Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Hemodialysis Clinical Trial

— CONDOR  

Official title:

Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509881
• Other study ID #: 1668
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Connie Rhee
• Phone: 714-456-5142
• Email: crhee1[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabete Mellitus
• Diabetes Mellitus
• Hemodialysis

Intervention

Device:
• Continuous glucose monitoring (CGM)
Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.
• Usual care (Self-monitored blood glucose)
Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous glucose monitoring compliance during the intervention period	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	12 weeks
Other	Participant feedback on continuous glucose monitoring training sessions	Survey graded on a 5-point Likert scale; participants' qualitative feedback	12 weeks
Primary	Percent (%) of time in target glucose range (70-180 mg/dl)	Ascertained by continous glucose monitoring	12 weeks
Secondary	Percent (%) of time spent in hypoglycemia (<70 mg/dl)	Ascertained by continous glucose monitoring	12 weeks
Secondary	Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)	Ascertained by continous glucose monitoring	12 weeks
Secondary	Glycemic variability	Ascertained by continous glucose monitoring	12 weeks
Secondary	Hemoglobin A1c level	Ascertained by blood test	12 weeks
Secondary	Fructosamine level	Ascertained by blood test	12 weeks
Secondary	Glycated albumin level	Ascertained by blood test	12 weeks
Secondary	Short Form 36 Survey Physical Component Summary Score	Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life	12 weeks
Secondary	Diabetes Distress Scale Survey Score	Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress	12 weeks
Secondary	Hypoglycemia Fear	Ascertained by Hypoglycemia Fear Survey II	12 weeks