The study, published in The New England Journal of Medicine, evaluated adults with type 1 diabetes and suboptimal glycemic control. It demonstrated significant reductions in glycated hemoglobin (HbA1c) compared to self-monitoring of blood glucose. Subjects sustained HbA1c reductions for the study duration of 24 weeks.
Abbott also reported links between FreeStyle Libre 2 and improvements in participant-reported quality of life outcomes. Those include overall satisfaction and reduction in burden associated with glucose monitoring.
Following six months of use, FreeStyle Libre 2 users reduced HbA1c levels by an average of 0.8% (8.7% to 7.9%). People self-monitoring blood glucose reduced HbA1c levels by 0.2% (8.5% to 8.3%).
“Continuous glucose monitoring has been a critical tool for people living with diabetes, both to avoid painful fingersticks and to help manage glucose levels,” said study author Dr. Lalantha Leelarathna from the University of Manchester NHS Foundation Trust. “This data adds to the growing body of evidence that demonstrates the technology helps bring HbA1c levels closer to the target range, which ultimately decreases risks of further complications.”
The trial included 156 people aged 16 years or older with type 1 diabetes. The participants had HbA1c levels between 7.5% and 11%, having never previously used continuous glucose sensing technology. For 24 weeks, the study randomized half the participants between FreeStyle Libre 2 and self-monitoring.
Abbott said the average HbA1c level registered 0.3% lower at 12 weeks and 0.5% lower at 24 weeks. These represent statistically significant changes compared to those self-monitoring. FreeStyle Libre 2 users also presented a greater likelihood of reducing HbA1c by a full percentage point by the end of the study period.
Users of the CGM spent an additional 130 minutes per day with glucose levels in the target range (70-180 mg/dL). They spent 43 minutes per day less time with dangerously low glucose levels (<70 mg/dL).
“This randomized study clearly illustrates the importance of continuous glucose monitoring for adults with Type 1 diabetes,” said Dr. Mahmood Kazemi, CMO for Abbott’s diabetes care business. “This clinically-significant change in HbA1c levels shows FreeStyle Libre technology empowers people to make lifestyle decisions that improve their glucose control and, ultimately, may result in a reduction in diabetes-related health problems down the line.”
The study marks part of FLASH-UK, the first randomized trial for FreeStyle Libre 2 compared to self-monitoring. A team at The University of Manchester led the trial. Investigators from eight centers in the UK (Birmingham, Cambridge, Derby, Dorset, Ipswich, Manchester, Norwich and Portsmouth) participated. Diabetes UK funded the study. Abbott had no involvement in the execution or funding of the study.
Positive data follows last month’s announcement of reduced hospitalizations associated with FreeStyle Libre 2. Findings from the RELIEF study included a significant reduction of the rate of hospitalizations due to acute diabetes events (ADEs). This study evaluated people living with type 2 diabetes on once-daily (basal) insulin therapy.
FreeStyle Libre features a sensor applied to the back of the upper arm for 14 days. It continuously measures glucose while paired with a compatible smartphone app or reader for displaying glucose levels.
