REAL-WORLD EVIDENCE PUBLICATIONS

For each decile of time in range (TIR), the mean of daily scans, average glucose, estimated HbA1c, glucose standard deviation, glucose coefficient of variation, time in range, glucose time above 180 mg/dL and above 250 mg/dL, and the median of glucose time below 54 mg/dL and below 70 mg/dL were calculated. The group with the highest TIR showed significantly lower average glucose than the group with the lowest TIR. In addition, more time in range was associated with a lower glucose standard deviation, lower glucose coefficient of variation, lower TA250, lower TA180, lower TB70, and lower TB54. Greater TIR was also associated with significantly more daily scans. Mean scan frequency among all readers was 14.7 daily scans. In patients with diabetes from Chile, the use of the flash glucose monitoring system demonstrates the association between greater TIR, reduced glucose variability, reduced risk of hyperglycemia and hypoglycemia, and its association with greater engagement.

De-identified data were obtained between 2014 and 2021 from patients using the system uninterrupted for a 24-week period. Glycemic parameters during first and last sensor use were examined in four identifiable groups: type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) on basal-bolus insulin, T2DM on basal insulin, and T2DM without insulin treatment. Within each group, subgroup analyses were performed in persons with initial suboptimal glycemic regulation per the Time in Range consensus guidelines. Data were obtained from 1,909 persons with T1DM and 1,813 persons with T2DM (1,499 basal-bolus insulin, 189 basal insulin, and 125 non-insulin users). In most of the performed analyses, both overall and in the various subgroups, significant improvements were observed in virtually all predefined primary (TIR) and secondary endpoints (eHbA1c, TAR, TBR and glucose variability). 24-weeks of FreeStyle Libre use in real life by persons with T1DM and T2DM with suboptimal glycemic regulation is associated with improvement of glycemic parameters, irrespective of pre-use regulation or treatment modality.

Anonymous data were extracted for 1,600 users in the Czech Republic with ≥ 36 completed sensors from October 2018 to December 2021. “Experience” was defined by the number of sensors used. “Adherence” was defined by time between the end of one sensor and the start of the next (gap time). Low-adherence users reduced their sensor gap times significantly: 38.5% applied a new sensor within 24 h during sensors 4–6, rising to 65.0% by sensors 34–36. Improved adherence was associated with increased %TIR, reduced %TAR, and reduced glucose coefficient of variation. With experience, FreeStyle Libre users became more adherent in sensor reapplication, with associated increases in %TIR, and reductions in %TAR and glucose variability.

In the Mexican dataset, those in the lowest and in the highest groups scanned on average 3.9 and 40.8 times per day and had an estimated HbA1c of 7.18 and 6.74%, respectively (p < 0.05). In both populations, as scan frequency increased, time in range increased. In Mexico, the percentage of time in range increased from 65.0 to 68.4% (p < 0.05).  Similar to previous findings, increased scan frequency is associated with better glycemic control.

Mexican users performed an average of 14.9 scans per day vs. 13.2 scans per day worldwide (p < 0.05). In the Mexican dataset, those in the lowest and in the highest groups scanned on average 3.9 and 40.8 times per day and had an estimated HbA1c of 7.18 and 6.74%, respectively (p < 0.05). In both populations, as scan frequency increased, time in range increased. In Mexico, the percentage of time in range increased from 65.0 to 68.4% (p < 0.05).  Similar to previous findings, increased scan frequency is associated with better glycemic control.

higher frequencies of monitoring are associated with improvements in accepted measures of glucose control, including lower estimated HbA1c (8.6% to 7.3%) and increased time in range (44.5% to 61.3%), as well as less time in hyperglycaemia (50.2% to 33.8%) and clinically significant hypoglycaemia (1.3% to 0.5%). These results are aligned with those observed world-wide.

In January 2020, prior to the COVID-19 pandemic, the 65 years or older age group had the highest percentage time in range (TIR) (57.9%), while the 18-25 years age group had the lowest (51.2%). Within each age group, TIR increased during the analyzed months, by 1.7% (26-49 years) to 3.1% (≥65 years). The proportion of adults achieving both of the more than 70% TIR and less than 4% TBR targets increased from 11.7% to 15.9% for those aged 65 years or older and from 6.0% to 9.1% for those aged 18-25 years. Mean daily glucose-sensor scan rates were at least 12 per day and remained stable across the analysis period. During early COVID-19 lockdowns in the UK, the proportion of adults achieving TIR consensus targets increased among FSL users.

