Cyranka Katarzyna, Matejko Bartłomiej, Juza Anna, Kieć-Wilk Beata, Krzyżowska Sabina, Cohen Ohad, Da Silva Julien, Lushchyk Maxim, Malecki Maciej T, Klupa Tomasz
Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland.
Department of Psychiatry, Jagiellonian University Medical College, Krakow, Poland.
JMIR Form Res. 2023 Jan 24;7:e43535. doi: 10.2196/43535.
While introducing new technologies and methods of treatment for type 1 diabetes mellitus (T1DM), it seems essential to monitor whether modern technologies in diabetes treatment may improve the psychological and emotional status of patients.
This study aims to assess the baseline psychological parameters of patients with T1DM during investigation of the direct transition from multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG) to the MiniMed 780G advanced hybrid closed-loop (AHCL) system and to evaluate changes in the psychological well-being and quality of life (QoL) after the transition in these individuals versus the control group.
The trial was a 2-center, randomized controlled, parallel group study. In total, 41 patients with T1DM managed with MDI or SMBG were enrolled and randomized either to the AHCL or the MDI+SMBG group. Of these, 37 (90%) participants (mean age 40.3 years, SD 8.0 years; mean duration of diabetes 17.3, SD 12.1 years; mean hemoglobin A [HbA] 7.2%, SD 1.0%) completed the study (AHCL: n=20, 54%; MDI+SMBG: n=17, 46%). Psychological parameters (level of stress, coping mechanisms, level of anxiety, self-efficacy level, acceptance of illness, locus of control of illness, life satisfaction, QoL) were measured at baseline and at the end of the study using 10 psychological questionnaires.
At baseline, the general level of stress of the examined patients was higher than in the general healthy Polish population (P=.001), but coping strategies used in stressful situations were significantly more effective and the level of self-efficacy (P<.001) was much higher than in the general population. The patients in this study accepted their illness more than patients with diabetes from the general Polish population (P<.001), but they felt that their health does not depend on them compared to the general population (P<.001). The overall life satisfaction was similar to that of the general population (P=.161). After 3 months from transition, the AHCL group reported an increase in 4 scales of the QoL-feeling well (P=.042), working (P=.012), eating as I would like (P=.011), and doing normal things (P=.034)-in comparison to the control group, where no significant change occurred. The level of both state anxiety and trait anxiety decreased in the AHCL group: State-Trait Anxiety Inventory (STAI) X1 scores (P=.009), STAI X1 stens (P=.013), and STAI X2 scores (P=.022). The AHCL group became more emotion oriented in stressful situations (Coping Inventory for Stressful Situations [CISS] E; P=.043) and significantly less self-blaming after 3 months of the study (P=.020).
The results indicate that the patients who decided to take part in the transition study were characterized by higher levels of stress than the general healthy population but had better coping strategies and self-efficacy. Furthermore, transitioning from MDI+SMBG treatment to the AHCL in patients naive to technology may significantly improve psychological well-being and QoL within 3 months. The rapidity of these changes suggests that they may be related to the significant improvement in glycemic outcomes but also significantly less burdened diabetes self-management.
ClinicalTrials.gov NCT04616391; https://clinicaltrials.gov/ct2/show/NCT04616391.
在引入1型糖尿病（T1DM）的新技术和治疗方法时，监测糖尿病治疗中的现代技术是否能改善患者的心理和情绪状态似乎至关重要。
本研究旨在评估T1DM患者在从每日多次注射（MDI）和自我血糖监测（SMBG）直接过渡到美敦力780G高级混合闭环（AHCL）系统的研究过程中的基线心理参数，并评估这些个体与对照组在过渡后心理健康和生活质量（QoL）的变化。
该试验是一项2中心、随机对照、平行组研究。总共招募了41名采用MDI或SMBG治疗的T1DM患者，并将其随机分为AHCL组或MDI + SMBG组。其中，37名（90%）参与者（平均年龄40.3岁，标准差8.0岁；平均糖尿病病程17.3年，标准差12.1年；平均糖化血红蛋白[HbA]7.2%，标准差1.0%）完成了研究（AHCL组：n = 20，54%；MDI + SMBG组：n = 17，46%）。在基线和研究结束时，使用10份心理问卷测量心理参数（压力水平、应对机制、焦虑水平、自我效能水平、疾病接受度、疾病控制点、生活满意度、QoL）。
在基线时，受试患者的总体压力水平高于波兰普通健康人群（P = 0.001），但在压力情况下使用的应对策略明显更有效，自我效能水平（P < 0.001）也远高于普通人群。本研究中的患者比波兰普通糖尿病患者更能接受自己的疾病（P < 0.001），但与普通人群相比，他们觉得自己的健康并不取决于自己（P < 0.001）。总体生活满意度与普通人群相似（P = 0.161）。过渡3个月后，与对照组相比，AHCL组报告在QoL的4个维度上有所改善——感觉良好（P = 0.042）、工作（P = 0.012）、按自己的意愿饮食（P = 0.011）和做正常的事情（P = 0.034），而对照组没有显著变化。AHCL组的状态焦虑和特质焦虑水平均有所下降：状态 - 特质焦虑量表（STAI）X1得分（P = 0.009）、STAI X1标准分（P = 0.013）和STAI X2得分（P = 0.022）。在研究3个月后，AHCL组在压力情况下变得更注重情绪（压力情境应对量表[CISS]E；P = 0.043），且自责明显减少（P = 0.020）。
结果表明，决定参与过渡研究的患者的特点是压力水平高于普通健康人群，但具有更好的应对策略和自我效能。此外，对于不熟悉技术的患者，从MDI + SMBG治疗过渡到AHCL可能在3个月内显著改善心理健康和QoL。这些变化的迅速性表明，它们可能与血糖结果的显著改善以及糖尿病自我管理负担的显著减轻有关。
ClinicalTrials.gov NCT04616391；https://clinicaltrials.gov/ct2/show/NCT04616391。
