Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

NCT05509881 | Recruiting DMC

• 1 other identifier: 1668
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Diabete Mellitus; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Percent (%) of time in target glucose range (70-180 mg/dl)

  Ascertained by continous glucose monitoring

  12 weeks

Secondary Outcomes (9)

• Percent (%) of time spent in hypoglycemia (<70 mg/dl)

  12 weeks

• Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)

  12 weeks

• Glycemic variability

  12 weeks

• Hemoglobin A1c level

  12 weeks

• Fructosamine level

  12 weeks

Other Outcomes (2)

• Continuous glucose monitoring compliance during the intervention period

  12 weeks

• Participant feedback on continuous glucose monitoring training sessions

  12 weeks

Study Arms (2)

Continuous glucose monitoring (CGM) arm

EXPERIMENTAL

During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

Device: Continuous glucose monitoring (CGM)

Usual care arm

ACTIVE COMPARATOR

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.

Device: Usual care (Self-monitored blood glucose)

Interventions

Continuous glucose monitoring (CGM) DEVICE

Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

Continuous glucose monitoring (CGM) arm

Usual care (Self-monitored blood glucose) DEVICE

Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.

Usual care arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 34750332 BACKGROUND

• 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.

  PMID: 34378258 BACKGROUND

• 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.

  PMID: 34140100 BACKGROUND

• 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.

  PMID: 30037725 BACKGROUND

• 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.

  PMID: 28592525 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Connie Rhee

CONTACT

714-456-5142; crhee1@uci.edu

Kamyar Kalantar-Zadeh

CONTACT

714-456-5142; kkz@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 22, 2022
• Study Start: December 12, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)