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Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia (CONDOR) Trial

Award Number: R01DK132869
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia (CONDOR) Trial - PROJECT SUMMARY/ABSTRACT Diabetes mellitus (DM) is the leading cause of chronic kidney disease (CKD), accounting for ~47% and ~39% of US incident and prevalent end‐stage kidney disease (ESKD) patients, respectively. Our published research has shown that hypoglycemia is a highly prevalent complication associated with higher death risk in diabetic kidney disease (DKD) patients. Diabetic hemodialysis (HD) patients are at heightened risk for hypoglycemia via multiple pathways, including 1) decreased renal gluconeogenesis, 2) impaired metabolism/ clearance of DM medications, 3) co-existing comorbidities, 4) limited in-center HD food access, and 5) intra- dialytic glucose shifts. Given the ill effects of hypoglycemia on the cardiovascular (CV) health (arrhythmia, myocardial ischemia) and psychological well-being (hypoglycemia fear, stress/anxiety) observed in non-CKD studies, and the poor survival of diabetic HD patients (<35% over 5 years) largely due to CV causes, there is an urgent unmet need to identify strategies that mitigate low glycemic complications in this population. One of the major barriers to optimal glycemic control in DKD has been the lack of access to a practical, reliable method for frequent glycemic assessment. In diabetic HD patients, conventional metrics (self- monitored blood glucose [SMBG], HbA1c) are dominantly used despite limitations in accuracy, convenience, and intermittent frequency. In contrast, continuous glucose monitoring (CGM) is a convenient, automated glycemic assessment method that has shown improved glycemic control and reduced hypoglycemia in non- CKD trials. While our pilot data of CGM in HD patients shows strong agreement with gold-standard blood glucose levels and superior identification of hypoglycemia, it remains uncertain as to whether CGM can improve glycemic control, reduce hypoglycemia, optimize patient-reported outcomes in this population. To address this knowledge gap, we propose this Multiple-PI R01 study in which we aim to conduct a parallel, two-arm randomized controlled trial (RCT) comparing real-time CGM using Dexcom G6 devices vs. usual care (SMBG 4-times/day) among 122 in-center HD patients with DM 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. This single- center pilot RCT is the critical first step in determining the feasibility, efficacy, and safety of CGM in diabetic HD patients, and it will provide the requisite preliminary data to inform the framework of future large-scale, multi- center corollary RCT’s with an expanded number of endpoints, participants, and sites.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $208,818 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	3	2/26/2025	NON-COMPETING CONTINUATION	$208,818
2025	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/14/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	2/18/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$304,402
2025	2023	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	2/18/2025	NEW	-$304,402
														Subtotal = $208,818

Issue Date FY: 2024 ( Subtotal = $235,219 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	2	5/15/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$14,701
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	3/15/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$24,502
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10920 WILSHIRE BLVD STE 500	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	3/4/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$245,020
2024	2023	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/1/2024	NEW	$0
														Subtotal = $235,219

Issue Date FY: 2023 ( Subtotal = $314,000 )
2023	2023	UNIVERSITY OF CALIFORNIA, IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/20/2023	NEW	$314,000
														Subtotal = $314,000

Grand Total All Awards = $758,037

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Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia (CONDOR) Trial

Award Number: R01DK132869

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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