Automated Insulin Delivery in Advanced Kidney Disease (AIDkidney) 1.0

  • Research type

    Research Study

  • Full title

    Glucose Control with Medtronic 780G Automated Insulin Delivery System in Adults with Diabetes and Advanced Kidney Disease

  • IRAS ID

    342901

  • Contact name

    Lalantha Leelarathna

  • Contact email

    e.leelarathna@imperial.ac.uk

  • Sponsor organisation

    Imperial College London and Imperial College Healthcare NHS Trust

  • Clinicaltrials.gov Identifier

    NCT06463483

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is hard, with fluctuating glucose levels and an increased risk of unsafe low glucose levels.

    We now have continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that deliver insulin automatically to control glucose. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure and on dialysis.

    This study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with diabetes treated with more than one insulin injection with advanced kidney failure and/or undergoing regular dialysis treatment. This study will be a feasibility study conducted in a single centre (Imperial College, London) and be of a cross-over design. The study will aim to complete 12 people. Participants will wear a glucose sensor at the start. In random order, half will start AID followed by the usual treatment, while the other half will start the usual treatment followed by AID treatment. The duration of each treatment stage is eight weeks. The study will last about 22 weeks for each participant. We will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants’ experiences. We will carefully monitor the safety of participants.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    24/LO/0480

  • Date of REC Opinion

    22 Aug 2024

  • REC opinion

    Further Information Favourable Opinion