Automated Insulin Delivery in Adults With Advanced Kidney Disease

Last updated: January 6, 2026
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Hormone Deficiencies

Diabetes (Pediatric)

Treatment

Continuous Glucose Monitoring

Medtronic 780G System

Clinical Study ID

NCT06463483
24HH8885
  • Ages 18-70
  • All Genders

Study 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.

There are currently 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. Investigators 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. Investigators will carefully monitor the safety of participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age 18-70 years inclusive
    1. Type 1 diabetes of at least 1-year duration or insulin-requiring type 2 diabetesmanaged with multiple daily injections (MDI [ie separate rapid-acting and basalinsulin injections]) or insulin pump therapy (CSII)
    1. The HbA1c <10.5% (<91 mmol/mol)
    1. The total daily dose of insulin <200Units
    1. The participant is willing and able to implement the study requirements.
    1. Participant has advanced renal disease (Group A: Stage 3b or greater renalfailure (eGFR <45millilitres/minute/1.73m2); Group B: ESKD requiring peritonealdialysis; Group C: ESKD requiring haemodialysis
    1. Participants (and carer where applicable) should be able to speak and understandEnglish sufficiently for safe study conduct
    1. The participant has internet or smartphone access, enabling upload of the 780Gsystem data to cloud-based software

Exclusion

Exclusion Criteria:

    1. The participant is already using an AID system
    1. The participant is treated with sulphonylureas (SGLT2 inhibitors, metformin, andGLP1 analogues may be used within regulatory guidelines) in pre-dialysisparticipants (Group A). In Groups B & C, noninsulin glucose-lowering therapies arenot permitted, with the exception of GLP1 agonists used in preparation fortransplantation
    1. The participant has a recent history of diabetic ketoacidosis (<6 months)
    1. The use of systemic steroid therapy within the past four weeks (stable doses ofsteroids for >8 weeks permitted)
    1. The participant has significant cognitive impairment or major psychiatric historyaffecting safe study conduct
    1. Known significant allergy to tape/ adhesives
    1. Women who are pregnant or planning pregnancy
    1. The participant has an active major life-threatening illness limiting theparticipants life expectancy to <6 months
    1. The participant is on hydroxyurea treatment or taking regular / daily paracetamoltreatment (sensor interference)

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Continuous Glucose Monitoring
Phase:
Study Start date:
November 01, 2025
Estimated Completion Date:
February 01, 2027

Study Description

This will be a single-centre, prospective, open-label, two-stage, randomized crossover study comparing automated subcutaneous insulin delivery (AID), also known as Hybrid Closed Loop (HCL) therapy using the 780G system with usual insulin therapy plus continuous glucose monitoring (CGM) in people with type 1 and type 2 diabetes complicated by advanced renal disease and managed with insulin. The study will be conducted at Imperial College Healthcare NHS Trust.

Duration of each treatment arm is 8 weeks

Connect with a study center

  • Imperial College Healthcare NHS Trust

    London 2643743, M13 9WL
    United Kingdom

    Active - Recruiting

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