Trial reportActa diabetologica2024
Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications.
Trial report in Acta diabetologica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04060732 (Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life.
methodsFour hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events.
results82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35-16.85) in group A and 10.14 (95% CI: 4.08-20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life.
conclusionThis study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals.
trial registrationClinicalTrials.gov registration no. NCT04060732.
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