Continuous Glucose Monitoring, Diabete Mellitus, Hemodialysis
Conditions
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.
Interventions
DEVICEContinuous glucose monitoring (CGM)
Patients in the CGM arm will undergo continuous real-time unblinded CGM using Dexcom CGM devices.
DEVICEUsual care (Self-monitored blood glucose)
Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent (%) of time in target glucose range (70-180 mg/dl) | 12 weeks | Ascertained by continous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent (%) of time spent in hypoglycemia (<70 mg/dl) | 12 weeks | Ascertained by continous glucose monitoring |
| Percent (%) of time spent in relative hypoglycemia (<100 mg/dl) | 12 weeks | Ascertained by continous glucose monitoring |
| Glycemic variability | 12 weeks | Ascertained by continous glucose monitoring |
| Hemoglobin A1c 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 |
| Hypoglycemia Fear | 12 weeks | Ascertained by Hypoglycemia Fear Survey II |
| Glycated albumin level | 12 weeks | Ascertained by blood test |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Continuous glucose monitoring compliance during the intervention period | 12 weeks | CGM compliance will be ascertained by two metrics; 1) wearing the CGM device ≥6 days/week, and 2) % of time CGM is active, which is an automatically captured/reported metric on the Dexcom G6 device |
| Participant feedback on continuous glucose monitoring training sessions | 12 weeks | Survey graded on a 5-point Likert scale; participants' qualitative feedback |
Countries
United States
Contacts
Primary ContactConnie Rhee
Backup ContactKamyar Kalantar-Zadeh
Outcome results
None listed