Improvement of Selected Psychological Parameters and Quality of Life of Patients With Type 1 Diabetes Mellitus Undergoing Transition From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to the MiniMed 780G Advanced Hybrid Closed-Loop System: Post hoc Analysis of a Randomized Control Study

Abstract

Background 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. Objective 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. Methods 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 A1c [HbA1c] 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. Results 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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT04616391; https://clinicaltrials.gov/ct2/show/NCT04616391

Twelve‐month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed‐loop therapy outcomes versus conventional therapy in adults with type 1 diabetes

“…9 This adds to the growing evidence that beginning diabetes treatment with an AID system, switching from either MDI or previous generations of pump therapies, is not prohibitively burdensome and provides improvements to the user's daily experience with diabetes. [26][27][28] Patient satisfaction with the system was also reflected in the attrition rates, which mimicked those seen in the study phase. Of the 41 participants randomized to receive AID, five dropped out during the study phase (12% attrition).…”

Quality of life in the course of a one-year use of an advanced hybrid closed-loop system in adults with type 1 diabetes previously naïve to advanced diabetes technology

“…The patients filled out a set of questionnaires at the beginning, after 3 months ( 16 ), and after 12 months of the study. After the 3 months stage, the control group ended, and the patients from the studied group continued for an observational period of 9 months.…”

“…The trait anxiety scale assesses the tendency of the patient to react with apprehension and worry in general, and anxiety measured here is understood as a trait of personality. Each subscale consists of 20 items ( 16 , 18 ). Response for X1 assesses the intensity of current feelings evaluated by answering 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so.…”

“…Recently we published a randomized control study in which we indicated that a population of patients with T1D previously naïve to advanced technology, who decided to undergo transition from multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG) directly to the MiniMed 780G™ AHCL, experienced a significant improvement in selected aspects of quality of life: feeling well, working, eating as I would like, and doing normal things in as short time as 3 months after the transition. In addition, the patients from the AHCL group experienced lower levels of stress, fewer feelings of guilt, and could more easily be in contact with their emotions in stressful situations ( 16 , 17 ). It was the first such study investigating psychological parameters in a population that has undergone the most extreme transformation from naïve to technology to advanced hybrid closed-loop therapy.…”

Automated Insulin Delivery (AID) Systems: Use and Efficacy in Children and Adults with Type 1 Diabetes and Other Forms of Diabetes in Europe in Early 2023

“…A large retrospective study involving more than 4000 Minimed 780G users demonstrated that they achieved a mean GMI of 6.8% and a mean TIR of 76.2% after initiating AHCL, while minimizing hypoglycemia [ 22 ]. The real-world use of Minimed 780G also provides an increased level of patient satisfaction [ 23 , 24 ].…”