REFER Study

FreeStyle Libre system in T2D with basal-bolus insulin

Objective

Design

Results

Summary

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 & 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

Key Exclusion criteria

Pregnancy
Receiving dialysis treatment
Participation in a conflicting study

Primary outcome

Change in HbA1c levels from baseline (measured ≤3 months^† before starting FreeStyle Libre system) to an HbA1c measurement taken 3–6 months after commencement of device use^††.

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

HbA1c changes

Overall, mean HbA1c decreased by 9.7 mmol/mol ± 0.6 (0.9% ± 0.05, p < 0.0001) from baseline to the final phase: from 73.3 mmol/mol ± 9.8 (8.9% ± 0.9) to 63.6 ± 10.6 mmol/mol (8.0% ± 1.0). A1c changes per country were as follows (Table 2, Fig 1).

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.

References & Disclaimers

Images are for illustrative purposes only. Not real patient data. Study data collected with the FreeStyle Libre system and is applicable to the FreeStyle Libre 2 & FreeStyle Libre 3 systems based on technological similarities.

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.

† 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.

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REFER Study

FreeStyle Libre system in T2D with basal-bolus insulin