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Recruiting NCT07216508

Liver Transplant CGM

Observational Liver Transplant Post Transplant Diabetes Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Libre 3+.
Who it may be relevant to
Registry conditions: Liver Transplant, Post Transplant Diabetes, Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Post-discharge Glycemic Control After Liver Transplant and Impact on Transplant Outcomes

Overview

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.

Detailed description

Liver transplant participants will be recruited. Participants will wear a blinded sensor after hospital discharge for up to 30 days. Data can be shared with participant and the providers retrospectively. Participants will be invited to wear another blinded sensor at 6 and 12 months.

Interventions

  • Device Libre 3+
    Blinded CGM will be worn by all participants

Primary outcome measures

  • Time in range [Time frame: 28 days]
Secondary outcome measures (5)
  • Percent time >180mg/dL [Time frame: 28 days]
  • Percent time >250mg/dL [Time frame: 28 days]
  • Percent time <70mg/dL [Time frame: 28 days]
  • Percent time <54mg/dL [Time frame: 28 days]
  • Transplant outcomes [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Mount Sinai Hospital — New York

Identifiers

NCT: NCT07216508 · STUDY-24-01098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