Nattero-Chávez Lía, de La Calle Esther, Lecumberri-Pascual Edurne, Bayona Cebada Ane, Ruiz Gracia Teresa, Quintero Tobar Alejandra, Lorenzo Moñino Mar, Sánchez Rodríguez Cristina, Izquierdo Ana, Escobar-Morreale Héctor F, Luque-Ramírez Manuel
Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Carretera de Colmenar, Km 9.1, E-28034 Madrid, Spain.
Grupo de Investigación en Diabetes, Obesidad y Reproducción Humana, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM) & Universidad de Alcalá, Madrid, Spain.
Ther Adv Endocrinol Metab. 2024 Oct 25;15:20420188241288789. doi: 10.1177/20420188241288789. eCollection 2024.
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.
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 A levels, glucose metrics, advert events, and safety outcomes were assessed.
Between January and December 2021, 46 participants were randomly assigned in a 1:1 ratio to either the hybrid telemedicine group ( = 23) or the control group ( = 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 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 levels significantly decreased from 6.9 ± 0.5% at baseline to 6.7 ± 0.5% after 12 months ( = 0.006) without differences between treatment arms, accompanied by reductions in glycemic variability and time below the target range.
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.
我们的目标是评估一种混合远程医疗方法结合面对面随访，对近期使用先进混合闭环（AHCL）系统的患者生活质量的影响。
一项为期1年的开放随机（1:1）临床试验（ClinicalTrials.gov标识符NCT04900636）。1型糖尿病（T1D）患者，近期使用AHCL系统（美敦力780G）至少2 - 6个月，且年龄≥18岁者符合条件。主要结局是通过1型糖尿病生活（ViDa1）问卷测量的生活质量从基线到混合远程医疗加面对面随访12个月时的变化，并与标准临床实践进行比较。此外，评估了对糖化血红蛋白（A1C）水平、血糖指标、不良事件和安全结局的影响。
在2021年1月至12月期间，46名参与者按1:1比例随机分配至混合远程医疗组（n = 23）或对照组（n = 23）；45名参与者完成了研究，对照组仅1名在第3次就诊前退出。基线时，平均年龄为37±15岁，糖化血红蛋白（A1C）为6.9±0.5%。12个月后，两组间ViDa1评分无统计学显著差异。尽管混合随访组减少了面对面就诊次数，但不良事件并未增加。总体而言，糖化血红蛋白（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），各治疗组间无差异，同时血糖变异性和低于目标范围的时间也有所降低。
我们的研究表明，随访结束时两组间ViDa1评分无显著差异。然而，在近期采用AHCL系统的成年T1D患者中，通过混合随访方法可实现令人满意的血糖控制，减少面对面就诊次数，且不增加技术并发症。
