在 1 型糖尿病患者中开展的一项随机对照临床试验:比较传统面对面访问与远程医疗和面对面随访混合方法对近期先进闭环系统用户的生活质量的影响。

IF 3.9 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Therapeutic Advances in Endocrinology and Metabolism Pub Date : 2024-10-25 eCollection Date: 2024-01-01 DOI:10.1177/20420188241288789
Lía Nattero-Chávez, Esther de La Calle, Edurne Lecumberri-Pascual, Ane Bayona Cebada, Teresa Ruiz Gracia, Alejandra Quintero Tobar, Mar Lorenzo Moñino, Cristina Sánchez Rodríguez, Ana Izquierdo, Héctor F Escobar-Morreale, Manuel Luque-Ramírez
{"title":"在 1 型糖尿病患者中开展的一项随机对照临床试验:比较传统面对面访问与远程医疗和面对面随访混合方法对近期先进闭环系统用户的生活质量的影响。","authors":"Lía Nattero-Chávez, Esther de La Calle, Edurne Lecumberri-Pascual, Ane Bayona Cebada, Teresa Ruiz Gracia, Alejandra Quintero Tobar, Mar Lorenzo Moñino, Cristina Sánchez Rodríguez, Ana Izquierdo, Héctor F Escobar-Morreale, Manuel Luque-Ramírez","doi":"10.1177/20420188241288789","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Our objective was to assess the effect of a hybrid telemedicine approach, in conjunction with face-to-face follow-up, on the quality of life in recent users of an advanced hybrid closed-loop (AHCL) system.</p><p><strong>Methods: </strong>A 1-year open randomized (1:1) clinical trial (ClinicalTrials.gov ID NCT04900636). Participants with type 1 diabetes (T1D) recent users of an AHCL system (Minimed<sup>®</sup> 780G) for at least 2-6 months, and ⩾18 years old were eligible. The primary outcome was the change in quality of life measured by the Type 1 Diabetes Life (ViDa1) Questionnaire from baseline to 12 months of hybrid telemedicine plus face-to-face follow-up compared to standard clinical practice. Additionally, impacts on A<sub>1c</sub> levels, glucose metrics, advert events, and safety outcomes were assessed.</p><p><strong>Results: </strong>Between January and December 2021, 46 participants were randomly assigned in a 1:1 ratio to either the hybrid telemedicine group (<i>n</i> = 23) or the control group (<i>n</i> = 23); 45 participants completed the study, with only 1 from the control group withdrawing before visit 3. At baseline, mean age was 37 ± 15 years and A<sub>1c</sub> was 6.9 ± 0.5%. After 12 months, no statistically significant differences in ViDa1 scores between groups were observed. Despite reducing in-person visits in the hybrid follow-up arm, there were no increases in adverse events. Overall, A<sub>1c</sub> levels significantly decreased from 6.9 ± 0.5% at baseline to 6.7 ± 0.5% after 12 months (<i>P</i> = 0.006) without differences between treatment arms, accompanied by reductions in glycemic variability and time below the target range.</p><p><strong>Conclusion: </strong>Our study suggests that there were no significant differences in ViDa1 scores between the two groups at the end of the follow-up. However, among adult patients with T1D who recently adopted an AHCL system, satisfactory glycemic control can be attained through a hybrid follow-up approach, reducing face-to-face visits, without increasing technical complications.</p>","PeriodicalId":22998,"journal":{"name":"Therapeutic Advances in Endocrinology and Metabolism","volume":"15 ","pages":"20420188241288789"},"PeriodicalIF":3.9000,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528595/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes.\",\"authors\":\"Lía Nattero-Chávez, Esther de La Calle, Edurne Lecumberri-Pascual, Ane Bayona Cebada, Teresa Ruiz Gracia, Alejandra Quintero Tobar, Mar Lorenzo Moñino, Cristina Sánchez Rodríguez, Ana Izquierdo, Héctor F Escobar-Morreale, Manuel Luque-Ramírez\",\"doi\":\"10.1177/20420188241288789\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Our objective was to assess the effect of a hybrid telemedicine approach, in conjunction with face-to-face follow-up, on the quality of life in recent users of an advanced hybrid closed-loop (AHCL) system.</p><p><strong>Methods: </strong>A 1-year open randomized (1:1) clinical trial (ClinicalTrials.gov ID NCT04900636). Participants with type 1 diabetes (T1D) recent users of an AHCL system (Minimed<sup>®</sup> 780G) for at least 2-6 months, and ⩾18 years old were eligible. The primary outcome was the change in quality of life measured by the Type 1 Diabetes Life (ViDa1) Questionnaire from baseline to 12 months of hybrid telemedicine plus face-to-face follow-up compared to standard clinical practice. Additionally, impacts on A<sub>1c</sub> levels, glucose metrics, advert events, and safety outcomes were assessed.</p><p><strong>Results: </strong>Between January and December 2021, 46 participants were randomly assigned in a 1:1 ratio to either the hybrid telemedicine group (<i>n</i> = 23) or the control group (<i>n</i> = 23); 45 participants completed the study, with only 1 from the control group withdrawing before visit 3. At baseline, mean age was 37 ± 15 years and A<sub>1c</sub> was 6.9 ± 0.5%. After 12 months, no statistically significant differences in ViDa1 scores between groups were observed. Despite reducing in-person visits in the hybrid follow-up arm, there were no increases in adverse events. Overall, A<sub>1c</sub> levels significantly decreased from 6.9 ± 0.5% at baseline to 6.7 ± 0.5% after 12 months (<i>P</i> = 0.006) without differences between treatment arms, accompanied by reductions in glycemic variability and time below the target range.</p><p><strong>Conclusion: </strong>Our study suggests that there were no significant differences in ViDa1 scores between the two groups at the end of the follow-up. However, among adult patients with T1D who recently adopted an AHCL system, satisfactory glycemic control can be attained through a hybrid follow-up approach, reducing face-to-face visits, without increasing technical complications.</p>\",\"PeriodicalId\":22998,\"journal\":{\"name\":\"Therapeutic Advances in Endocrinology and Metabolism\",\"volume\":\"15 \",\"pages\":\"20420188241288789\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-10-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528595/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Endocrinology and Metabolism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/20420188241288789\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Endocrinology and Metabolism","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420188241288789","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0

