Automated Insulin Delivery in Adults With Advanced Kidney Disease
NCT Number: NCT06463483
Acronym: AIDkidney
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases|Diabetes Mellitus
Interventions: DEVICE: Medtronic 780G System|DEVICE: Continuous Glucose Monitoring
Sponsor: Imperial College London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-02-01

Summary:
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.

Primary Outcome Measures: 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., 3 weeks
Secondary Outcome Measures: 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, 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, 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, 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, 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, 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, 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, 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, 3 weeks|Mean sensor glucose, Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage, 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, 3 weeks|The Diabetes Treatment Satisfaction Questionnaire status, The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care, 8 weeks|Hypoglycaemia Fear Survey, Hypoglycaemia Fear Survey with AID versus Usual Care, 8 weeks|EQ-5D-5L, EQ-5D-5L with AID versus Usual Care, 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, 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, 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, 8 weeks