Clinical trial NCT05509881: Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
Official title: Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Diabete Mellitus
Continuous Glucose Monitoring
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent (%) of time in target glucose range (70-180 mg/dl)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent (%) of time spent in hypoglycemia (<70 mg/dl)
timeFrame: 12 weeks
measure: Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)
timeFrame: 12 weeks
measure: Glycemic variability
timeFrame: 12 weeks
measure: Hemoglobin A1c level
timeFrame: 12 weeks
measure: Fructosamine level
timeFrame: 12 weeks
measure: Glycated albumin level
timeFrame: 12 weeks
measure: Short Form 36 Survey Physical Component Summary Score
timeFrame: 12 weeks
measure: Diabetes Distress Scale Survey Score
timeFrame: 12 weeks
measure: Hypoglycemia Fear
timeFrame: 12 weeks
Other outcomes:
measure: Continuous glucose monitoring compliance during the intervention period
timeFrame: 12 weeks
measure: Participant feedback on continuous glucose monitoring training sessions
timeFrame: 12 weeks
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
References:
citation: Rhee CM, Kalantar-Zadeh K, Tuttle KR. Novel approaches to hypoglycemia and burnt-out diabetes in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Jan 1;31(1):72-81. doi: 10.1097/MNH.0000000000000756.
citation: Narasaki Y, Park E, You AS, Daza A, Peralta RA, Guerrero Y, Novoa A, Amin AN, Nguyen DV, Price D, Kalantar-Zadeh K, Rhee CM. Continuous glucose monitoring in an end-stage renal disease patient with diabetes receiving hemodialysis. Semin Dial. 2021 Sep;34(5):388-393. doi: 10.1111/sdi.13009. Epub 2021 Aug 10.
citation: Rhee CM, Kovesdy CP, Kalantar-Zadeh K. Glucose Homeostasis, Hypoglycemia, and the Burnt-Out Diabetes Phenomenon in Kidney Disease. Semin Nephrol. 2021 Mar;41(2):96-103. doi: 10.1016/j.semnephrol.2021.03.004.
citation: Rhee CM, Kovesdy CP, You AS, Sim JJ, Soohoo M, Streja E, Molnar MZ, Amin AN, Abbott K, Nguyen DV, Kalantar-Zadeh K. Hypoglycemia-Related Hospitalizations and Mortality Among Patients With Diabetes Transitioning to Dialysis. Am J Kidney Dis. 2018 Nov;72(5):701-710. doi: 10.1053/j.ajkd.2018.04.022. Epub 2018 Jul 20.
citation: Rhee CM, Kovesdy CP, Ravel VA, Streja E, Brunelli SM, Soohoo M, Sumida K, Molnar MZ, Brent GA, Nguyen DV, Kalantar-Zadeh K. Association of Glycemic Status During Progression of Chronic Kidney Disease With Early Dialysis Mortality in Patients With Diabetes. Diabetes Care. 2017 Aug;40(8):1050-1057. doi: 10.2337/dc17-0110. Epub 2017 Jun 7.