Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies.

INTRODUCTION: Real-world evidence (RWE) confirms that reductions in HbA1c for children and adults with type 1 diabetes (T1DM) and adults with type 2 diabetes (T2DM) are associated with use of the FreeStyle Libre system. This current meta-analysis aims to investigate whether HbA1c benefits are sustained over 24 months and to identify patterns of change in HbA1c for users of the FreeStyle Libre system for people living with T1DM or T2DM. METHODS: A bibliographic search up to December 2020 identified 75 studies reporting data on change in lab HbA1c in 30,478 participants with type 1 (n = 28,063; 62 trials) or type 2 diabetes (n = 2415; 13 trials) using the FreeStyle Libre system, including observations on children, adolescents and adults. Meta-analysis was performed using a random effects model. RESULTS: Reductions in HbA1c at 3-4 months were similar for adults with T1DM (- 0.53%, 95% CI - 0.69 to - 0.38) or with T2DM (- 0.45%, 95% CI - 0.57 to - 0.33), continuing through 4.5-7.5 months in T1DM (- 0.42%, 95% CI - 0.58 to - 0.27) and in T2DM (- 0.59%, 95% CI - 0.80 to - 0.39). Meta-regression analysis shows that higher starting HbA1c is correlated with greater reductions in HbA1c in T1DM and in T2DM. These patterns of change in HbA1c were sustained for 24 months in T1DM and for at least 12 months in T2DM. CONCLUSIONS: Meta-analysis of RWE confirms that using the FreeStyle Libre system is associated with significant reductions in HbA1c for adults with T1DM or with T2DM. Reductions are greater for people with higher baseline HbA1c and are sustained for 24 and 12 months in T1DM and TD2M respectively.

The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies.

INTRODUCTION: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. METHODS: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. RESULTS: Overall mean change in laboratory HbA1c across study subjects at 2-4 months was - 0.55% (95% CI - 0.70, - 0.39). Amongst the 1023 adults, mean change in HbA1c was - 0.56% (95% CI - 0.76, - 0.36); for the 447 children and adolescents, mean change in HbA1c was - 0.54% (95% CI - 0.84, - 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. CONCLUSION: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. FUNDING: Abbott Diabetes Care.

Performance of a new test strip for freestyle blood glucose monitoring systems.

BACKGROUND: a new strip, designed to enhance the ease of use and minimize interference of non-glucose sugars, has been developed to replace the current FreeStyle (Abbott Diabetes Care, Alameda, CA) blood glucose test strip. We evaluated the performance of this new strip. METHODS: laboratory evaluation included precision, linearity, dynamic range, effects of operating temperature, humidity, altitude, hematocrit, interferents, and blood reapplication. System accuracy, lay user performance, and ease of use for finger capillary blood testing and accuracy for venous blood testing were evaluated at clinics. Lay users also compared the speed and ease of use between the new strip and the current FreeStyle strip. RESULTS: for glucose concentrations <75 mg/dL, 73%, 100%, and 100% of the individual capillary blood glucose results obtained by lay users fell within ± 5, 10, and 15 mg/dL, respectively, of the reference. For glucose concentrations ≥75 mg/dL, 68%, 95%, 99%, and 99% of the lay user results fell within ± 5%, 10%, 15%, and 20%, respectively, of the reference. Comparable accuracy was obtained in the venous blood study. Lay users found the new test strip easy to use and faster and easier to use than the current FreeStyle strip. The new strip maintained accuracy under various challenging conditions, including high concentrations of various interferents, sample reapplication up to 60 s, and extremes in hematocrit, altitude, and operating temperature and humidity. CONCLUSIONS: our results demonstrated excellent accuracy of the new FreeStyle test strip and validated the improvements in minimizing interference and enhancing ease of use.

The role of the benchmark dose in a regulatory context.

The use of no observed adverse effect levels (NOAELs) as a way of interpreting toxicology studies carries a number of problems, and the benchmark dose (BMD), or its lower confidence limit have been proposed as potential replacements. In practice, the theoretical advantages of the BMD approach are often outweighed by the practical disadvantages posed in a regulatory context. Attempts to seek consensus for the routine use of BMD methodology tend to involve diluting its potential advantages as much as they address the disadvantages, resulting in a relatively complex interpolation tool that delivers little more than the NOAEL. It is time to recognise that the BMD will never entirely replace the NOAEL. The two methods can have complementary roles. The NOAEL is well suited as a routine simple summary of effects in toxicology studies, whilst the BMD can be a higher tier approach for the interpretation of the most critical studies in a regulatory data package.