On August 18, 2020, Swedish Medical Technology Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in type 2 diabetes, which now includes FreeStyle Libre 2.
Until March 2020, New Therapy (NT) Council was making recommendations for the use of medical technologies. In 2020 a pilot project for national orderly Introduction of medical technologies became permanent, and the new MTP Council is now responsible for decisions and recommendations within this framework.
The following recommendations were provided for FreeStyle Libre 2:
- FreeStyle Libre 2 can be used if the need cannot be covered with FreeStyle Libre 1. This applies to both type 1 and certain patients with type 2 diabetes, according to the previous recommendation published by the NT Council in 2018
- The MTP Council has not made any assessment regarding the handling of any personal data or for the cloud-based service Libre View that can be connected to the device. Each region must decide for itself
Measurements from FreeStyle Libre 2 can be uploaded to the smartphone via a CE-marked app connected to a cloud-based system for diabetes management (Libre View), which cost is included in the product’s price. It is outlined that there are no significant differences in performance or price between FreeStyle Libre 1 and 2 and no new health economic assessment done. However, due to price adjustments since the NT recommendation was published, the cost-effectiveness of FreeStyle Libre improved from 389,000 SEK to 294,000 SEK / QALY.
The conditions for use FreeStyle Libre in type 2 diabetes patients remain the same - patients must be treated with basal insulin in combination with mealtime insulin and have Hba1c > 70 mmol/mol or recurrent severe hypoglycemia despite efforts to adjust insulin doses.
See the full document in Swedish here.
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