RecruitingNot ApplicableNCT06463483

Automated Insulin Delivery in Adults With Advanced Kidney Disease

Glucose Control With Medtronic 780G System in Adults With Diabetes and Advanced Renal Disease


Sponsor

Imperial College London

Enrollment

12 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether an automated insulin delivery (closed-loop) system can safely and effectively manage blood sugar in adults with diabetes who also have advanced kidney disease — including people on peritoneal dialysis or hemodialysis. **You may be eligible if...** - You are between 18 and 70 years old with Type 1 diabetes (at least 1 year) or insulin-requiring Type 2 diabetes - Your HbA1c is below 10.5% and your total daily insulin dose is under 200 units - You have advanced kidney disease (Stage 3b or worse), or you are on peritoneal or hemodialysis - You are NOT already using an automated insulin delivery system - You can speak and understand English **You may NOT be eligible if...** - You have had diabetic ketoacidosis in the past 6 months - You have had systemic steroid treatment in the past 4 weeks (unless on a stable dose for over 8 weeks) - You have significant cognitive impairment or psychiatric history affecting safe study conduct - You have a significant allergy to adhesive tape - You are pregnant or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedtronic 780G System

Automated insulin delivery using Medtronic 780G system

DEVICEContinuous Glucose Monitoring

Usual care with continuous glucose monitoring


Locations(1)

Imperial College Healthcare NHS Trust

London, United Kingdom

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NCT06463483


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