Using continuous glucose monitoring to improve diabetes management in dialysis patients
Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
NA · University of California, Irvine · NCT05509881
This study is testing if using continuous glucose monitoring devices can help people with diabetes who are on dialysis manage their blood sugar better than the usual method of checking it four times a day.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT05509881 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares the effectiveness of continuous glucose monitoring (CGM) using Dexcom devices to usual care, which involves self-monitoring blood glucose four times a day, in hemodialysis patients with diabetes mellitus. Over a 12-week period, the study will assess glycemic control, hypoglycemia risk, and quality of life improvements among 122 participants. The primary focus is on the percentage of time patients maintain glucose levels within the target range, while secondary objectives include evaluating blood-based glycemic markers and patient-reported outcomes. The study also aims to measure the feasibility of CGM implementation and compliance during the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with end-stage kidney disease on hemodialysis and a diagnosis of type 1 or type 2 diabetes who have been actively monitoring their blood glucose.
Not a fit: Patients who are unable to provide informed consent, have limited visual acuity, or have prior experience with CGM may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance glycemic control and quality of life for dialysis patients with diabetes.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring in diabetic populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent * Age ≥18 years old * End-stage kidney disease status receiving in-center hemodialysis ≥4 weeks * Type 1 or type 2 diabetes * Actively performing self-monitored blood glucose (SMBG) testing for ≥4 weeks * ≥70% compliance wearing continuous glucose monitoring (CGM) device during the pre-trial period Exclusion Criteria: * Inability to provide informed consent or comply with the study protocol * Limited visual acuity * Inability to wear CGM device * Prior use of CGM * Active pregnancy or planning a pregnancy
Where this trial is running
Orange, California
- University of California, Irvine — Orange, California, United States (RECRUITING)
Study contacts
- Study coordinator: Connie Rhee
- Email: crhee1@uci.edu
- Phone: 714-456-5142
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: Hemodialysis, Diabete Mellitus, Continuous Glucose Monitoring