Continuous Glucose Monitoring in People With Diabetes on Dialysis

NCT06657508 | Active Not Recruiting

• 1 other identifier: 24046
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease; Diabetes Mellitus

Keywords

Diabetes mellitus; End-stage renal disease; End-stage kidney disease; Dialysis; Haemodialysis; Peritoneal dialysis; Kidney replacement therapy; Continuous Glucose Monitoring; Glucose fluctuations

Outcome Measures

Primary Outcomes (1)

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

Secondary Outcomes (23)

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

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

  From baseline to 2 weeks, over 6 consecutive dialysis sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University Hospitals of Derby and Burton

Derby, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: December 31, 2024
• Primary Completion: October 28, 2025
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)