Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemodialysis
- Sponsor
- University of California, Irvine
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Percent (%) of time in target glucose range (70-180 mg/dl)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
This is a parallel, two-arm randomized controlled trial comparing real-time CGM using Dexcom devices vs. usual care (self-monitored blood glucose 4-times/day) among 122 in-center hemodialysis patients with diabetes mellitus over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients.
Investigators
Connie Rhee
Professor of Medicine
University of California, Irvine
Eligibility 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
Outcomes
Primary Outcomes
Percent (%) of time in target glucose range (70-180 mg/dl)
Time Frame: 12 weeks
Ascertained by continous glucose monitoring
Secondary Outcomes
- Percent (%) of time spent in hypoglycemia (<70 mg/dl)(12 weeks)
- Glycemic variability(12 weeks)
- Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)(12 weeks)
- Hemoglobin A1c level(12 weeks)
- Glycated albumin level(12 weeks)
- Diabetes Distress Scale Survey Score(12 weeks)
- Fructosamine level(12 weeks)
- Short Form 36 Survey Physical Component Summary Score(12 weeks)
- Hypoglycemia Fear(12 weeks)