YARON study

YARON et al. study

Effect of flash glucose monitoring technology on glycaemic
control and treatment satisfaction in patients
 with type 2 diabetes

Objective

Design

Results

Summary

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, A1c and frequency of hypoglycaemic events.
In a post-hoc analysis, a significant reduction in A1c was defined as achieving a difference in HbA1c of ≥ 0.5% (5.5 mmol/mol) or ≥1% (10.9 mmol/L)

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

➤ Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction
Questionnaire' (DTSQ) at week 10.

Key secondary outcomes

➤ Improvement of A1c   

➤ Changes in total hypoglycaemic events <54 mg/dL and <70 mg/dL at week 10

Study results

Key patient baseline characteristics^1†

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).

Primary outcome results

High satisfaction using the FreeStyle Libre system in T2D on MDI

➤ Patient satisfaction with diabetes treatment was high in both study groups; the mean score per subject for each question in the DTSQ was higher in the intervention group (Table 2, Table 3).

Table 2 - DTSQc scores at the end of the study

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

(imputed data)

Secondary outcome results

Significant reduction in HbA1c and no differences in frequency of hypoglycaemic episodes

➤ Use of the FreeStyle Libre system, with adjustment for A1c values at baseline, led to a significantly higher reduction in HbA1c in the intervention group (-0.85% [9.3 mmol/mol]) vs. the control group (-0.32% [3.5 mmol/mol]; p<0.0001) (Fig 1).

Figure 1 – Relationship between baseline A1c and change in A1c by treatment group

A significant decrease in A1c 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 A1c 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).

Key takeaways

➤ Patient satisfaction with diabetes treatment was high in both study groups, with a higher mean score per subject for each question in the intervention group.

➤ Patients in the intervention group would recommend treatment by FreeStyle Libre system significantly more to their counterparts.

➤ Overall satisfaction with the FreeStyle Libre system was high, with 87.5% of the intervention group feeling very satisfied with using it.

➤ Patients in the intervention group found treatment by FreeStyle Libre system significantly more flexible.

➤ Perceived frequency of hypoglycaemia improved significantly for the intervention group compared with the control group.

➤ Use of the FreeStyle Libre system led to a significantly higher reduction in A1c without an increased frequency of hypoglycaemia.

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 A1c without increased risk of hypoglycaemia.

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

* The FreeStyle Libre system is available in both mmol/L and mg/dL versions depending on the country.
†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

ADC-89715 v1 09/24

YARON et al. study

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

Study objective