Article Dans Une Revue PLoS ONE Année : 2023

Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study

Résumé

BACKGROUND: We assessed the performance and patient satisfaction of a new insulin patch pump, the A7+TouchCare (Medtrum), compared with the Omnipod system. METHODS: This multicenter, randomized, open-label, controlled study enrolled 100 adult patients with type 1 or type 2 diabetes mellitus (A1C ≥ 6.5% and ≤ 9.5%, i.e., 48 to 80 mmol/mol) who were assigned with the Omnipod or with the A7+TouchCare pump for 3 months. The primary study outcome was the glucose management indicator (GMI) calculated with continuous glucose monitoring (CGM). RESULTS: Premature withdrawals occurs respectively in 2 and 9 participants in the Omnipod and TouchCare groups. In the Per Protocol analysis, the difference in GMI between groups was 0.002% (95% confidence interval -0.251; 0.255). The non-inferiority was demonstrated since the difference between treatments did not overlap the pre-defined non-inferiority margin (0.4%). There was no significant difference in CGM parameters between groups. On average, patients in both groups were satisfied/very satisfied with the insulin pump system. Patients preferred Omnipod as an insulin management system and especially the patch delivery system but preferred the A7+TouchCare personal diabetes manager to control the system. CONCLUSIONS: This study showed that the A7+TouchCare insulin pump was as efficient as the Omnipod pump in terms of performance and satisfaction. CLINICAL TRAIL REGISTRATION: The study was registered in the ClinicalTrials.gov protocol register (NCT04223973).
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Dates et versions

inserm-04432142 , version 1 (01-02-2024)

Identifiants

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C. Amadou, V. Melki, J. Allain, S. Clavel, D. Gouet, et al.. Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study. PLoS ONE, 2023, 18 (8), pp.e0289684. ⟨10.1371/journal.pone.0289684⟩. ⟨inserm-04432142⟩
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