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Master Thesis

Évaluation rétrospective de l’efficacité du capteur ENLITE® couplé à la pompe MINIMEDtm 640G chez les patients diabétiques de type 1 équipés au CHU Grenoble-Alpes

Abstract : Context: The decree of February the 13th, 2018 lists the ENLITE® sensor linked to the MINIMED 640G - an external insulin pump - from MEDTRONIC France under the list of refundable products and services laid down by article L. 165-1 of the French Social Security Code. To be eligible for reimbursement of this system, type 1 diabetic patients must have a glycated hemoglobin level (HbA1c) greater than or equal to 8% throughout their last blood test and/or have experienced, during the previous year, at least one severe hypoglycaemia requiring a medical intervention in emergency. Objective: To assess the efficiency of the ENLITE® sensor on glycemic control settings (HbA1c levels and severe hypoglycaemia) in patients with type 1 diabetes meeting the reimbursement criteria. Methods: Retrospective analysis of patients with type 1 diabetes equipped at the Grenoble Alpes University Hospital with the ENLITE® interstitial glucose measurement system linked to the MINIMED 640G insulin pump from February the 13th, 2018. The main outcome was the evolution of HbA1c levels and severe hypoglycaemia episodes between the year before and the year after the ENLITE® sensor was installed. The secondary outcome was the durability of the metabolic effect after two years. Usability, patient satisfaction, their ability to recommend the device and their feedback were also collected. Results: 64 patients with type 1 diabetes (35 women and 29 men, aged 46.9 ± 13.9 years and BMI 26.2 ± 5.3 kg/m2) were included. In this total population and all the subgroups resulting from it, the respective averages of HbA1c levels, before the installation of the ENLITE® sensor — 8.3 ± 1.3% ; 8.5 ± 0.7% ; 9.6 ± 1.2% — were different (p<0.05) from the respective averages of HbA1c levels, after the installation of the ENLITE® sensor — 7.7 ± 0.8% ; 8.0 ± 0.5% ; 8.3 ± 0.6%. Concurrently, the respective means of severe hypoglycaemia, the year preceding the equipment by the sensor — 7.0 ± 20.9 ; 13.3 ± 32.3 ; 8.1 ± 9.7 — were also different (p<0.05) from the respective means of severe hypoglycaemia, the year following the equipment by the sensor — 0.1 ± 0.6 ; 0.1 ± 0.4 ; 0.4 ± 1.0. After two years, no patient has experienced a severe hypoglycaemia. Finally, patients were satisfied and found the device easy to use. Conclusion: The significant decreases in HbA1c levels and in the number of severe hypoglycaemia, in all the relevant populations, one year after the installation of the ENLITE® sensor, highlight its efficiency. Therefore, the registration of the ENLITE® glucose sensor linked to the MINIMED 640G insulin pump under the list of refundable products and services seems justified in patients with type 1 diabetes care meeting the reimbursement criteria.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03084625
Contributor : Jean-Hugues Morneau <>
Submitted on : Monday, December 21, 2020 - 11:38:58 AM
Last modification on : Wednesday, December 23, 2020 - 3:24:11 AM

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Benjamin Amar, Mongi Farhani. Évaluation rétrospective de l’efficacité du capteur ENLITE® couplé à la pompe MINIMEDtm 640G chez les patients diabétiques de type 1 équipés au CHU Grenoble-Alpes. Sciences pharmaceutiques. 2020. ⟨dumas-03084625⟩

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