摘要

背景:我们的目的是评估混合远程医疗方法与面对面随访相结合对先进混合闭环(AHCL)系统近期用户生活质量的影响:为期 1 年的开放式随机(1:1)临床试验(ClinicalTrials.gov ID NCT04900636)。参与者均为 1 型糖尿病(T1D)患者,最近使用 AHCL 系统(Minimed® 780G)至少 2-6 个月,年龄在 18 岁以下。与标准临床实践相比,主要结果是通过 1 型糖尿病生活 (ViDa1) 问卷测量从基线到 12 个月混合远程医疗加面对面随访期间生活质量的变化。此外,还评估了对 A1c 水平、血糖指标、广告事件和安全结果的影响:2021 年 1 月至 12 月,46 名参与者按 1:1 的比例被随机分配到混合远程医疗组(23 人)或对照组(23 人);45 名参与者完成了研究,对照组只有 1 人在第 3 次就诊前退出。基线平均年龄为 37 ± 15 岁,A1c 为 6.9 ± 0.5%。12 个月后,观察到各组之间的 ViDa1 评分差异无统计学意义。尽管混合随访组的面访次数减少,但不良事件并未增加。总体而言,A1c 水平从基线时的 6.9 ± 0.5% 显著降至 12 个月后的 6.7 ± 0.5%(P = 0.006),治疗组之间无差异,同时血糖变异性和低于目标范围的时间也有所减少:我们的研究表明,在随访结束时,两组患者的 ViDa1 评分没有明显差异。然而,在最近采用 AHCL 系统的 T1D 成年患者中,可以通过混合随访方法达到满意的血糖控制效果,减少面对面的就诊次数,同时不会增加技术并发症。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes.

Background: Our objective was to assess the effect of a hybrid telemedicine approach, in conjunction with face-to-face follow-up, on the quality of life in recent users of an advanced hybrid closed-loop (AHCL) system.

Methods: A 1-year open randomized (1:1) clinical trial (ClinicalTrials.gov ID NCT04900636). Participants with type 1 diabetes (T1D) recent users of an AHCL system (Minimed® 780G) for at least 2-6 months, and ⩾18 years old were eligible. The primary outcome was the change in quality of life measured by the Type 1 Diabetes Life (ViDa1) Questionnaire from baseline to 12 months of hybrid telemedicine plus face-to-face follow-up compared to standard clinical practice. Additionally, impacts on A1c levels, glucose metrics, advert events, and safety outcomes were assessed.

Results: Between January and December 2021, 46 participants were randomly assigned in a 1:1 ratio to either the hybrid telemedicine group (n = 23) or the control group (n = 23); 45 participants completed the study, with only 1 from the control group withdrawing before visit 3. At baseline, mean age was 37 ± 15 years and A1c was 6.9 ± 0.5%. After 12 months, no statistically significant differences in ViDa1 scores between groups were observed. Despite reducing in-person visits in the hybrid follow-up arm, there were no increases in adverse events. Overall, A1c levels significantly decreased from 6.9 ± 0.5% at baseline to 6.7 ± 0.5% after 12 months (P = 0.006) without differences between treatment arms, accompanied by reductions in glycemic variability and time below the target range.

Conclusion: Our study suggests that there were no significant differences in ViDa1 scores between the two groups at the end of the follow-up. However, among adult patients with T1D who recently adopted an AHCL system, satisfactory glycemic control can be attained through a hybrid follow-up approach, reducing face-to-face visits, without increasing technical complications.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Therapeutic Advances in Endocrinology and Metabolism
Therapeutic Advances in Endocrinology and Metabolism Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
7.70
自引率
2.60%
发文量
42
审稿时长
8 weeks
期刊介绍: Therapeutic Advances in Endocrinology and Metabolism delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of endocrinology and metabolism.
期刊最新文献
Comparing the efficacy and safety of weekly somatrogon with daily somatropin to treat children with growth hormone deficiency: a plain language summary of publication. Understanding the burden of weekly somatrogon injections compared with daily somatropin injections in children with growth hormone deficiency: a plain language summary of publication. Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes. Measurement of salivary thyroid hormones using the LC-MS/MS technique in a clinical setting. Excessive or sustained endoplasmic reticulum stress: one of the culprits of adipocyte dysfunction in obesity.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1