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The objective of the study was to compare the time in range (70-180 mg/dL) of flash glucose monitoring with SMBG over 14 days at baseline and after 8 weeks of open-label system use for diabetes self-management, including insulin dosing. Key secondary endpoints included HbA1c, time in hypo- and hyperglycaemia, and treatment satisfaction.
SELFY study
Benefits of FreeStyle Libre system₼ in young people with diabetes
Assessment of the FreeStyle Libre system₼ for day-to-day management in paediatric patients1
Successful diabetes management is dependent on effective self-management. Young people (children and adolescents) with diabetes and their families need help and support to achieve this.
The FreeStyle Libre system (FSL) significantly increases the amount and availability of detailed glucose data, while significantly reducing the time and pain issues associated with self-monitoring of blood glucose (SMBG).2,3
With the FSL system, users can observe their current glucose level, glucose trend data and glucose patterns conveniently by scanning a sensor worn on the back of the arm.
Published in Pediatric Diabetes, the SELFY study was a prospective, single-arm, non-inferiority multicentre study by Campbell et al.1
It evaluated the use of flash glucose monitoring with the FSL system in children and teenagers with type 1 diabetes.1
The primary endpoint was the equivalence of time in range (70-180 mg/dL) using the flash glucose monitoring device and SMBG during the final fortnight of the treatment phase (days 57-70) compared to SMBG use only during baseline (days 1-14).1
In the independent SELFY study, the FSL system was shown to improve glycaemic control in children with diabetes compared to the use of SMBG in a single arm study1
Study objective
Study design and study population
SELFY was a clinical study designed to establish if the FSL system can help maintain glycaemic control in paediatric populations. It was a multi-centre, prospective, single-arm study, conducted at 10 European diabetes centres (seven in the UK, two in the Republic of Ireland and one in Germany). A total of 76 participants aged between 4–17 years with type 1 diabetes were enrolled between June 27, 2016 and November 30, 2016.
For this study, the FSL system was ‘masked’ for the first 14 days; to provide baseline data for the study analysis, during this time they used the reader blood glucose strip port for routine self-monitoring and not sensor glucose measurements. After the first 14 days, the system was unmasked and used by the participant according to the labelling as part of their glucose management.
Key Inclusion criteria
Key Inclusion criteria- Participants were aged between ≥4 years and ≤17 years, with an identified caregiver of ≥18 years
- Type 1 diabetes for at least 1 year and were treated with insulin administered by injections in multiple daily injections (MDI) or continuous subcutaneous insulin infusions (CSII)
- Their insulin regimen was unchanged for at least two months prior to enrolment and no plans to change the regimen
- Participants needed to be testing blood glucose levels on average at least twice a day on average
Key Exclusion criteria
Key Exclusion criteria- Known (or suspected) allergy to medical grade adhesives
- Currently using or planning to use the FSL system or a continuous glucose monitoring (CGM) device during the study
- Use of the FSL system or a CGM device in the previous three months
- Currently prescribed oral steroid therapy
- Pregnant or breast feeding
Study results
Key patient baseline characteristics1
The study included 76 participants with type 1 diabetes, aged 4 to 17 years, who wore the system in masked mode for 14 days and then in unmasked mode for 8 weeks for diabetes self-management, including insulin dosing.
Baseline characteristics
CSII: continuous subcutaneous insulin infusion; MDI: multiple daily injections; sd: standard deviation.
Primary and secondary outcomes
Study limitations
Short-term use of the FSL system in a cohort with reasonable glycaemic control for this population. The study had relatively small participant numbers in each age sub-group and no control group for comparison.
Summary
The SELFY study has shown superiority of The FreeStyle Libre system over SMBG in young people with type 1 diabetes1
- SELFY was a prospective, single-arm, non-inferiority, multicenter study that evaluated the use of flash glucose monitoring with the FreeStyle Libre system in children and teenagers with type 1 diabetes.
- The study compared the time in range (70-180 mg/dL) of flash glucose monitoring with SMBG over 14 days at baseline and after 8 weeks of open-label system use for diabetes self-management including insulin dosing.
- Flash glucose monitoring (FSL) improved time in range by 0.9 ± 2.8 h/d and reduced time in hyperglycaemia (>180 mg/dL) by -1.2 ± 3.3 h/d compared to SMBG.
- The FreeStyle Libre system use also reduced HbA1c by -0.4 % (-4.4 mmol/mol) from baseline to study end, with reductions across all age-subgroups (4–6, 7–12 and 13–17 years).
- The FreeStyle Libre system was well-utilised and well-tolerated by the participants, and improved treatment satisfaction for parents and teenagers.
- The study concluded that children with diabetes improved glycaemic control safely and effectively with short-term flash glucose monitoring compared to use of SMBG.
₼ 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.
References
1. Campbell FM et al., Pediatr Diabetes. 2018; 19: 1294–1301.
2. Haak T et al. Diabetes Ther. 2017; 8(1):55–73.
3. Bolinder J., Lancet (2016): https://doi.org/10.1016/S0140-6736(16)31535-5.
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