Numerical and clinical precision in hypoglycemia of the intermittent FreeStyle Libre glucose monitoring through an NFC-Bluetooth transmitter associated with the xDrip+ algorithm in diabetic patients under insulin therapy

Introduction: There are data capture devices that attach to the FreeStyle Libre sensor and convert its communication from NFC (Near-field communication) to Bluetooth technology, generating real-time continuous glucose monitoring. The accuracy of hypoglycemia measurements displayed by smartphone apps using this device has not been established.

Methods: Study of diagnostic tests. Numerical accuracy was evaluated, utilizing the absolute difference with respect to capillary glucometry (ISO 15197:2015 standard) and clinical accuracy, using the Clarke and Parkes (Consensus) error grids, for glucose measurements less than 70mg/dL performed with the FreeStyle Libre system and with the digital estimation xDrip+ app, in diabetic patients managed with insulin therapy.

Results: Twenty-seven patients were included (TIR 73.4%, TBR70 5.6%), who contributed 83 hypoglycemic events. Numerical accuracy was adequate in similar proportions with the FreeStyle Libre system compared to the xDrip+ app (81.92% vs. 68.67%, p=0.0630). The clinical accuracy evaluation showed that 92.8% of the measurements for xDrip+ and 98.8% for FreeStyle libre met the criteria according to the Parkes (Consensus) grid (p=0.0535); and 79.5% and 91.6% of the measurements met the criteria according to the Clarke grid (p=0.0273), being higher with FreeStyle libre.

Conclusions: The use of the NFC-Bluetooth transmitter (Miao-Miao) associated with the xDrip+ app does not improve numerical or clinical accuracy for detecting hypoglycemic events in diabetic patients managed with insulin therapy, compared to the FreeStyle Libre device.