We are pleased to announce that the joint rapid assessment on “Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin” is available.
The health technologies assessed include rtCGM systems and FGM systems as personal, standalone medical devices for patients with diabetes mellitus type 1 and type 2 (T1DM and T2DM), including adults, children, and patients with gestational DM treated with insulin, either through insulin pump therapy (CSII) or multiple daily insulin injections (MDII). Professional (retrospective) devices are not included in this assessment.
The objective of this rapid assessment was to evaluate the relative effectiveness and safety of real-time continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin. We do not provide any recommendations; this is left to national/regional and local HTA processes, appraisal processes, and decision-making.
The final version of the assessment was published on July 27 2018.
Below is the documentation provided by the assessment authoring team:
OTJA08 Final Assessment HERE
OTJA08 External Expert Comments HERE
OTJA08 Project Plan HERE
OTJA08 Project Plan External Expert and Manufacturer Comments HERE