Patients with acute diabetes complications in the subgroups using one to three or four to five SMBG test strips per day showed a significant reduction of −35.2% and −32.2%, respectively, in each case in the year after starting the FreeStyle Libre system ( Fig. A reduction in hospitalizations of −54.0% and −51.2%, respectively, was observed in these two groups.
Both the incidence and the fall in rates of hospitalizations for acute diabetes complications were most marked for the 19,396 people who were not compliant with SMBG testing, as indicated by no consumption of test strips, but also for people with the most regular use of SMBG testing (>5 strips) ( Fig. The assumed average daily frequency of SMBG categories were no strips, 1–3 strips, 4–5 strips, >5 strips, as described in Table 1. We analyzed hospitalization rates among study individuals who had been subcategorized based on their assumed average daily frequency of SMBG usage prior to their first FreeStyle Libre sensor use. The data broken down by age and sex of the study population are provided in Supplementary Table 3, and the frequency of events per 1,000 patient-years is presented in Supplementary Table 2. Amongst the whole study population, hospitalizations rates for hypoglycemia and hyperglycemia fell by 6.4% and 13%, respectively, in each case, with a decrease mainly observed in type 2 diabetes (−10.8% and −26.5%) ( Fig. The fall was by 39.6% for type 1 diabetes and by 31.9% for type 2 diabetes ( Fig. Overall, the percentage of patients with at least one hospitalization for a diabetes-related coma fell by 35.7%. A slight but significant decrease was also observed for diabetes-related comas. Hospitalization rates for DKA fell by 55.0%, from 2,508 patients in the year prior to starting FreeStyle Libre to 1,128 in the year after starting (−56.2% and −52.1% ) ( Fig. The fall in DKA hospitalization rates was more marked than for other acute complications in both types of diabetes. Exclusion criteria included the following: patients with only one FreeStyle Libre reader reimbursement without any further reimbursements for FreeStyle Libre sensors over the study period, patients deceased before the first sensor reimbursement, and patients <18 years old without insulin therapy 6 months before and 6 months after FreeStyle Libre initiation.
#FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM EU CLASS II CODE#
1).Īn algorithm was used to define and qualify any patient who used the FreeStyle Libre system as having diabetes only if they had received at least three reimbursements for antidiabetes drugs (oral or insulin) over 1 year or within the 2 years preceding or 1 year after FreeStyle Libre initiation (or at least two reimbursements if one large pack size was dispensed) or, alternatively, if the patient had been hospitalized at least once with a diagnostic ICD-10 code ( 15)-E10 (type 1 diabetes), E11 (type 2 diabetes), or E14 (unspecified diabetes)-or was identified in the French health care system as having a long-standing condition with the same ICD-10 codes during the same period.
We then analyzed SNDS data from these patients over the 12 months prior to their initiation of the FreeStyle Libre system and in the 12 months following initiation ( Fig. These individuals did not purchase FreeStyle Libre sensors or readers between 1 June 2017 and 1 August 2017 and so were considered new users of the FreeStyle Libre system. We chose to consider in our study only individuals with diabetes who initiated the FreeStyle Libre system during the period between 1 August 2017 and 31 December 2017. In our study, initiation of the FreeStyle Libre system was defined as a first reimbursement of sensor or reader in the SNDS over the period after 1 August 2017 without any reimbursement of reader or sensors in the previous months of 2017. Costs for the FreeStyle Libre system have been reimbursed in France since 1 June 2017, but the FreeStyle Libre system was marketed before this date without reimbursement. This longitudinal retrospective cohort study was carried out with use of data extracted from the national French database SNDS covering the period between 1 January 2015 and 31 December 2018.
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