An interventional study of Medtronic 780G System and Continuous Glucose Monitoring in Chronic Kidney Diseases and Diabetes Mellitus, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
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.
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
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 12 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Medtronic 780G System
Device: Continuous Glucose Monitoring
Automated insulin delivery using Medtronic 780G system
Usual care with continuous glucose monitoring
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.
Time frame: 3 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 weeks
Mean sensor glucose
Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage
Time frame: 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
Time frame: 3 weeks
The Diabetes Treatment Satisfaction Questionnaire status
The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care
Time frame: 8 weeks
Hypoglycaemia Fear Survey
Hypoglycaemia Fear Survey with AID versus Usual Care
Time frame: 8 weeks
EQ-5D-5L
EQ-5D-5L with AID versus Usual Care
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Plan to share: No — No plans to share IPD
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Imperial College London