At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Medtronic 780G System (device), Continuous Glucose Monitoring (device)
- How long the study runs
- Study runs about 15 months (dates as stated)
- About the drug or intervention
- Medtronic 780G System — device: Automated insulin delivery using Medtronic 780G system · Continuous Glucose Monitoring — device: Usual care with continuous glucose monitoring
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 12
- Started
- 2025-11-01
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney diseases
- • NA - 12 participants
- • Diabetes is the leading cause of kidney failure in the UK
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with chronic kidney diseases
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓1\. Age 18-70 years inclusive
- ✓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.
- ✓7\. Participants (and carer where applicable) should be able to speak and understand English sufficiently for safe...
Who cannot take part
- ✗1\. The participant is already using an AID system
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London M13 9WL, United Kingdom
How to Get in Touch
Lalantha Leelarathna, FRCP PhD
Sponsor contactCONTACT
Nick Oliver, FRCP PhD
Sponsor contactCONTACT
