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Continuous Glucose Monitoring in Dialysis Patients With Diabetes

NCT06641765 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-27

No results posted yet for this study

Summary

The primary objective of this multicenter, randomized controlled trial is to assess whether the intermittent or continuous use of continous glucose monitoring can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard monitoring involving finger-prick glucose and HbA1c.

Participants will be monitored for 9 months and randomly assigned to one of three groups:

* Group 1, the control group, will undergo standard monitoring (using HbA1c and BGM) along with double-blinded CGM sessions at month 0, 3, 6, and 9.
* Group 2 will have intermittent access to open CGM during the same time intervals.
* Group 3 will have continuous access to open CGM throughout the entire duration of the study.

During the study period, participants will have three consultations with an endocrinologist for adjustments in their glucose-lowering treatment.

The goal is to compare markers of glycaemic control between the three groups. Secondary objectives include evaluating the impact on hypoglycaemia, quality of life, hospitals admissions and cardiovascular events.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
  • Continuous Glucose Monitoring
  • Haemodialysis
  • Peritoneal Dialysis

Interventions

DEVICE

Continous Glucose Monitoring

10 days of real time open access to Continous Glucose Monitoring - either at defined time intervals (Group 2) or continuously for 9 months (Group 3).

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Bo Feldt-Rasmussen

    lead OTHER

Principal Investigators

  • Tobias Bomholt, MD, PhD · Department of Nephrology, Rigshospitalet, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-10-30
Completion
2026-10-30
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641765 on ClinicalTrials.gov