Clinical trial NCT06657508: Continuous Glucose Monitoring in People With Diabetes on Dialysis
Official title: Real-World Evaluation of Continuous Glucose Monitoring Data in People With Diabetes and End-Stage Renal Disease Receiving Dialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
End-Stage Renal Disease
Keywords: Diabetes mellitus
End-stage renal disease
End-stage kidney disease
Dialysis
Haemodialysis
Peritoneal dialysis
Kidney replacement therapy
Continuous Glucose Monitoring
Glucose fluctuations
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient secondary care setting. The study population involves people living with diabetes and end-stage renal disease on dialysis (as per eligibility criteria) attending the Renal Unit at the University Hospitals of Derby and Burton NHS Foundation Trust.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in continuous glucose monitoring % time in glucose range [3.9-10.0 mmol/l] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
Secondary outcomes:
measure: Change in continuous glucose monitoring % time in tight glucose range [3.9-7.8 mmol/l] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring % time above glucose range, level 1 [10.1-13.9 mmol/L] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring % time above glucose range, level 2 [>13.9 mmol/l] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring % time below glucose range, level 1 [3.0-3.8 mmol/l] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring % time below glucose range, level 2 [<3.0 mmol/l] between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring average glucose between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring % coefficient of variation between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Change in continuous glucose monitoring Glucose management indicator (GMI) between intradialytic and interdialytic periods
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Gold score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Diabetes Distress Scale [DDS-17] score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Problem Areas in Diabetes [PAID] score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Glucose Monitoring Satisfaction Survey [GMSS] score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Hypoglycaemia Fear Survey-Version II Worry scale [HFS-II W] score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Integrated Palliative Outcome Score [IPOS]-renal score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between continuous glucose monitoring metrics and baseline Dialysis Thirst Inventory questionnaire score
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between glucose outcomes and body composition measures on dialysis days assessed by bioelectrical impedance analysis
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between glucose outcomes and ultrafiltration volume during dialysis sessions assessed via body weight changes in the intradialytic period
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Relationship between glucose outcomes and changes in blood pressure in the intradialytic period
timeFrame: From baseline to 2 weeks, over 6 consecutive dialysis sessions
measure: Association between glucose outcomes and mortality
timeFrame: From baseline to 5 years
measure: Association between glucose outcomes and hospital admissions
timeFrame: From baseline to 5 years
measure: Association between glucose outcomes and cardiovascular outcomes
timeFrame: From baseline to 5 years
measure: Association between glucose outcomes and new diabetic foot ulcer requiring intervention or amputation
timeFrame: From baseline to 5 years
measure: Association between glucose outcomes and new peripheral vascular disease requiring intervention or amputation
timeFrame: From baseline to 5 years
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton
Study officials:
References: