YARON et al. study

Effect of flash glucose monitoring technology on glycaemic
control and treatment satisfaction in patients

with type 2 diabetes
 

Effect of FreeStyle Libre
system in patients with type 2
diabetes on MDI

The open-label randomised (1:1) controlled trial demonstrates a high satisfaction and a significant reduction in A1c among users of the FreeStyle Libre system* vs. self-monitoring of blood glucose (SMBG) without an increased frequency of hypoglycaemia.


The FreeStyle Libre system led to improved treatment satisfaction and better glycaemic control in patients with T2D on multiple daily injections (MDI). 

Study objective

Assess treatment satisfaction and the effectiveness of the FreeStyle Libre system in patients with T2D diabetes using insulin.

Study design and study population

The trial was conducted at two diabetes centres in Israel and recruited 101 participants with T2D for at least one year and on multiple daily insulin injections (MDI). The aim was to assess treatment satisfaction and the effectiveness of flash glucose monitoring in this patient population.1

  • The trial was conducted as an open-label randomised controlled study at two centres in Israel for a period of 10 weeks. 
  • Participants (n=101) were randomised in a 1:1 ratio to the intervention group using the FreeStyle Libre system (n=53) or to the control group using SMBG (n=48).  
  • The authors evaluated treatment satisfaction, quality of life, comfort using flash glucose monitoring, HbA1c and frequency of hypoglycaemic events. 
  • In a post-hoc analysis, a significant reduction in HbA1c was defined as achieving a difference in HbA1c of ≥ 0.5% (5.5 mmol/mol) or ≥1% (10.9 mmol/mol)  

 

 Inclusion criteria

  • T2D ≥ 1 year 
  • Age: 30-80 years
  • Treated with MDI (≥ 2 injections daily) for at least six months   
  • HbA1c: 7.4% to 10.2% (57–88 mmol/mol) 
  • Willingness to measure blood glucose seven times a day, at least one day a week

 

 Key exclusion criteria

  • T1D 
  • Cardiovascular event within the last six months 
  • Proliferative diabetic retinopathy  
  • Creatinine ≥2 mg/dL 
  • Pregnancy or planned pregnancy 



 

Primary outcome

Key secondary outcomes 

Study results

Key patient baseline characteristics1†

The study included 101 participants randomised in a 1:1 ratio to the intervention group using the FreeStyle Libre system (n=53) or to the control group using SMBG (n=48) (Table1).

Table 1 - Baseline demographic and clinical characteristics of participants with T2D assigned randomly to the intervention or control group

Primary outcome results

Table 2 - DTSQc scores at the end of the study

DTSQc= Diabetes Treatment Satisfaction Questionnaire change version

Table 3 - Change in mean DTSQs score (± SD) for perceived frequency of hypoglycaemia after 10 weeks
(imputed data)

DTSQc= Diabetes Treatment Satisfaction Questionnaire change version

Secondary outcome results 

Figure 1 – Relationship between baseline HbA1c and change in HbA1c by treatment group

A significant decrease in HbA1c of ≥0.5% (5.5 mmol/mol) at week 10 was observed in 68.6% of participants using the FreeStyle Libre system vs. 30.2% of those using SMBG (p<0.001); 39.2% decreased their HbA1c by ≥1.0% (10.9 mmol/mol) vs. 18.6% of the control group (p=0.023), without an increased frequency of hypoglycaemia (Fig 2).

Figure 2 – Reduction in HbA1c

  Key takeaways

Study limitations

➤ The power of the primary outcome may have been undermined due to a number of participants not being willing to complete the questionnaires. 

Summary

     

This 10-week randomised controlled trial indicates that using FreeStyle Libre system technology in patients with T2D on MDI may lead to an improvement in treatment satisfaction and a significant reduction in HbA1c without increased risk of hypoglycaemia. 
 

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

† A list of all inclusion criteria, exclusion criteria and baseline characteristics can be found in the publication.1

Reference

1. Yaron M, et al. Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes. Diabetes Care. 2019;42(7): 1178-1184. https://doi.org/10.2337/dc18-0166.

Abbreviations

DTSQ = Diabetes Treatment Satisfaction Questionnaire; DTSQc= DTSQ change version; DTSQs = DTSQ status version

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