Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)

BMJ Open Diabetes Res Care. 2019 Dec 9;7(1):e000809. doi: 10.1136/bmjdrc-2019-000809. eCollection 2019.

Abstract

Introduction: The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.

Methods: Prospective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.

Results: 1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of -4 (95% CI -6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: -9 (95% CI -12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.

Conclusions: Real world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control.

Keywords: continuous glucose monitoring; flash glucose monitoring; freestyle libre; patient reported outcome measures; type 1 diabetes.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomarkers / blood*
  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring / methods*
  • Blood Glucose Self-Monitoring / statistics & numerical data*
  • Diabetes Mellitus, Type 1 / blood*
  • Diabetes Mellitus, Type 1 / drug therapy
  • Diabetes Mellitus, Type 1 / pathology
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetes Mellitus, Type 2 / pathology
  • Female
  • Follow-Up Studies
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemia / prevention & control
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures
  • Prognosis
  • Prospective Studies
  • Quality of Life*

Substances

  • Biomarkers
  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • hemoglobin A1c protein, human