NCT06329297

Brief Summary

The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

March 1, 2024

Last Update Submit

April 20, 2026

Conditions

Hyperglycemia

Keywords

continuous glucose monitorCGM

Outcome Measures

Primary Outcomes (1)

  • CGM vs point of care test (POCT) glucose

    Continuous interstitial glucose monitor readings compared to point of care capillary blood glucose readings

    from date of admission up to 7 days

Secondary Outcomes (1)

  • Slow downward trend arrow on CGM device

    from date of admission up to 7 days

Study Arms (2)

Open-heart surgery inpatients

Patients having elective open-heart surgery including coronary artery bypass grafting (CABG), aortic valve repair/replacement (AVR), mitral valve repair/replacement (MVR), or any combination of those will have a CGM monitor placed within one hour of admission for up to 7 days or upon discharge.

Device: CGM monitor

General medical inpatients

Medical inpatients who have a Glucommander order for management of hyperglycemia will have a CGM monitor placed within 24 hours of admission for up to 7 days or upon discharge.

Device: CGM monitor

Interventions

CGM monitorDEVICE

blood glucose sensor used to monitor interstitial glucose

Also known as: Libre 3 Freestyle Continuous Glucose Monitor
General medical inpatientsOpen-heart surgery inpatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients having elective open-heart surgery including coronary artery bypass grafting (CABG), aortic valve repair/replacement (AVR), mitral valve repair/replacement (MVR), or any combination of those and, Medical inpatients who have a Glucommander order for management of hyperglycemia.

You may qualify if:

  • Admitted patients 18 years of age or older
  • Glucose management per Glucommander and/or receiving POC blood glucose testing
  • Patients admitted to Medical 6 or elective or urgent open-heart surgery patients admitted to the Cardiovascular Intensive Care Unit (CVICU)

You may not qualify if:

  • Patients less than 18 years of age
  • Pregnant or currently breastfeeding
  • Prisoners
  • Patients unable to consent in English.
  • Patients with a preexisting insulin pump on admission
  • Active skin infection at the insertion site(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064. doi: 10.1177/1932296820954163. Epub 2020 Sep 28.

    PMID: 32985262BACKGROUND

  • van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel). 2017 Jan 14;17(1):146. doi: 10.3390/s17010146.

    PMID: 28098809BACKGROUND

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jan R Powers

    Parkview Health

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Researcher & Nursing Research Program Coordinator

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 25, 2024

Study Start

October 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share