Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
- Conditions
- Diabete MellitusContinuous Glucose MonitoringHemodialysis
- Interventions
- Device: Continuous glucose monitoring (CGM)Device: Usual care (Self-monitored blood glucose)
- Registration Number
- NCT05509881
- Lead Sponsor
- University of California, Irvine
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous glucose monitoring (CGM) arm Continuous glucose monitoring (CGM) During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices. Usual care arm Usual care (Self-monitored blood glucose) 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.
- Primary Outcome Measures
Name Time Method Percent (%) of time in target glucose range (70-180 mg/dl) 12 weeks Ascertained by continous glucose monitoring
- Secondary Outcome Measures
Name Time Method Short Form 36 Survey Physical Component Summary Score 12 weeks Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life
Hypoglycemia Fear 12 weeks Ascertained by Hypoglycemia Fear Survey II
Percent (%) of time spent in hypoglycemia (<70 mg/dl) 12 weeks Ascertained by continous glucose monitoring
Glycemic variability 12 weeks Ascertained by continous glucose monitoring
Percent (%) of time spent in relative hypoglycemia (<100 mg/dl) 12 weeks Ascertained by continous glucose monitoring
Hemoglobin A1c level 12 weeks Ascertained by blood test
Glycated albumin level 12 weeks Ascertained by blood test
Fructosamine level 12 weeks Ascertained by blood test
Diabetes Distress Scale Survey Score 12 weeks Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress
Trial Locations
- Locations (1)
University of California, Irvine
🇺🇸Orange, California, United States