In:
PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 8 ( 2023-8-24), p. e0289684-
Abstract:
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 ).
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0289684
DOI:
10.1371/journal.pone.0289684.g001
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10.1371/journal.pone.0289684.t001
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10.1371/journal.pone.0289684.t002
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10.1371/journal.pone.0289684.t003
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10.1371/journal.pone.0289684.t004
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10.1371/journal.pone.0289684.t005
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10.1371/journal.pone.0289684.s001
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10.1371/journal.pone.0289684.s002
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10.1371/journal.pone.0289684.s003
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10.1371/journal.pone.0289684.s004
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10.1371/journal.pone.0289684.s005
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10.1371/journal.pone.0289684.s006
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10.1371/journal.pone.0289684.r001
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10.1371/journal.pone.0289684.r002
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10.1371/journal.pone.0289684.r003
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10.1371/journal.pone.0289684.r004
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10.1371/journal.pone.0289684.r005
DOI:
10.1371/journal.pone.0289684.r006
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2267670-3
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