RELIEF study follow-up

Long-term reduction of hospitalisation for ketoacidosis

Long-term impact of FreeStyle Libre system use on
acute diabetes events

The RELIEF study¹ has previously shown a reduced hospitalisation rate for diabetic ketoacidosis (DKA) in people with
type 1 diabetes (T1D) or type 2 diabetes (T2D) in the 12 months after initiation of the FreeStyle Libre system in France.

Study objective

The extended analysis of the RELIEF outcomes aimed to evaluate in a real-world setting the persistent long-term clinical
outcomes of using the FreeStyle Libre system in people with T1D or T2D.

Study design & study population

The 2-year RELIEF study follow-up was published by Riveline and colleagues in the expert journal Diabetes Technology & Therapeutics. It provides new insights into the frequency of hospitalisation for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) and severe hypoglycaemia, during use of the FreeStyle Libre (FSL) system.²

The longitudinal retrospective cohort study RELIEF included 31,446 T1D and 41,027 T2D patients with a first delivery of the FreeStyle Libre system between August 1 and December 31, 2017.¹ Hospitalisations for DKA, severe hypoglycaemia, diabetes-related coma and hyperglycaemia were recorded for the 12 months prior to and 24 months after FreeStyle Libre system initiation. Continous and consistent use of the FreeStyle Libre system use was also recorded. Change in usual blood glucose monitoring was estimated through the acquisition of blood glucose test strips.²

Long-term reduction in hospitalisation rates for DKA in T1D and T2D with the FreeStyle Libre system

Reduction in hospitalisation rates for ADE in T1D by 49 % after 2 years

Reduction in hospitalisation rates for ADE in T2D by 48% after 2 years

Persistence with the FSL system 88% after 2 years

Reduction of consumed blood glucose test strips by 82% and 84% in T1D and T2D, respectively, after 2 years

About the RELIEF study follow-up¹

The RELIEF study was conducted as a longitudinal retrospective cohort study.
Data source was the French nationwide reimbursement claim database SNDS between January 1 2015 and December 31 2019.
The overall study was conducted on people with diabetes who initiated the FreeStyle Libre system between August 1 2017 and December 31 2017, such that their use of the system would extend to 24 months by December 2019
Data on hospitalisations for DKA were recorded using ICD-10 code E10.1 (T1D) and E11.1 (T2D) as the main or related diagnosis.
Hospitalisations for severe hypoglycaemia were recorded using ICD-10 codes, E16.0 (drug-induced hypoglycaemia without coma), E16.1 (other hypoglycaemia), E16.2 (hypoglycaemia, unspecified), and T38.3 (poisoning by adverse effects of insulin and oral hypoglycaemic [antidiabetic] drugs). Hospitalisations for diabetes-related comas were identified with ICD-10 codes E10.0 (T1D), E11.0 (T2D), and E14.0 (diabetes unspecified with coma), and hyperglycaemia related stays using ICD-10 code R739 (hyperglycaemia, unspecified).
31,446 people with T1D and 41,027 people with T2D initiating the FreeStyle Libre system during the study period (01/08/2017 to 31/12/2017) were identified. Patients of all ages were included and were not stratified by age.
Circa two-thirds of FreeStyle Libre users with T1D were on multiple daily injection (MDI) therapy and the remainder on insulin pump therapy. Circa two-thirds of FreeStyle Libre users with T2D were on MDI therapy and 18.7 % on CSII, 7.5% on basal insulin only and 7.7% on noninsulin therapies.
Persistence with use of the FreeStyle Libre system was defined between first delivery of a FreeStyle Libre sensor and discontinuation of the FreeStyle Libre system. Discontinuation was assumed when no sensors were delivered to the patient over a consecutive 6-month period.
Blood test strip usage was determined based on reimbursement from 12 months prior to FreeStyle Libre system initiation.

Study results

Key patient baseline characteristics

Table 1 - Main characteristics of patients starting with the FreeStyle Libre system from August 1 2017

Reduced incidence of hospitalisation for ADEs in patients using the FreeStyle Libre system¹

Incidence of diabetic ketoacidosis were reduced after FreeStyle Libre system initiation in T1D and T2D.
The reduction in hospitalisation rates for DKA in T1D was 49%.
The overall reduction for ADEs requiring in hospitalisation in T1D was 42%.
The reduction in hospitalisation rates for DKA in T2D was 48%.
The overall reduction for ADEs requiring in hospitalisation in T2D was 40%.
The rate of patients persisting with the FreeStyle Libre system after 2 years was 88%. The majority (10%) of the discontinuations occurred within the first 6 months of starting with the FreeStyle Libre system.
Two years after starting the FreeStyle Libre system, 68.2% of T1D patients and 74.6% of T2D patients were not using SMBG test strips. The estimated average strip use had fallen to 0.7 per day in T1D and 0.5 in T2D, which equates to reductions of 82% and 84%, respectively, as compared with the year before the FreeStyle Libre system initiation.

Annual percentage of patients with hospital admission for ADEs before and after initiation of the FSL system in patients with T1D (A) and T2D (B). *P= 0.01 for change in admissions for all acute ADEs from year 1 to year 2 for people living with T1DM; **P= 0.007 for change in admissions for all acute ADEs from year 1 to year 2 for people living with T2DM; ***P= 0.0003 for change in admissions for hypoglycaemia from year 1 to year 2 for people living with T2DM.

Summary

The use of the FreeStyle Libre system consistently reduces the rates of hospitalisation for ADEs, mainly DKA, both in T1D and T2D patients 2 years after initiation. The data confirm that this is not a transitory effect. The rate of patients who continuously and consistently used the FreeStyle Libre system after 2 years is high, indicating a high satisfaction with the FreeStyle Libre system. Use of the FreeStyle Libre system also results in a pronounced drop in use of blood glucose test strips over the 2-year period.

The data from this study was collected using the FreeStyle Libre system. The FreeStyle Libre 2 and FreeStyle Libre 3 systems have the same features as the FreeStyle Libre system with real-time glucose alerts. Therefore, the study data are applicable to both products.

References & Disclaimers

Images are for illustrative purposes only.

1. Roussel R et al. Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or Type 2 Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care 2021; 44(6):1368–76.

2. Riveline J-P, et al. Reduced Rate of Acute Diabetes Events with Flash Glucose Monitoring Is Sustained for 2 Years After Initiation: Extended Outcomes from the RELIEF Study. Diabetes Technol Ther. 2022;24(9): 611-618.

Abbreviations

MDI, multiple daily insulin injections; SNDS= Système National des Données de Santé

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RELIEF study follow-up

Long-term reduction of hospitalisation for ketoacidosis