The Impact of the FreeStyle Libre^TM Flash Glucose Monitoring System on Glycemic Control in Patients with Diabetes; Observational Multicenter 15-Months Study

Abstract

Objectives: The study was to determine the impact of using the FreeStyle Libre TM flash glucose monitoring system on glycemic control and the rate of events due to diabetes in people with diabetes from different types and age groups. Methods: a retrospective cohort chart review study was carried out at three centers in the Taif region in the Kingdom of Saudi Arabia: The study was approved by an accredited centralized institutional review board. Paper or electronic medical records were included for individuals of any age with diabetes (type 1, type 2, gestational diabetes) managed with diet, insulin therapy, or/and oral antihyperglycemic medication and/or non-insulin injection therapy. The primary outcome measure was the laboratory HbA1c level as well as reduction. Secondary outcome measures were frequency of severe hypoglycemia, admission to hospital or ER visit related to diabetes complications, and severe hyperglycemia (DKA or HHS). Results: Data was analyzed from 1695 patients. The average HbA1c before using the flash glucose monitoring system was 9.60% ± 1.44% and 3 months HbA1c after using the FreeStyle Libre TM flash glucose monitoring system was 8.70% + 1.45% for a difference of -0.90% ([95% CI -0.92: -0.88]; p < 0.0001). The 6 months HbA1c was 8.17% + 1.53% for a difference of -1.47% ([95% CI -1.50: -1.44]; p < 0.0001). The 12 months HbA1c was 7.87% + 1.56% for a difference of -1.85% ([95% CI -1.88: -1.81]; p < 0.0001). There was a highly significant reduction in HbA1c over time after using the flash glucose monitoring system. The reduction in HbA1c is consistent among all subgroups; namely GDM on a diet, GDM on insulin, type 1 adult, type 1 children, type 1 pregnant women, type 2 on a diet, type 2 on OAD, type 2 on basal insulin plus OAD, type 2 on multiple-dose insulin, and type 2 pregnant women, obese, non-obese, males, females, age group < 65 & age group > 65 years, (p-values < 0.001). Severe hypoglycemia 3 - 6 months before using the flash glucose monitoring system was 9.56 ± 1.73 versus 0.52 ± 0.50 in the last six months of the study (p-value < 0.001). Hyperglycemic hyperosmolar state or diabetic ketoacidosis 3 - 6 months before using the flash glucose monitoring system was 7.40 ± 2.26 versus 0.49 ± 0.50 in the last six months of the study (p-value < 0.001). Emergency room visits & hospital admissions due to diabetes complications 3 - 6 months before using the flash glucose monitoring system were 1.98 ± 0.81 versus 0.49 ± 0.50 in the last six months of the study (p-value < 0.001). Conclusion: The benefits of using the FreeStyle Libre TM flash glucose monitoring system are self-evident in reducing HbA1c and events due to hyperglycemia or hypoglycemia.