Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 14, 2022
Open Peer Review Period: Oct 14, 2022 - Oct 14, 2022
Date Accepted: Dec 13, 2022
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Improvement of selected psychological parameters and quality of life in patients with T1DM undergoing transition from MDI and SMBG treatment directly to MiniMed™ 780G AHCL system: Post hoc analyses of Randomized Control Study
ABSTRACT
Background:
While introducing new technologies and methods of treatment of T1DM it seems essential to monitor whether modern technologies in diabetes treatment may improve the psychological, emotional status of the patients.
Objective:
To assess the baseline psychological parameters of the T1DM patients included into the study of the direct transition from Multiple Daily Injections (MDI) and Self-Monitoring of Blood Glucose (BGM) to the MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) and to evaluate changes in the psychological well-being and quality of life after the transition in these individuals versus control group.
Methods:
The trial was a two-center, randomized controlled, parallel group study. 41 T1DM patients managed with MDI/BGM were enrolled and randomized either to AHCL or MDI/BGM groups. 37 participants (age 40.3±8.0 years; duration of diabetes 17.3 ± 12.1 years; HbA1c 7.2 ± 1.0%) completed the study (20 in AHCL and 17 in the MDI/BGM groups). Psychological parameters (the level of stress, coping mechanisms, level of anxiety, self-efficacy level, acceptance of illness, locus of control of the illness, life satisfaction, quality of life) were measured at baseline and at the end of the study using 10 psychological questionnaires.
Results:
Study participants’ general level of stress was higher than in general population (p=0.001), their coping strategies were significantly more effective and they had significantly higher level of self-efficacy (p<0.001). Participants accept more their illness than patients with diabetes from general population (p<0.001) but they feel their health does not depend on them as much as in general population (p<0.001). The overall life satisfaction was similar to general population (p=0.161) The AHCL group reported an increase in their QoL in 4 scales: Feeling well (p=0.042); Working (p=0.012); Eating as I would like (p=0.011); Doing normal things p=0.0343). The level of anxiety decreased in AHCL group STAI1 scores (p=0.009), STAI 1 stens (p=0.013); STAI 2 scores (p=0.022). The AHCL group became more emotion-oriented when in stressful situation CISS E (0.043) and significantly less tend to self-blame after three months of the study (p=0.020).
Conclusions:
The results indicate that transitioning from MDI/BGM treatment to AHCL in patients naïve to technology may significantly improve psychological well-being and quality of life of the patients within 3 months. The rapidity of these changes suggests that they may be related to the significant improvement in glycemic outcomes.
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