NICE, National Institute for Health and Care Excellence, Englands motsvarig till Läkemedelsverket har gjort en 16-sidors utvärdering inklusive summary av publixcerade studier, a medtech innovation brieifing (MIB) av on t:slim X2 insulin pump for managing blood glucose levels in type 1 diabetes.
Den finns som pdf utan lösenord.
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Utdrag ur sammanfattningen
- The technology described in this briefing is the t:slim X2 insulin pump. It is used for managing blood glucose levels in type 1 diabetes.
- The innovative aspects are using advanced algorithms with a continuous glucose monitor to predict low glucose and suspend insulin delivery. The technology software, Control‑IQ, can also adjust basal insulin and give correction doses.
- The intended place in therapy would be as an alternative to other sensor-augmented insulin pumps for people with type 1 diabetes.
- The main points from the evidence summarised in this briefing are from 6 studies (including 4 randomised controlled trials, 1 randomised crossover study and 1 retrospective study). They included a total of 6,622 patients in a home setting. The studies show that the t:slim X2 insulin pump, with predictive low-glucose suspend technology or advanced hybrid closed-loop system, is more effective than comparators.
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