Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).

NCT04094064 | Completed Results FDA Device

• 1 other identifier: 190012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Dialysis; Hemodialysis; Diabetes; Continuous Glucose Monitor (CGM)

Outcome Measures

Primary Outcomes (2)

• Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])

  Mean Absolute Relative Difference (MARD) between CGM value and capillary blood glucose (SMBG) performed at home 4 to 7 times per day by the participant for 684 matched pairs.

  From CGM placement to CGM removal (10 days)

• Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)

  Venous blood glucose samples were collected approximately 12 blood samples from the existing hemodialysis (HD) intravenous (IV) line during each (three) HD session the CGM sensor was worn. These blood samples were immediately processed using the i-STAT System. While the goal was to have the subject participate in three hemodialysis sessions, two sessions were acceptable. 624 matched data pairs were analyzed.

  From CGM placement to CGM removal (10 days)

Study Arms (1)

CGM Use while on Hemodialysis Therapy

EXPERIMENTAL

All subjects will use a CGM for 10 days. Subjects will continue their standard of care hemodialysis treatments during the study period.

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

Use of a continuous glucose monitor during study period.

CGM Use while on Hemodialysis Therapy

Eligibility Criteria

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

You may qualify if:

• Ages 18+
• Type 1 diabetes mellitus on intermittent HD thrice weekly OR Type 2 diabetes mellitus on intermittent HD thrice weekly
• Willingness and ability to comply with scheduled visits and study procedures

You may not qualify if:

• Inability to comply with finger stick blood glucoses at least four times daily
• Noncompliant with HD therapies
• Pregnant women

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Meaghan Stumpf, MD

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Villard O, Breton MD, Rao S, Voelmle MK, Fuller MR, Myers HE, McFadden RK, Luke ZS, Wakeman CA, Clancy-Oliveri M, Basu A, Stumpf MM. Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. Diabetes Care. 2022 Jul 7;45(7):1666-1669. doi: 10.2337/dc22-0073.

  PMID: 35485908 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Meaghan Stumpf
• Organization: University of Virginia Center for Diabetes Technology

MMS5CF@hscmail.mcc.virginia.edu

(434) 982-4351

Study Officials

• Meaghan Stumpf, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: February 19, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)