Rossi Antonio, Rossi Giada, Montefusco Laura, Cimino Vincenzo, Pastore Ida, Gandolfi Alessandra, Bucciarelli Loredana, Loretelli Cristian, Boci Denisa, D'Addio Francesca, Lunati Maria Elena, Fiorina Paolo
I.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy.
Dept. Biomedical and Clinical Sciences, Università di Milano, Milan, Italy.
J Diabetes Metab Disord. 2024 Sep 9;23(2):2201-2205. doi: 10.1007/s40200-024-01488-2. eCollection 2024 Dec.
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.
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.
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.
The CGM device Glunovo Flash for patients with diabetes shows similar performance to other intermittently scanned CGM systems.
随着持续葡萄糖监测（CGM）新设备的不断发展，糖尿病患者的血糖监测也在与时俱进。本观察性前瞻性研究的目的是评估一种新型间歇性扫描CGM系统Glunovo Flash在1型糖尿病患者队列中的临床性能。
共纳入了45名在米兰ASST - FBF - 萨科内分泌科随访的1型糖尿病患者。所有患者均为CGM的长期使用者，并被要求同时佩戴Glunovo Flash系统及其常用的CGM设备14天。对CGM血糖指标进行了比较。还收集了患者对新设备的意见。
35名患者完成了为期两周的研究期（7名常用实时CGM使用者，28名常用间歇性扫描CGM使用者）。与间歇性扫描CGM对照设备相比，使用新型研究传感器时的平均血糖达标时间显著更高。在考虑其他血糖指标时未发现差异。Glunovo Flash记录的血糖达标时间与间歇性扫描CGM对照设备之间以及高于目标范围时间、血糖管理指标、低于目标范围时间和变异系数之间均发现存在正相关。Glunovo Flash记录的血糖指标与实时CGM对照设备之间未发现相关性。患者报告使用新传感器有积极的体验，但有些方面似乎还有改进的空间。
糖尿病患者使用的CGM设备Glunovo Flash与其他间歇性扫描CGM系统表现相似。
