A new glucose monitoring system for the intermittent monitoring of interstitial glucose values in patients with diabetes mellitus.

Abstract

Objectives: Glucose monitoring in diabetes is changing overtime with a constant development of new devices for continuous glucose monitoring (CGM). Aim of this observational, prospective study was to evaluate the clinical performance of a novel intermittently scanned CGM system, the Glunovo Flash in a cohort of patients with type 1 diabetes.

Methods: A total of 45 patients with T1D followed at the Endocrinology Unit of the ASST-FBF-Sacco (Milan) were enrolled. All patients were habitual CGM users and were asked to wear simultaneously the Glunovo Flash system and their habitual CGM device for 14 days. A comparison of CGM glucose metrics was performed. Patients' opinions on the new device were also collected.

Results: Thirty-five patients completed the study period of two weeks (7 habitual real time CGM users, 28 habitual intermittently scanned CGM users). Mean Time In Range resulted significantly higher with the novel studied sensor respect to intermittently scanned CGM comparator. No differences were found considering other glucose metrics. A positive correlation was found between the Time In Range recorded by Glunovo Flash and intermittently scanned CGM comparators as well as for Time Above Range, Glucose Management Indicator, Time Below Range and Coefficient of Variation. No correlations were found between glucose metrics recorded by Glunovo Flash and real time CGM comparators. Patients reported a positive experience of use with the new sensor but some elements appeared improvable.

Conclusions: The CGM device Glunovo Flash for patients with diabetes shows similar performance to other intermittently scanned CGM systems.