CIP353 ELEVATE

• Research type

  Research Study

• Full title

  Evaluation of the safety and effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system (NMX8) in adults living with type 1 diabetes (ELEVATE)

• IRAS ID

  371810

• Contact name

  Patrik Choudhary

• Contact email

  patrik.choudhary@leicester.ac.uk

• Sponsor organisation

  Medtronic

• Duration of Study in the UK

  1 years, 5 months, 17 days

• Research summary

  This is a pre-market, interventional, prospective, open-label, multi-centre, randomised controlled study. The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.
  The MiniMed NMX8 system being used in this study is investigational because it is not CE marked and is not yet approved for use by the public.
  The study consists of three phases: the Run-in phase, the Study Phase and the Continuation phase. At the end of the Run-in phase, it is determined if the patient is eligible for randomisation. If they are eligible, they will be assigned (randomized) to one of two study groups: During the 6-month study phase, subjects in the Treatment group will use the MiniMed NMX8 system, subjects in the Control group will continue to use the current insulin delivery system. For the duration of the 3-month continuation phase, all enrolled subjects will be using the MiniMed NMX8 system
  

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  26/NW/0133

• Date of REC Opinion

  23 Jun 2026

• REC opinion

  Further Information Favourable Opinion