REFER study

FreeStyle Libre system in T2D with basal-bolus insulin
 

Evaluating the FreeStyle Libre system in type 2 diabetes managed with basal-bolus therapy

REFER investigated the impact of the FreeStyle Libre system on HbA1c in type 2 diabetes (T2D) managed with basal-bolus insulin treatment.1 



Real-world data were collected in 3 parallel, retrospective, non-interventional chart review studies of type 2 diabetes patients using the FreeStyle Libre system at diabetes centres in Austria, France and Germany. 



In these real-world settings, using the FreeStyle Libre system for 3–6 months significantly reduced HbA1c levels in people with T2D managed with basal-bolus insulin therapy.

Study objective

Evaluate the efficacy of the FreeStyle Libre system on glycaemic control in patients with T2D managed by basal-bolus insulin therapy in real-world clinical settings. 

Study design and study population

REFER comprised 3 parallel, retrospective, non-interventional, single-arm chart review studies conducted in Austria, France and Germany (6 centres per country).

 Key Inclusion criteria

  • ≥18 years
  • T2D
  • On basal-bolus insulin regimen for ≥1 year
  • Use of FreeStyle Libre system for ≥3 months at time of data collection 
  • Baseline HbA1c of 64–108 mmol/mol (8.0 %-12.0%) 
  • HbA1c measurement 3–6 months after initiation of device use

 Exclusion criteria

  • Pregnancy
  • Receiving dialysis treatment  
  • Participation in a conflicting study




 

Primary outcome

Subgroup analyses (all countries)

Baseline HbA1c

<75 mmol/mol (<9.0%)

≥75 mmol/mol (≥9.0%)

Duration of insulin use
<9 years
≥9 years

Age

<65 and ≥65 years

BMI

<30 and ≥30

Sex

Study results

Key patient baseline characteristics1

A total of 363 medical records were included in the meta-analysis (92 from Austria, 88 from France and 183 from Germany). Baseline demographic and clinical characteristics were similar across all countries (Table 1, Fig 1). 

Table 1 - Baseline characteristic and demographic data 

Primary outcome

Table 2 - Change from baseline in HbA1c  

Figure 1 – Change in HbA1c from baseline per country and overall

Graph showing mean and 95% confidence interval for change in HbA1c between baseline and final per country and overall

Subgroup analyses

In all three countries:


➤ HbA1c decrease was more pronounced in patients with baseline HbA1c levels ≥75 mmol/mol (≥9.0%) (Fig 2).
➤ HbA1c improvements were seen across age, sex, duration of insulin use and BMI categories (Fig 2).
          ➣ No significant difference in HbA1c effects was seen between subgroups of these categories.

Figure 2 – Change in HbA1c from baseline per subgroup analysis

Graph showing mean and 95% confidence intervals for change in HbA1c by baseline HbA1c , age, sex, duration of insulin therapy and BMI.

Summary

REFER was the first analysis of real-world data to demonstrate the beneficial impact of FreeStyle Libre system on HbA1c levels in type 2 diabetes patients treated with basal-bolus insulin. 

After 3–6 months of use, the FreeStyle Libre system significantly reduced HbA1c levels in T2D patients on a basal-bolus insulin regimen.

Study data collected with the FreeStyle Libre system and is applicable to the FreeStyle Libre 2 & FreeStyle Libre 3 systems based on technological similarities.

If >1 HbA1c test result was available, the result closest to the index date was extracted for use.


Test performed ≥90 days but <194 days after initiating Freestyle Libre; if >1 HbA1c result was available, the result closest to 135 days after the index date was used.


References

1 Kröger J, Fasching P, Hanaire H. Three European retrospective real-world chart review studies to determine the effectiveness of flash glucose monitoring on A1c in adults with type 2 diabetes. Diabetes Ther. 2020;11(1):279-291. doi:10.1007/s13300-019-00741-9.

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