Summary

Summary

  • 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.

  • Key uncertainties around the evidence or technology are that the studies were done in the US. This means generalisability to the NHS may be limited.

  • Safety issues identified are a Medicines and Healthcare products Regulatory Agency Medical Device Alert for faulty mains power adaptors. The users of the affected pumps were identified, and adaptors replaced.

  • The cost of t:slim X2 insulin pump is £3,150 to £3,350 per unit with a cost of £1,588 per year for consumables (excluding VAT).