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 | 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 HbA1c 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).
Assess treatment satisfaction and the effectiveness of the FreeStyle Libre system in patients with T2D diabetes using insulin.
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
Primary outcome➤ Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ) at week 10.
Key secondary outcomes ➤ Improvement of HbA1c
➤ Changes in total hypoglycaemic events <3,0 mmol/L and <3,9 mmol/L at week 10
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 resultsHigh 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 3 – Change in mean DTSQs score (± SD) for perceived frequency of hypoglycaemia after 10 weeks (imputed data)
Secondary outcome resultsSignificant reduction in HbA1c and no differences in frequency of hypoglycaemic episodes
➤ Use of the FreeStyle Libre system, with adjustment for HbA1c 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 HbA1c and change in HbA1c by treatment group
There is a statistically significant difference in the mean change in HbA1c between treatment groups in favour of the intervention (p< 0.0001).
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➤ 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 HbA1c without an increased frequency of hypoglycaemia.
➤ The power of the primary outcome may have been undermined due to a number of participants not being willing to complete the questionnaires.
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.
Images are for illustrative purposes only.
₼ Sales of the original FreeStyle Libre system have been discontinued in EU & UK markets. In these markets, the FreeStyle Libre 2 and 3 systems are for sale, providing the same benefits as the original FreeStyle Libre system, with the added functionalities of optional Real-Time Alarms.
† 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-2637523 v2.0
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