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Master Thesis

Analyse de la satisfaction et de l’usabilité du traitement par la boucle fermée Diabeloop DBLHU chez les patients atteints de diabète de type 1 très instable sur leur satisfaction a 4 mois de traitement

Abstract : Background: Closed-loop (CL) systems are promising treatments for patients with highly unstable diabetes (HUD). Our objective was to assess whether the Diabeloop for Highly Unstable Type 1 Diabetes (DBLHU) CL hybrid system could improve treatment satisfaction in patients with HUD compared to a predictive low glucose suspend system (PLGS). Method: The analysis studied data from the prospective DBLHU-WP10 trial testing DBLHU in 7 adults with HUD with severe hypoglycemia (SH), theoretically candidates for islet transplantation. After a two-week run-in period, patients were randomized to a series of N-of-1 trials. The primary outcome assessed patients satisfaction with DBLHU compared to PLGS using Diabetes Treatment Satisfaction Questionnaire (DTSQ) administered at initial and final visits. The DBLHU usability, analyzing the human factor (HF), was assessed through a global usability questionnaire (GUQ) administered at the final visit. Results: Using DBLHU was associated with a significant increase in the treatment satisfaction score (48.0 (9.6)) compared to PLGS (38.6 (6.1)) (9.4 (95%, CI 3.6-15.2) (p=0.0313)). The perceived frequency score of hypoglycemia was significantly lower using DBLHU (1.7 (0.8)) compared to PLGS (3.7 (1.1)) (-2.0 (95% CI -2.9; -1.1) (p=0.0156)). The GUQ demonstrated a high perceived ease and autonomy of use with DBLHU system. Finally, all patients wished to continue with DBLHU system at the end of the study, which was achieved thanks to an extension phase, until the DBLHU system will be covered by health insurance. Conclusion: This study suggests a better satisfaction of patients with HUD using DBLHU system compared to PLGS. These data deserve confirmation with specifically-designed questionnaires, adapted to CL devices, addressing HF, including satisfaction, quality of life and usability.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02951416
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Submitted on : Monday, September 28, 2020 - 4:28:38 PM
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Johanna Delagenière. Analyse de la satisfaction et de l’usabilité du traitement par la boucle fermée Diabeloop DBLHU chez les patients atteints de diabète de type 1 très instable sur leur satisfaction a 4 mois de traitement. Médecine humaine et pathologie. 2020. ⟨dumas-02951416⟩

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