Overview
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.
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.
Eligibility
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