Chronic Kidney DiseasesAIDkidneyNCT06463483
Automated Insulin Delivery in Adults With Advanced Kidney Disease
A study testing Medtronic 780G System and Continuous Glucose Monitoring in people with Chronic Kidney Diseases and Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus
- What is being tested?
- Medtronic 780G System and Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2025to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nick Oliver, FRCP PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, M13 9WL
Lalantha Leelarathna, PhD FRCP, +447984477771, e.leelarathna@imperial.ac.uk
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus
- Being tested
- Medtronic 780G System, Continuous Glucose Monitoring
- Keywords
- Diabetes, Automated Insulin Delivery, Dialysis, Chronic Kidney Diseases, Insulin
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic 780G SystemDevice
Automated insulin delivery using Medtronic 780G system
Continuous Glucose MonitoringDevice
Usual care with continuous glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Automated insulin delivery using Medtronic 780G System | Experimental | Not described Receives: Device: Medtronic 780G System |
| Usual care plus continuous glucose monitoring | Other | Not described Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 weeks
Mean sensor glucose
Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage
Measured: 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
Measured: 3 weeks
The Diabetes Treatment Satisfaction Questionnaire status
The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care
Measured: 8 weeks
Hypoglycaemia Fear Survey
Hypoglycaemia Fear Survey with AID versus Usual Care
Measured: 8 weeks
EQ-5D-5L
EQ-5D-5L with AID versus Usual Care
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463483
- Sponsor's protocol ID
- 24HH8885
- Acronym
- AIDkidney
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Publications
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.
PubMed 34349267Bally 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.
PubMed 31133457Lu 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.
PubMed 37162092