Automated insulin delivery for adults with advanced kidney disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Lalantha Leelarathna, FRCP PhD
• Email: e.leelarathna@imperial.ac.uk
• Phone: +447984477771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.