Ketoacidosis Rate Reduced Dramatically after Initiation of Sensor-Based Glucose Monitoring
Presenter: Ronan Roussel, MD, PhD
A dramatic reduction in the rate of ketoacidosis-related hospitalizations occurred in France in patients with type 1 or type 2 diabetes who started using a sensor-based glucose monitoring system (FreeStyle Libre), especially among those patients who previously reported a very low rate of self-monitoring of blood glucose.
The retrospective study, known as RELIEF, is the largest study to date on the impact of the FreeStyle Libre system on rates of hospitalization for diabetic ketoacidosis (DKA), said lead investigator Ronan Roussel, MD, PhD, chief of the endocrinology, diabetes, and nutrition department at Hôpital Bichat, Fédération de Diabétologie, AP-HP, Paris.
“We think that it is plausible that the use of the FreeStyle Libre system allowed, due to its convenience, people to detect and limit persistent hyperglycemia, and subsequently limit the occurrence of ketoacidosis,” he said. “This analysis has significant implications for patient-centered clinical care in diabetes and also for long-term health economic outcomes in the treatment of diabetes at a national level.”
Recent analysis of the Nationwide Emergency Department Sample and National Inpatient Sample from 2006 to 2015 shows that the rates of DKA and hospital admissions for hyperglycemic crises are increasing in the U.S. DKA is generally preventable through close glucose monitoring.
“This is a clinical issue but also the increased burden of hospitalization is associated with significant health care utilization and expenditure in several countries,” said Dr. Roussel.
The Freestyle Libre continuous glucose monitoring system is designed to overcome the pain and inconvenience associated with both strip and sensor-based glucose monitoring. Its use has been reimbursed in France since mid-2017 for patients requiring multiple daily insulin injections.
The investigators used the French national claims database to examine the risk of hospitalization related to DKA before and after access to the FreeStyle Libre system in France in patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM). The study included 74,076 patients who used the system between August 1, 2017, and December 31, 2017, and who had 1 full year of follow-up.
Eligible patients were then classified according to their use of self-monitoring blood glucose (SMBG) test strips in the 12 months before initiation of FreeStyle Libre.
The hospitalization rate for DKA fell by 52% among the cohort with T1DM and by 47% in the cohort with T2DM following initiation of FreeStyle Libre compared with the 12 months prior to initiation. The reduction was most marked in the subpopulation of patients who were not compliant with SMBG in the year prior to the FreeStyle Libre system—a 60% reduction for patients with T1DM and a 51% reduction for patients with T2DM. Patients with the most frequent use of SMBG testing (≥ 5 blood glucose test strips reimbursed per day) also experienced marked reductions in hospitalizations (59% for T1DM and 52% for T2DM).
The reduction in DKA-associated hospitalization rates was observed in patients treated with multiple daily injections (rates: 2.58% in the 12 months before FreeStyle Libre initiation vs. 1.8% in the 12 months after initiation) as well as those who were treated with continuous subcutaneous insulin infusion (2.89% vs. 1.32%).
A health economic analysis from this study will be reported in the future, said Dr. Roussel.
Ronan Roussel, MD, PhD, disclosed advisory panel fees from Abbott, AstraZeneca, Diabnext, Eli Lilly and Company, Merck & Co., Inc., Mundipharma International, Novo Nordisk A/S, and Sanofi-Aventis.