Automated Insulin Delivery in Adults With Advanced Kidney Disease (AIDkidney)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Chronic Kidney Diseases
• Intervention / Treatment: Device: Medtronic 780G System; Device: Continuous Glucose Monitoring

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lalantha Leelarathna, FRCP PhD; Phone Number: +447984477771; Email: e.leelarathna@imperial.ac.uk
• Study Contact Backup: Name: Nick Oliver, FRCP PhD; Email: nick.oliver@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, M13 9WL
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Lalantha Leelarathna, PhD FRCP; Phone Number: +447984477771; Email: e.leelarathna@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age 18-70 years inclusive
• 2. 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)
• 3. The HbA1c <10.5% (<91 mmol/mol)
• 4. The total daily dose of insulin <200Units
• 5. The participant is willing and able to implement the study requirements.
• 6. 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
• 7. Participants (and carer where applicable) should be able to speak and understand English sufficiently for safe study conduct
• 8. The participant has internet or smartphone access, enabling upload of the 780G system data to cloud-based software

Exclusion Criteria:

• 1. The participant is already using an AID system
• 2. 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
• 3. The participant has a recent history of diabetic ketoacidosis (<6 months)
• 4. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for >8 weeks permitted)
• 5. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
• 6. Known significant allergy to tape/ adhesives
• 7. Women who are pregnant or planning pregnancy
• 8. The participant has an active major life-threatening illness limiting the participants life expectancy to <6 months
• 9. The participant is on hydroxyurea treatment or taking regular / daily paracetamol treatment (sensor interference)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated insulin delivery using Medtronic 780G System	Device: Medtronic 780G System; Automated insulin delivery using Medtronic 780G system
Other: Usual care plus continuous glucose monitoring	Device: Continuous Glucose Monitoring; Usual care with continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent time in sensor glucose target range (<3.0 mmol/L)	Percent time in sensor glucose target range (<3.0 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (<3.9 mmol/L)	Percent time in sensor glucose target range (<3.9 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (>10 mmol/L)	Percent time in sensor glucose target range (<10 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (<2.8 mmol/L)	Percent time in sensor glucose target range (<2.8 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (<3.3 mmol/L)	Percent time in sensor glucose target range (<3.3 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (>13.9 mmol/L)	Percent time in sensor glucose target range (<13.9 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (>16.7 mmol/L)	Percent time in sensor glucose target range (<16.7 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Percent time in sensor glucose target range (3.9-7.8 mmol/L)	Percent time in sensor glucose target range (3.9-7.8 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Mean sensor glucose	Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
Standard deviation and coefficient of variation of sensor glucose	Standard deviation and coefficient of variation of sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage	3 weeks
The Diabetes Treatment Satisfaction Questionnaire status	The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care	8 weeks
Hypoglycaemia Fear Survey	Hypoglycaemia Fear Survey with AID versus Usual Care	8 weeks
EQ-5D-5L	EQ-5D-5L with AID versus Usual Care	8 weeks
Episodes of CGM time in <3.0mmol/L range lasting >15minutes	Episodes of CGM time in <3.0mmol/L range lasting >15minutes with AID versus Usual Care	3 weeks
Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia	Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia with AID versus Usual Care	8 weeks
Number of hospitalised and non-hospitalised patients with severe hypoglycaemia	Number of hospitalised and non-hospitalised patients with severe hypoglycaemia with AID versus Usual Care	8 weeks

Collaborators and Investigators

• Sponsor: Imperial College London

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Dialysis; Chronic Kidney Diseases; Automated Insulin Delivery
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Insulin Resistance; Renal Insufficiency, Chronic; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drug Therapy; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Drug Delivery Systems; Continuous Glucose Monitoring
• Other Study ID Numbers: 24HH8885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No