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Clinical Trial Summary

The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes. Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability. Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.


Clinical Trial Description

This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires. Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months. The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events. The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires. Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04939766
Study type Interventional
Source VitalAire
Contact Emmanuelle MORRY
Phone 0149694515
Email emmanuelle.morry@vitalaire.fr
Status Not yet recruiting
Phase N/A
Start date June 2021
Completion date December 2022

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