Continuous Glucose Monitoring in Dialysis Patients With Diabetes (NCT06641765) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Continuous Glucose Monitoring in Dialysis Patients With Diabetes
Denmark96 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups.