Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California, Irvine
RECRUITING
Orange
Contact Information
Primary
Connie Rhee
crhee1@uci.edu
714-456-5142
Backup
Kamyar Kalantar-Zadeh
kkz@uci.edu
714-456-5142
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 122
Treatments
Experimental: Continuous glucose monitoring (CGM) arm
During the intervention period, patients in the CGM arm will undergo continuous real-time unblinded CGM using Dexcom CGM devices.
Active_comparator: Usual care arm
During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of California, Irvine