Continuous Glucose Monitoring in People With Diabetes on Dialysis (RECORD)

University of Nottingham

Status: Enrolling

Conditions: End-Stage Renal Disease; Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT06657508

24046

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: ≥18 years (no upper age limit)
• People with insulin-treated diabetes who receive NHS funded continuous glucose monitoring as part of their routine clinical care
• Diabetes duration > 6 months
• People with end-stage renal disease established on dialysis (maintenance haemodialysis or peritoneal dialysis)
• Ability to give informed consent

Exclusion criteria

• Participation in other competing studies/clinical trials as determined by the study investigator
• Serious illness or events with life expectancy < 3 months or other significant illness which, in the opinion of the study clinician, precludes involvement