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Continuous Glucose Monitoring in Dialysis Patients With Diabetes

RECRUITINGN/ASponsored by Bo Feldt-Rasmussen
Actively Recruiting
PhaseN/A
SponsorBo Feldt-Rasmussen
Started2024-11-01
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Written informed consent obtained before any trial-related procedures are performed
* Diabetes, one of the following groups: Type 1 diabetes OR Type 2 diabetes receiving glucose-lowering therapy OR Type 2 diabetes managed with lifestyle changes with an HbA1c ≥ 50 mmol/mol
* Maintenance haemodialysis or peritoneal dialysis (minimum of two weeks)
* Subject must be willing and able to comply with trial protocol and be fluent in Danish or English

Exclusion Criteria:

* Major allergy to tape/adhesives
* Women who are pregnant or planning pregnancy
* Ongoing use of CGM
* Ongoing use of insulin pump

Conditions6

Continuous Glucose MonitoringDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2HaemodialysisPeritoneal Dialysis

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