Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657508
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Continuous Glucose Monitoring in People with Diabetes on Dialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-World Evaluation of Continuous Glucose Monitoring Data in People with Diabetes and End-Stage Renal Disease Receiving Dialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECORD
Brief Summary:
Continuous glucose monitoring is a sensor which monitors glucose levels continuously throughout the day In people with diabetes especially those treated with insulin this sensor helps guide the amount of treatment such as insulin required to maintain glucose within target
In dialysis the glucose levels and insulin needs can change a lot because of the kidney failure and dialysis treatments
The goal of this observational study is to describe the changes in glucose during and in between dialysis sessions over two weeks by using continuous glucose monitoring The study will also explore whether there is a relationship between the trend of the glucose and fluid level changes during and in between dialysis treatments Also the study will assess whether there is a relationship between glucose levels and several long-term outcomes such as admissions to the hospital for up to five years
In dialysis the glucose levels and insulin needs can change a lot because of the kidney failure and dialysis treatments
The goal of this observational study is to describe the changes in glucose during and in between dialysis sessions over two weeks by using continuous glucose monitoring The study will also explore whether there is a relationship between the trend of the glucose and fluid level changes during and in between dialysis treatments Also the study will assess whether there is a relationship between glucose levels and several long-term outcomes such as admissions to the hospital for up to five years
Detailed Description:
This is a single-centre observational prospective study which involves existing users of NHS funded continuous glucose monitoring CGM with insulin-treated diabetes mellitus DM and end-stage renal disease ESRD established on dialysis
CGM is the standard of care for glucose monitoring in all people with type 1 DM and specific groups with type 2 DM in the United Kingdom
The study aims to evaluate the association between glucose levels in people with diabetes who are on dialysis with short- and long-term clinical outcomes
The study will address the following hypotheses
1 Dialysis causes fluctuation in CGM glucometrics during dialysis and in between dialysis periods
2 Dysglycaemia is associated with adverse short- and long-term outcomes in people with diabetes who are on dialysis
The primary objective of the study is to describe glucose levels in the intradialytic and interdialytic periods by accessing CGM-derived glucometrics over 2 weeks
The secondary objectives of the study are as follows
Short term outcomes
To understand the impact of dialysis on CGM glucometrics in intradialytic and interdialytic periods maintenance haemodialysis or peritoneal dialysis by using raw glucose data combined across multiple different sensors
To investigate the association of glycaemic control CGM data and HbA1c with
Ultrafiltration volume assessed via body weight change in the intradialytic period
Body composition assessed by bioelectrical impedance analysis
Blood pressure
Long term outcomes
To investigate the association of CGM metrics intradialytic and interdialytic periods and 14- and 90-day data and HbA1c with long term outcomes up to 5 years
Mortality
Hospital admissions
Cardiovascular events acute myocardial infarction stroke acute or decompensated heart failure
New diabetic foot ulcer or peripheral vascular disease requiring intervention or amputations
To compare CGM measures with HbA1c as a predictor of long-term outcomes as described above
CGM is the standard of care for glucose monitoring in all people with type 1 DM and specific groups with type 2 DM in the United Kingdom
The study aims to evaluate the association between glucose levels in people with diabetes who are on dialysis with short- and long-term clinical outcomes
The study will address the following hypotheses
1 Dialysis causes fluctuation in CGM glucometrics during dialysis and in between dialysis periods
2 Dysglycaemia is associated with adverse short- and long-term outcomes in people with diabetes who are on dialysis
The primary objective of the study is to describe glucose levels in the intradialytic and interdialytic periods by accessing CGM-derived glucometrics over 2 weeks
The secondary objectives of the study are as follows
Short term outcomes
To understand the impact of dialysis on CGM glucometrics in intradialytic and interdialytic periods maintenance haemodialysis or peritoneal dialysis by using raw glucose data combined across multiple different sensors
To investigate the association of glycaemic control CGM data and HbA1c with
Ultrafiltration volume assessed via body weight change in the intradialytic period
Body composition assessed by bioelectrical impedance analysis
Blood pressure
Long term outcomes
To investigate the association of CGM metrics intradialytic and interdialytic periods and 14- and 90-day data and HbA1c with long term outcomes up to 5 years
Mortality
Hospital admissions
Cardiovascular events acute myocardial infarction stroke acute or decompensated heart failure
New diabetic foot ulcer or peripheral vascular disease requiring intervention or amputations
To compare CGM measures with HbA1c as a predictor of long-term outcomes as described above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None