Sensor Academy

RELIEF study1

FreeStyle Libre system₼ lowers acute diabetes complication rate

HCP with monitor
HCP with monitor
HCP with monitor
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Impact of flash glucose monitoring on ketoacidosis rate

The longitudinal retrospective observational real-world cohort study RELIEF demonstrates that following initiation of the FreeStyle Libre (FSL) system₼ the incidence of diabetic ketoacidosis was reduced for both type 1 diabetes (T1D) and type 2 diabetes (T2D) patients in France, especially in patients with very low and very high adherence to self-monitoring blood glucose (SMBG). 

The data suggest that FSL allowed people with diabetes to detect and limit persistent hyperglycaemia, and subsequently ketoacidosis.1 The results were published in the high-profile journal Diabetes care by Roussel and colleagues.1

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Study objective

The RELIEF study assessed rates of hospitalisation for acute diabetes complications in France before and after initiation of the FreeStyle Libre system.1

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Study design and study population

RELIEF study design1

➤ The RELIEF study was conducted as a longitudinal retrospective cohort study.

➤ Data source was the French nationwide reimbursement claim database SNDS.

➤ Data on hospitalisation related to acute diabetic complications were recorded in the year prior to first FreeStyle Libre sensor claim (index date for initiation), and in the year after (FSL users Aug 1, 2017–Dec 31, 2017).

➤ Blood test strip usage was determined based on reimbursement for 12 months prior to FreeStyle Libre system initiation.

RELIEF study population1

➤ 33 165 people with T1D and 40 846 people with T2D, initiating the FreeStyle Libre system during the study period (2017/08/01 to 2017/12/31) were identified. Patients of all ages were included and were not stratified by age.

➤ Patients on multiple daily injections (MDI; n=46 828) and continuous subcutaneous insulin infusion (CSII; n=18 593) accounted for 88 % of the study population. Patients with T2D treated with a single basal insulin injection or with oral agents only accounted for 12 % of the study population.

Data on hospitalisation related to acute diabetic complications before and after availability of the FreeStyle Libre system were collected based on their ICD-10 codes:

➤ T1D with ketoacidosis

➤ T2D with ketoacidosis

➤ Drug-induced hypoglycaemia without coma

➤ Other hypoglycaemia

➤ Hypoglycaemia, unspecified

➤ Poisoning by adverse effects of insulin and oral hypoglycaemic

➤ T1D with coma

➤ T2D with coma

➤ Diabetes unspecified with coma

➤ Hyperglycaemia-related stays

About diabetic ketoacidosis

  • Diabetic ketoacidosis, or DKA, is a serious metabolic derailment in the case of insulin deficiency, which requires immediate intensive medical treatment.
  • Diabetic ketoacidosis is a form of metabolic acidosis due to the increased formation of ketone bodies.
  • DKA can be a complication in T1D or T2D as a consequence of severe insulin deficiency. The glucose can no longer enter the cells in sufficient quantities and is no longer available to the body as an energy source.
  • The body then covers its energy requirements by breaking down fats which leads to an increased accumulation of ketone bodies.
  • As a consequences acidemia may develop. High glucose levels spill over into the urine, taking water and electrolytes along with it in a process known as osmotic diuresis. The consequences of these changes ultimately stemming from hyperglycaemia are polyuria, dehydration, and polydipsia. 
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Study results

Reduced incidence of hospitalisation in patients using
the FreeStyle Libre system1

Hospitalisations for acute diabetes complications fell by 49,0 % in people with T1D and by 39,4 % in people with T2D following initiation of the FreeStyle Libre system (Figure 1).



Annual percentage of patients with T1D–related and T2D–related acute events before and after initiation of
the FreeStyle Libre system

Figure 1: Annual percentage of patients with T1D-related (A) and T2D-related (B) acute complications before and after initiation of the FSL system. The data show the percentage of patients with at least one acute diabetes complication in the 12 months before and after FreeStyle Libre system initiation.

➤ Reduced incidence of hospitalisation for DKA and diabetes-related comas and dysglycaemia in patients using the FreeStyle Libre system1

➤ Overall hospitalisation rates for DKA was reduced by 56,2 % in T1D (Figure 1a) and 52,1 % in T2D (Figure 1b).

➤ Diabetes-related comas were reduced by 39,6 % in T1D and by 31,9 % in T2D following the initiation of the FreeStyle Libre system (Figure 1 a,b).

➤ Hospitalisations rates for hypoglycaemia and hyperglycaemia in people with T2D decreased by 10,8 % and 26,5 %, respectively (Figure 1b).

Hospitalisations classified by use of SMBG tests

Figure 2: Hospitalisations for acute diabetes complications classified by use of SMBG tests for the total study population. Data show rates of hospitalisations with acute diabetes complications in the 12 months before and after FreeStyle Libre initiation.

➤ The reduction in hospitalisation rate in the total study population was most marked for people who were noncompliant with SMBG and for those with highest acquisition of SMBG before FreeStyle Libre initiation (Figure 2).

➤ This result was consistent in the T1D and T2D subpopulations.

➤ The reduction in rates of hospitalisation with acute diabetes complications in the total study population was
54,0 % for patients using 0 SMBG tests/day and 51,2 % for patients using >5 tests/day, respectively (Figure 2).

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Summary

The retrospective observational real-world nationwide cohort study RELIEF shows that for people with intensively insulin-treated diabetes access to the FreeStyle Libre system is associated with a subsequent drop in rates of hospitalisations for acute diabetes complications. The effect is most marked in patients with very low and very high adherence to SMBG.

TYPE 1D

  • Overall reduction in hospitalisation rates for DKA by 56,2 %
  • Overall reduction in hospitalisation rates for diabetes-related comas by 39,6 %
  • Independent from treatment with MDI or CSII

TYPE 2D

  • Overall reduction in hospitalisation rates for DKA by 52,1 %
  • Overall reduction in hospitalisation rates for diabetes-related comas by 31,9 %
  • Overall reduction in hypoglycaemia by 10,8 %
  • Overall reduction in hyperglycaemia by 26,5 %
  • Independent from treatment with MDI or CSII
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Images are for illustrative purposes only.

SNDS= Système National des Données de Santé; T1D= type 1 diabetes; T2D= type 2 diabetes
₼ 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.

References

1. Roussel R et al. Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or T2D After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care 2021; 44(6):1368–76. DOI: 10.2337/dc20-1690.

ADC-2693665  V1.0 06/26

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