Automated Insulin Delivery in Adults With Advanced Kidney Disease

NCT06463483 | Recruiting

• 1 other identifier: 24HH8885
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Chronic Kidney Diseases

Keywords

Diabetes; Automated Insulin Delivery; Dialysis; Chronic Kidney Diseases; Insulin

Outcome Measures

Primary Outcomes (1)

• Percent time in sensor glucose target range (3.9-10.0 mmol/L)

  Percent time in sensor glucose target range (3.9-10.0 mmol/L) with Automated Insulin Delivery (AID) versus Usual Care measured during the final 3 weeks of each study stage.

  3 weeks

Secondary Outcomes (16)

• Percent time in sensor glucose target range (<3.0 mmol/L)

  3 weeks

• Percent time in sensor glucose target range (<3.9 mmol/L)

  3 weeks

• Percent time in sensor glucose target range (>10 mmol/L)

  3 weeks

• Percent time in sensor glucose target range (<2.8 mmol/L)

  3 weeks

• Percent time in sensor glucose target range (<3.3 mmol/L)

  3 weeks

Study Arms (2)

Automated insulin delivery using Medtronic 780G System

EXPERIMENTAL

Device: Medtronic 780G System

Usual care plus continuous glucose monitoring

OTHER

Device: Continuous Glucose Monitoring

Interventions

Medtronic 780G System DEVICE

Automated insulin delivery using Medtronic 780G system

Automated insulin delivery using Medtronic 780G System

Continuous Glucose Monitoring DEVICE

Usual care with continuous glucose monitoring

Usual care plus continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. The participant is already using an AID system
• \. The participant is treated with sulphonylureas (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines) in pre-dialysis participants (Group A). In Groups B \& C, noninsulin glucose-lowering therapies are not permitted, with the exception of GLP1 agonists used in preparation for transplantation
• \. The participant has a recent history of diabetic ketoacidosis (\<6 months)
• \. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for \>8 weeks permitted)
• \. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
• \. Known significant allergy to tape/ adhesives
• \. Women who are pregnant or planning pregnancy
• \. The participant has an active major life-threatening illness limiting the participants life expectancy to \<6 months
• \. The participant is on hydroxyurea treatment or taking regular / daily paracetamol treatment (sensor interference)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, M13 9WL, United Kingdom

RECRUITING

Related Publications (3)

• Boughton CK, Tripyla A, Hartnell S, Daly A, Herzig D, Wilinska ME, Czerlau C, Fry A, Bally L, Hovorka R. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nat Med. 2021 Aug;27(8):1471-1476. doi: 10.1038/s41591-021-01453-z. Epub 2021 Aug 4.

  PMID: 34349267 BACKGROUND

• Bally L, Gubler P, Thabit H, Hartnell S, Ruan Y, Wilinska ME, Evans ML, Semmo M, Vogt B, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. 2019 Sep;96(3):593-596. doi: 10.1016/j.kint.2019.03.006. Epub 2019 Mar 20.

  PMID: 31133457 BACKGROUND

• Lu JC, Lee P, Ierino F, MacIsaac RJ, Ekinci E, O'Neal D. Challenges of Glycemic Control in People With Diabetes and Advanced Kidney Disease and the Potential of Automated Insulin Delivery. J Diabetes Sci Technol. 2024 Nov;18(6):1500-1508. doi: 10.1177/19322968231174040. Epub 2023 May 10.

  PMID: 37162092 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Insulin Resistance

Interventions

Drug Delivery Systems; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Lalantha Leelarathna, FRCP PhD

CONTACT

+447984477771; e.leelarathna@imperial.ac.uk

Nick Oliver, FRCP PhD

CONTACT

nick.oliver@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 17, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)