An association between glucose variability and hypoglycaemia was found. Both within-day-CV (wd-CV) and total-CV (t-CV) were associated with time below range. For achieving the consensus target of <1% time below 54 mg/dl, the associated wd-CV and t-CV values were 33.5% and 39.5%, respectively. The type of CV reported by the different continuous glucose monitoring systems should be acknowledged. CV <36% might not be adequate to ensure low hypoglycaemia exposure. Appropriate thresholds should be used to identify patients that would probably meet time below range targets (t-CV <40% or wd-CV <34%).

The data set for Saudi Arabia included 6097 readers, 35,747 sensors, and 40 million automatic glucose measurements. Higher scanning frequency in flash glucose users from Saudi Arabia is associated with lower eA1c, higher TIR, lower glucose variability and less time in hypoglycemia or hyperglycemia.

The data set included 12,370 readers, with data from 131,639 separate glucose sensors. In Israel, people with diabetes under real-world conditions recorded higher rates of FreeStyle Libre scanning. These higher scan rates were associated with improvements in time in range, estimated HbA1c, and reduced time with glucose levels of >180 mg/dL or <54 mg/dL.

Data comprising 16,331 readers (163,762 sensors) were analyzed. Increasing scan rates were associated with more time in range, less time in hyperglycemia, and a lower standard deviation of glucose. These outcomes among Dutch FLASH users suggest that with higher scan rate glycemic control improves.

This analysis used 5,804 readers from Argentina and 950,234 readers worldwide. A strong association was observed between highest scanning frequency and better glucose metrics, including less time below 54 mg/dL, less time above 250 mg/dL, lower estimated HbA1c level, lower glucose coefficient of variability (CV) and longer time within the therapeutic target (70 to 180 mg/dL). 

Data from the Polish population were collected from 10,679 readers and 92,627 sensors. The worldwide database included information from 981,876 readers and 11,179,229 sensors. On average, the users of isCGMS from Poland achieved lower estimated HbA1c, spent more time in range, and less time-above-range. The analyzed glucometrics improved as the scan rate frequency increased. The data also show that in real-life practice, a large number of patients may be willing to perform scanning more frequently than is usually assumed.

App users experienced lower glucose variability, lower average glucose, less time in hyperglycemia, and greater time in range than reader users. The observed differences may be driven by the data sharing features inherent in the app. By sharing glucose data with one’s clinical team, healthcare professionals and patients may be able to make more informed treatment decisions. 

The data comprised 688,640 readers and 7,329,052 sensors worldwide and included 17,691 readers and 147,166 sensors from Brazil. Similar to previous analyses, increased scan frequency was associated with better glycemic control – in this case, lower estimated HbA1c, lower time in hyperglycemia, and more time in range. 

Spanish users (n=22,949) collected 37.1 million glucose scans and checked glucose values via a mean of 13 scans/day. High scan rates were associated with the favorable glycemic markers of increased time-in-range and reduced time in hyperglycemia and hypoglycemia, and glucose variability

Data from 97,788 French patients from Sept 2014 - Sept 2018 were analyzed. When scan frequency was increased, estimated HbA1c was reduced, time in range was increased, and time in hypoglycemia was reduced. This study confirms that the frequency of FreeStyle Libre scans is associated with improved metabolic control, including time in range and time spent in hypoglycemia. 

De-identified glucose results from 6,802 users with at least six months of data were analyzed after dividing into high, medium and low-risk groups based on time spent in hypoglycemia or hyperglycemia. The analysis determined that under real-world conditions, flash monitoring was associated with rapid and sustained reduction in dysglycemia with high-frequency scanners demonstrating more significant reduction in hyperglycemia. 

Over 50,000 readers were included and over 90% of the data was from the seven initial FreeStyle Libre launch countries. Users performed an average of 16.3 glucose scans per day, almost four times more than average daily blood glucose checks previously reported. Higher scanning frequency was associated with better glycaemic measures including lower estimated HbA1c, decreased time in hyper and hypoglycemia and increased time in euglycemia with reduction in hypoglycemic exposure.