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Active, Not Recruiting

NCT Number: NCT06657508

Continuous Glucose Monitoring in People With Diabetes on Dialysis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Chronic Disease Disease Attributes End-stage Renal Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Derby and Burton

Derby, United Kingdom

About this study

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:

  • Dialysis causes fluctuation in CGM glucometrics during dialysis and in between dialysis periods.
  • 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in continuous glucose monitoring % time in glucose range [3.9-10.0 mmol/l] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

Secondary outcomes

  1. Change in continuous glucose monitoring % time in tight glucose range [3.9-7.8 mmol/l] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  2. Change in continuous glucose monitoring % time above glucose range, level 1 [10.1-13.9 mmol/L] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  3. Change in continuous glucose monitoring % time above glucose range, level 2 [>13.9 mmol/l] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  4. Change in continuous glucose monitoring % time below glucose range, level 1 [3.0-3.8 mmol/l] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  5. Change in continuous glucose monitoring % time below glucose range, level 2 [<3.0 mmol/l] between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  6. Change in continuous glucose monitoring average glucose between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  7. Change in continuous glucose monitoring % coefficient of variation between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  8. Change in continuous glucose monitoring Glucose management indicator (GMI) between intradialytic and interdialytic periods

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  9. Relationship between continuous glucose monitoring metrics and baseline Gold score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

    The Gold score assesses hypoglycaemia awareness

  10. Relationship between continuous glucose monitoring metrics and baseline Diabetes Distress Scale [DDS-17] score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  11. Relationship between continuous glucose monitoring metrics and baseline Problem Areas in Diabetes [PAID] score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  12. Relationship between continuous glucose monitoring metrics and baseline Glucose Monitoring Satisfaction Survey [GMSS] score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  13. Relationship between continuous glucose monitoring metrics and baseline Hypoglycaemia Fear Survey-Version II Worry scale [HFS-II W] score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  14. Relationship between continuous glucose monitoring metrics and baseline Integrated Palliative Outcome Score [IPOS]-renal score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  15. Relationship between continuous glucose monitoring metrics and baseline Dialysis Thirst Inventory questionnaire score

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

  16. Relationship between glucose outcomes and body composition measures on dialysis days assessed by bioelectrical impedance analysis

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c

  17. Relationship between glucose outcomes and ultrafiltration volume during dialysis sessions assessed via body weight changes in the intradialytic period

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c

  18. Relationship between glucose outcomes and changes in blood pressure in the intradialytic period

    Time frame: From baseline to 2 weeks, over 6 consecutive dialysis sessions

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, intradialytic and interdialytic continuous glucose monitoring metrics, baseline HbA1c.

    Changes in blood pressure are assessed by measuring blood pressure prior to and post dialysis sessions

  19. Association between glucose outcomes and mortality

    Time frame: From baseline to 5 years

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12

  20. Association between glucose outcomes and hospital admissions

    Time frame: From baseline to 5 years

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12

  21. Association between glucose outcomes and cardiovascular outcomes

    Time frame: From baseline to 5 years

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12.

    Cardiovascular outcomes include acute myocardial infarction, stroke, acute or decompensated heart failure

  22. Association between glucose outcomes and new diabetic foot ulcer requiring intervention or amputation

    Time frame: From baseline to 5 years

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12

  23. Association between glucose outcomes and new peripheral vascular disease requiring intervention or amputation

    Time frame: From baseline to 5 years

    Glucose outcomes include 14- and 90- day continuous glucose monitoring metrics at baseline, baseline HbA1c, intradialytic and interdialytic continuous glucose monitoring metrics, 14- and 90- day continuous glucose monitoring metrics and HbA1c at month 3, 6, 9 and 12

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Real-World Evaluation of Continuous Glucose Monitoring Data in People With Diabetes and End-Stage Renal Disease Receiving Dialysis

Acronym: RECORD

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Oct 24, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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