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NCT Number: NCT06463483

Automated Insulin Delivery in Adults With Advanced Kidney 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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, M13 9WL, United Kingdom

Location status: Recruiting

Location contact

Lalantha Leelarathna, PhD FRCP

CONTACT

[email protected]

+447984477771

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medtronic 780G System

Device

Automated insulin delivery using Medtronic 780G system

Continuous glucose monitoring

Device

Usual care with continuous glucose monitoring

Primary outcomes

  1. Percent time in sensor glucose target range (3.9-10.0 mmol/L)

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Percent time in sensor glucose target range (<3.0 mmol/L)

    Time frame: 3 weeks

    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

  2. Percent time in sensor glucose target range (<3.9 mmol/L)

    Time frame: 3 weeks

    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

  3. Percent time in sensor glucose target range (>10 mmol/L)

    Time frame: 3 weeks

    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

  4. Percent time in sensor glucose target range (<2.8 mmol/L)

    Time frame: 3 weeks

    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

  5. Percent time in sensor glucose target range (<3.3 mmol/L)

    Time frame: 3 weeks

    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

  6. Percent time in sensor glucose target range (>13.9 mmol/L)

    Time frame: 3 weeks

    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

  7. Percent time in sensor glucose target range (>16.7 mmol/L)

    Time frame: 3 weeks

    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

  8. Percent time in sensor glucose target range (3.9-7.8 mmol/L)

    Time frame: 3 weeks

    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

  9. Mean sensor glucose

    Time frame: 3 weeks

    Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage

  10. Standard deviation and coefficient of variation of sensor glucose

    Time frame: 3 weeks

    Standard deviation and coefficient of variation of sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage

  11. The Diabetes Treatment Satisfaction Questionnaire status

    Time frame: 8 weeks

    The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care

  12. Hypoglycaemia Fear Survey

    Time frame: 8 weeks

    Hypoglycaemia Fear Survey with AID versus Usual Care

  13. EQ-5D-5L

    Time frame: 8 weeks

    EQ-5D-5L with AID versus Usual Care

  14. Episodes of CGM time in <3.0mmol/L range lasting >15minutes

    Time frame: 3 weeks

    Episodes of CGM time in <3.0mmol/L range lasting >15minutes with AID versus Usual Care

  15. Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia

    Time frame: 8 weeks

    Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia with AID versus Usual Care

  16. Number of hospitalised and non-hospitalised patients with severe hypoglycaemia

    Time frame: 8 weeks

    Number of hospitalised and non-hospitalised patients with severe hypoglycaemia with AID versus Usual Care

Study contacts

Contact information is provided by the study sponsor or research team.

Lalantha Leelarathna, FRCP PhD

CONTACT

[email protected]

+447984477771

Nick Oliver, FRCP PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: AIDkidney

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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