Continuous Glucose Monitoring in Dialysis Patients With Diabetes

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

Eligibility

Primary outcome measure(s)

• Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups. — 9 Months
  Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9.

Trial sites (5)

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