Recruiting

Continuous Glucose Monitoring

Sponsor:

UCLA

Code:

NCT05509881

Conditions

Hemodialysis

Diabete Mellitus

Continuous Glucose Monitoring

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Continuous glucose monitoring (CGM)

Usual care (Self-monitored blood glucose)

Study Details

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

Study ID

NCT05509881

Start date

Dec 12, 2023

Status verified date

Feb, 2024

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Continuous glucose monitoring (CGM) arm

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

active comparator: Usual care arm

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.

Interventions

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.

Primary outcome measure

  • Percent (%) of time in target glucose range (70-180 mg/dl) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Connie Rhee

714-456-5142crhee1@uci.edu

Kamyar Kalantar-Zadeh

714-456-5142kkz@uci.edu

Locations

University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Connie Rhee

312-420-8474crhee@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2024-02-28.