Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06463483

Automated Insulin Delivery in Adults With Advanced Kidney Disease

Led by Imperial College London · Updated on 2026-01-08

12

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Automated Insulin Delivery in Adults With Advanced Kidney Disease

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years inclusive
  • Type 1 diabetes for at least 1 year or insulin-requiring type 2 diabetes managed with multiple daily injections or insulin pump therapy
  • HbA1c less than 10.5% (less than 91 mmol/mol)
  • Total daily insulin dose less than 200 units
  • Willing and able to follow study requirements
  • Advanced kidney disease: stage 3b or greater renal failure, or end-stage kidney disease requiring peritoneal or hemodialysis
  • Able to speak and understand English sufficiently for safe study participation
  • Access to internet or smartphone to upload Medtronic 780G system data
Not Eligible

You will not qualify if you...

  • Currently using an automated insulin delivery system
  • Use of sulphonylureas in pre-dialysis participants; noninsulin glucose-lowering therapies not allowed in dialysis groups except GLP1 agonists for transplant preparation
  • Recent diabetic ketoacidosis within 6 months
  • Use of systemic steroids within past 4 weeks (stable doses over 8 weeks allowed)
  • Significant cognitive impairment or major psychiatric illness affecting safe participation
  • Known serious allergy to tape or adhesives
  • Pregnant or planning pregnancy
  • Active major life-threatening illness with life expectancy less than 6 months
  • On hydroxyurea or taking regular/daily paracetamol (which may interfere with sensors)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Imperial College Healthcare NHS Trust

London, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

L

Lalantha Leelarathna, FRCP PhD

CONTACT

N

Nick Oliver, FRCP PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Automated Insulin Delivery in Adults With Advanced Kidney Disease | DecenTrialz