Automated insulin delivery for adults with advanced kidney disease.

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

This tries an automated insulin delivery system (Medtronic 780G) with continuous glucose monitoring in adults with type 1 or insulin-treated type 2 diabetes and advanced kidney disease to see if it improves glucose control and quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Imperial College London (other)
• Locations: 1 site (London)
• Trial ID: NCT06463483 on ClinicalTrials.gov

What this trial studies

This single-centre, prospective, open-label, two-stage randomized crossover study at Imperial College Healthcare NHS Trust compares automated subcutaneous insulin delivery using the Medtronic 780G system with participants' usual insulin therapy combined with continuous glucose monitoring. Adults aged 18–70 with type 1 diabetes or insulin-requiring type 2 diabetes and advanced renal disease (eGFR <45 mL/min/1.73 m2 or on peritoneal or haemodialysis) will be randomized to two 8-week treatment periods with crossover between arms. The trial will collect continuous glucose metrics (including time-in-range and hypoglycaemia rates), patient-reported quality of life and device usability data, and safety outcomes. Device data will be uploaded to cloud-based software and compared between the AID and standard-care periods.

Who should consider this trial

Good fit: Adults 18–70 with type 1 diabetes or insulin-requiring type 2 diabetes who use multiple daily injections or pumps, have advanced renal disease (eGFR <45 mL/min/1.73 m2 or require dialysis), HbA1c below 10.5%, total daily insulin <200 units, and access to a smartphone/internet and English language support.

Not a fit: People already using an automated insulin delivery system, with very high insulin requirements (>200 units/day), unable to use CGM/smartphone technology, or without sufficient English may not benefit from joining this protocol.

Why it matters

Potential benefit: If successful, the system could increase time-in-range, reduce unsafe low glucose episodes, and make diabetes management easier for people with advanced kidney disease.

How similar studies have performed: Automated insulin delivery systems like the 780G have improved glucose control and reduced hypoglycaemia in many studies of people with type 1 diabetes, but there is limited published evidence in insulin-treated type 2 diabetes and in people with advanced kidney disease on dialysis.

Eligibility criteria

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)

Where this trial is running

London

• Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Lalantha Leelarathna, FRCP PhD

Conditions: Chronic Kidney Diseases, Diabetes Mellitus, Diabetes, Automated Insulin Delivery, Dialysis, Insulin