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":null,"pages":null},"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\":null,\"pages\":null},\"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}
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.
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.