.svg){kind=logo}
To evaluate the impact of the FreeStyle Libre system on HbA1c levels in type 2 diabetes treated with basal insulin.
Elliott et al. 2021 study
Evaluating the impact of the FreeStyle Libre system₼ in type 2 diabetes managed with basal insulin
Real-world data - impact on the HbA1c levels in patients with type 2 diabetes on basal insulin
Introduction of basal insulin analogs has become a standard of care for type 2 diabetes, but many patients do not achieve the desired level of glycaemic control.1 Elliott et al. 2021 reported findings from a real-world study that evaluated changes in HbA1c, in patients with basal insulin-treated type 2 diabetes.2
Use of the FreeStyle Libre system improved HbA1c levels in patients with type 2 diabetes on basal insulin.
Study objective
Study design and study population
The Elliott et al. 2021 study was a retrospective non-interventional single arm real-world study designed to evaluate changes in HbA1c in adults with type 2 diabetes managed with basal insulin.
The study was conducted at six diabetes centres in Canada, where data was obtained between November, 2017 and May, 2020.
Ninety-one anonymised medical records were used in the primary endpoint analysis. Adults with type 2 diabetes who were on a basal only insulin regimen for at least one year and who used the FreeStyle Libre flash glucose monitoring system for at least three months, were included.
The study compared the differences between HbA1c at baseline and 3–6 months after initiating device use. Baseline HbA1c was defined as measured 90 days or less before the patient commenced use of flash glucose monitoring. After commencing device use, HbA1c levels were monitored 90–194 days later.
Key Inclusion criteria†
Key Inclusion criteria†- Participant’s age >18 years old
- Diagnosed with type 2 diabetes and on basal insulin regimen for ≥1 year
- FreeStyle Libre system use for ≥3 months
- HbA1c levels of 8%–12% within three months prior to device use and HbA1c results recorded 3–6 months after starting device use
Key Exclusion criteria†
Key Exclusion criteria†- Prandial insulin after device use initiation
Primary outcome
Study results2
Change in HbA1c analysed by subgroups
![The study included 100 participants randomised in to two study arms (FreeStyle Libre, intervention arm [n=49]); SMBG, control arm [n=50]). There was no significant difference in maternal baseline characteristics between the two groups.](/at-de/wissensdatenbank/scientific-evidence/clinical-and-real-world-evidence-studies/Elliott-Study/_jcr_content/root/container_172510131/image.coreimg.png/1756903252820/change-in-hba1c-analysed-by-subgroups-1.png)
Change in HbA1c by baseline HbA1c, age group, sex, duration of insulin therapy, Boss Mass Index (BMI) , and Blood glucose (BG) test frequency at baseline (mean and 95% confidence interval).
Summary
The retrospective study by Elliott et al. showed a significantly reduced HbA1c 3-6 months after initiation of flash glucose monitoring with the FreeStyle Libre system to further support management of type 2 diabetes treated with basal insulin.
₼ Sales of the original FreeStyle Libre system has been discontinued in EU & UK markets. In these markets, the FreeStyle Libre 2 and 3 systems are for sale, providing the same benifits as the original FreeStyle Libre system, with the added functionalities of optional Real-Time Alarams.
CI= confidence interval
†A full list of inclusion/exclusion criteria can be found at Elliott et al., 2021.2
References
1. Forst, Thomas et al. (2020): A practical approach to the clinical challenges in initiation of basal insulin therapy in people with type 2 diabetes. In Diabetes Metabolism Research and Reviews 37(6), pp. e3418. DOI: 10.1002/dmrr.3418.
2. Elliott, Tom et al. (2021): The impact of flash glucose monitoring on glycated hemoglobin in type 2 diabetes managed with basal insulin in Canada: A retrospective real-world chart review study. In Diabetes and Vascular Disease Research 18(4), pp. 14791641211021374. DOI: 10.1177/14791641211021374.
FOLGEN SIE UNS: