Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463483
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-10
Brief Title:
Automated Insulin Delivery in Adults With Advanced Kidney Disease
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Glucose Control With Medtronic 780G System in Adults With Diabetes and Advanced Renal Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIDkidney
Brief 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 andor 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
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 andor 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
Detailed Description:
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
Duration of each treatment arm is 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None