NCT07216508

Brief Summary

This investigator initiated study aims to describe continuous glucose monitoring (CGM) based glycemic metrics after discharge from liver transplant and assess relationship with glycemic metrics and liver transplant outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress29%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

October 9, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2027

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

October 9, 2025

Last Update Submit

November 10, 2025

Conditions

Keywords

liver transplanthyperglycemiadiabetescontinuous glucose monitoringglucose sensor

Outcome Measures

Primary Outcomes (1)

  • Time in range

    Time in range 70-180mg/dL

    28 days

Secondary Outcomes (5)

  • Percent time >180mg/dL

    28 days

  • Percent time >250mg/dL

    28 days

  • Percent time <70mg/dL

    28 days

  • Percent time <54mg/dL

    28 days

  • Transplant outcomes

    1 year

Study Arms (1)

Participants post liver transplant

Participants who are discharged from after liver transplant.

Device: Libre 3+

Interventions

Libre 3+DEVICE

Blinded CGM will be worn by all participants

Also known as: blinded CGM
Participants post liver transplant

Eligibility Criteria

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

inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL

You may qualify if:

  • inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL

You may not qualify if:

  • having a planned discharge to a rehabilitation or nursing facility,
  • a contraindication to sensor placement,
  • if discharge is anticipated to be \>30 days post-transplant, or
  • if recent transplant also included a kidney or pancreas transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperglycemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Grenye O'Malley, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2025

First Posted

October 14, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

October 5, 2027

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Identifying dates

Locations