO, Cochrane, and GoogleScholar) were searched from inception up to August 7th, 2024. All types of studies were included if studies reported on PROs in people with diabetes using an AID system. All types of control groups in randomised controlled trials (RCT) were included. Summary data were extracted by three reviewers. Main outcomes focused on diabetes distress, fear of hypoglycaemia and quality of life. Meta-analyses were conducted for RCTs and observational studies separately. When five or more studies could be pooled, random-effects meta-analysis was used, otherwise common-effects meta-analysis was used. Risk of bias was evaluated with Cochrane tools. This study was registered with PROSPERO, CRD42022352502.</p><p><strong>Findings: </strong>A total of 62 studies (n = 9253) were included reporting on 45 different questionnaires. Twenty-seven studies were RCTs and 25 were observational studies. RCT meta-analyses showed reduced diabetes distress (standardised mean difference [95% CI]: -0.159 [-0.309, -0.010], I<sup>2</sup> = 23.0%), reduced fear of hypoglycaemia (-0.339 [-0.566, -0.111], I<sup>2</sup> = 42.6%), and improved hypoglycaemia unawareness (-0.231 [-0.424, -0.037], I<sup>2</sup> = 0.0%), quality of life in adults (0.347 [0.134, 0.560], I<sup>2</sup> = 0.0%) and children/adolescents (0.249 [0.050, 0.448], I<sup>2</sup> = 0.0%). Observational meta-analyses corroborated improvements in diabetes distress (-0.217 [-0.403, -0.031], I<sup>2</sup> = 68.5%), fear of hypoglycaemia (-0.445 [-0.540, -0.349], I<sup>2</sup> = 0.0%), hypoglycaemia unawareness (-0.212 [-0.419, -0.004], I<sup>2</sup> = 0.0%), and showed improved sleep quality (-0.158 [-0.255, -0.061], I<sup>2</sup> = 0.0%).</p><p><strong>Interpretation: </strong>We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes. Evidence comes from both RCTs and observational studies. However, for some PROs only a limited number of studies could be pooled with a large heterogeneity in questionnaires used. More research is needed with a more uniformed assessment of PROs to demonstrate the added value of AID therapy on psychosocial outcomes.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"76 ","pages":"102852"},"PeriodicalIF":9.6000,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447321/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of automated insulin delivery systems on person-reported outcomes in people with diabetes: a systematic review and meta-analysis.\",\"authors\":\"Timm Roos, Norbert Hermanns, Christopher Groß, Bernhard Kulzer, Thomas Haak, Dominic Ehrmann\",\"doi\":\"10.1016/j.eclinm.2024.102852\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Conclusive evidence on the benefits of automated insulin delivery (AID) systems on person-reported outcomes (PROs) is missing.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, four databases (PubMed, PsycINFO, Cochrane, and GoogleScholar) were searched from inception up to August 7th, 2024. All types of studies were included if studies reported on PROs in people with diabetes using an AID system. All types of control groups in randomised controlled trials (RCT) were included. Summary data were extracted by three reviewers. Main outcomes focused on diabetes distress, fear of hypoglycaemia and quality of life. Meta-analyses were conducted for RCTs and observational studies separately. When five or more studies could be pooled, random-effects meta-analysis was used, otherwise common-effects meta-analysis was used. Risk of bias was evaluated with Cochrane tools. This study was registered with PROSPERO, CRD42022352502.</p><p><strong>Findings: </strong>A total of 62 studies (n = 9253) were included reporting on 45 different questionnaires. Twenty-seven studies were RCTs and 25 were observational studies. RCT meta-analyses showed reduced diabetes distress (standardised mean difference [95% CI]: -0.159 [-0.309, -0.010], I<sup>2</sup> = 23.0%), reduced fear of hypoglycaemia (-0.339 [-0.566, -0.111], I<sup>2</sup> = 42.6%), and improved hypoglycaemia unawareness (-0.231 [-0.424, -0.037], I<sup>2</sup> = 0.0%), quality of life in adults (0.347 [0.134, 0.560], I<sup>2</sup> = 0.0%) and children/adolescents (0.249 [0.050, 0.448], I<sup>2</sup> = 0.0%). Observational meta-analyses corroborated improvements in diabetes distress (-0.217 [-0.403, -0.031], I<sup>2</sup> = 68.5%), fear of hypoglycaemia (-0.445 [-0.540, -0.349], I<sup>2</sup> = 0.0%), hypoglycaemia unawareness (-0.212 [-0.419, -0.004], I<sup>2</sup> = 0.0%), and showed improved sleep quality (-0.158 [-0.255, -0.061], I<sup>2</sup> = 0.0%).</p><p><strong>Interpretation: </strong>We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes. Evidence comes from both RCTs and observational studies. However, for some PROs only a limited number of studies could be pooled with a large heterogeneity in questionnaires used. More research is needed with a more uniformed assessment of PROs to demonstrate the added value of AID therapy on psychosocial outcomes.</p><p><strong>Funding: </strong>None.</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"76 \",\"pages\":\"102852\"},\"PeriodicalIF\":9.6000,\"publicationDate\":\"2024-09-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447321/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2024.102852\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2024.102852","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Effect of automated insulin delivery systems on person-reported outcomes in people with diabetes: a systematic review and meta-analysis.
Background: Conclusive evidence on the benefits of automated insulin delivery (AID) systems on person-reported outcomes (PROs) is missing.
Methods: In this systematic review and meta-analysis, four databases (PubMed, PsycINFO, Cochrane, and GoogleScholar) were searched from inception up to August 7th, 2024. All types of studies were included if studies reported on PROs in people with diabetes using an AID system. All types of control groups in randomised controlled trials (RCT) were included. Summary data were extracted by three reviewers. Main outcomes focused on diabetes distress, fear of hypoglycaemia and quality of life. Meta-analyses were conducted for RCTs and observational studies separately. When five or more studies could be pooled, random-effects meta-analysis was used, otherwise common-effects meta-analysis was used. Risk of bias was evaluated with Cochrane tools. This study was registered with PROSPERO, CRD42022352502.
Findings: A total of 62 studies (n = 9253) were included reporting on 45 different questionnaires. Twenty-seven studies were RCTs and 25 were observational studies. RCT meta-analyses showed reduced diabetes distress (standardised mean difference [95% CI]: -0.159 [-0.309, -0.010], I2 = 23.0%), reduced fear of hypoglycaemia (-0.339 [-0.566, -0.111], I2 = 42.6%), and improved hypoglycaemia unawareness (-0.231 [-0.424, -0.037], I2 = 0.0%), quality of life in adults (0.347 [0.134, 0.560], I2 = 0.0%) and children/adolescents (0.249 [0.050, 0.448], I2 = 0.0%). Observational meta-analyses corroborated improvements in diabetes distress (-0.217 [-0.403, -0.031], I2 = 68.5%), fear of hypoglycaemia (-0.445 [-0.540, -0.349], I2 = 0.0%), hypoglycaemia unawareness (-0.212 [-0.419, -0.004], I2 = 0.0%), and showed improved sleep quality (-0.158 [-0.255, -0.061], I2 = 0.0%).
Interpretation: We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes. Evidence comes from both RCTs and observational studies. However, for some PROs only a limited number of studies could be pooled with a large heterogeneity in questionnaires used. More research is needed with a more uniformed assessment of PROs to demonstrate the added value of AID therapy on psychosocial outcomes.
期刊介绍:
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.