Using continuous glucose monitoring for diabetes management in dialysis patients
Continuous Glucose Monitoring in Haemodialysis and Peritoneal Dialysis Patients With Type 1 and Type 2 Diabetes
NA · Rigshospitalet, Denmark · NCT06641765
This study is testing whether using continuous glucose monitoring can help people with diabetes who are on dialysis manage their blood sugar better than standard monitoring methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 5 sites (Copenhagen and 4 other locations) |
| Trial ID | NCT06641765 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to evaluate the effectiveness of continuous glucose monitoring (CGM) compared to standard glucose monitoring methods in dialysis patients with type 1 or type 2 diabetes. Participants will be randomly assigned to one of three groups: a control group receiving standard monitoring, a group with intermittent CGM access, and a group with continuous CGM access over a 9-month period. The study will assess glycaemic control, hypoglycaemia incidence, quality of life, and cardiovascular outcomes. Participants will also receive consultations with an endocrinologist for treatment adjustments throughout the study.
Who should consider this trial
Good fit: Ideal candidates include adults with type 1 or type 2 diabetes who are currently undergoing maintenance haemodialysis or peritoneal dialysis.
Not a fit: Patients who are pregnant, have major allergies to adhesives, or are currently using continuous glucose monitoring or insulin pumps may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycaemic control and overall health outcomes for dialysis patients with diabetes.
How similar studies have performed: Previous studies have shown promising results with continuous glucose monitoring in diabetes management, particularly in type 1 diabetes, suggesting potential benefits in this population as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen and 4 other locations
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Herlev Hospital — Herlev, Denmark (NOT_YET_RECRUITING)
- North Zealand Hospital, Hillerød — Hillerød, Denmark (NOT_YET_RECRUITING)
- Holbæk Sygehus — Holbæk, Denmark (NOT_YET_RECRUITING)
- Zealand University Hospital — Roskilde, Denmark (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Tobias Bomholt, MD, PhD — Department of Nephrology, Rigshospitalet, University of Copenhagen
- Study coordinator: Christine LM Olesen, MD
- Email: Christine.Olesen@regionh.dk
- Phone: 21495144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Continuous Glucose Monitoring, Haemodialysis, Peritoneal Dialysis, Hypoglycaemia, Quality of life, Time-in-range