Clinical interpretation of the flash continuous glucose monitoring data out of range in type 2 diabetes: A real-world study.

AIMS: Flash continuous glucose monitoring system (FCGM) reports nocturnal hypoglycemia with low accuracy in low blood glucose. In our study, we aimed to evaluate the accuracy and clinic profile of FCGM data out of range in T2DM.

METHODS

FCGM data out of range were measured in T2DM patients at eight-time points of a day and compared with fingertip capillary blood glucose levels (REFs) as reference values.

RESULTS

A total of 307 out-of-range cases from 25,886 paired FCGM/REF data from 742 T2DM patients were evaluated. The distribution of "LO" and "HI" cases displayed the significant difference between eight-time points (P < 0.001) with the highest frequency (6.52%) of the "LO" value at 3 AM. The consistency rate between FCGM "LO" readings and REF < 40 mg/dl was far lower than that of FCGM "HI" readings with REF > 500 mg/dl (0.84% vs. 52.2%). In addition, the frequency of some clinical characteristics, including diabetes duration, hypoglycemia, hypertension, HbA1c, and Hb, were higher in patients with FCGM "LO" readings compared to those with "HI" readings.

CONCLUSIONS

These findings suggest the results and treatment regarding FCGM "LO" data should be interpreted with strong caution in the light of the emerging possible adverse measurement in patients.