Flash Glucose Monitoring (FGM)

In this report Zorginstituut Nederland (National Health Care Institute) assesses whether Flash Glucose Monitoring (FGM) complies with ‘established medical science and medical practice’ for five indication groups within the diabetes population, who could be eligible for rt-CGM. The Zorginstituut also assesses whether FGM can be regarded as care that is normally provided by medical specialists, or as care in the form of medical devices.
Due to small adjustments, FGM differs from rt-CGM – which is already regarded as ‘established medical science and medical practice’.

Conclusion

In this report, we establish that the technical accuracy of FGM is comparable with that of rt-CGM. The conclusion is that FGM can be regarded as an effective intervention for the following indications:

  • children with type 1 diabetes;
  • adults with poorly regulated type 1 diabetes (despite standard control, persistently high HbA1c (>8% or >64 mmol/mol));
  • pregnant woman with existing diabetes (types 1 and 2);
  • women who want to get pregnant who have preconception diabetes (types 1 and 2).

For the four indications named, FGM complies with ‘established medical science and medical practice’.

This outcome of assessment comes into effect on 27 November 2017.