Liver Transplant CGM | NCT07216508

Studies
Liver Transplant CGM

NCT07216508

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Recruiting

Last Update Posted

Nov 12, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Liver Transplant
Post Transplant Diabetes
Type 2 Diabetes

Interventions

Libre 3+

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2025Actual

Primary Completion Date

Oct 5, 2026Estimated

Completion Date

Oct 5, 2027Estimated

First Submitted Date

Oct 9, 2025

First Submission Date that Met QC Criteria

Oct 9, 2025

First Posted Date

Oct 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2025

Last Update Posted Date

Nov 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grenye O'Malley, Associate Professor, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants post liver transplant		Participants who are discharged from after liver transplant.	Device: Libre 3+

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Libre 3+	Device	Blinded CGM will be worn by all participants	Participants post liver transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time in range	Time in range 70-180mg/dL	28 days

Secondary Outcomes

Measure	Description	Time Frame
Percent time >180mg/dL	Percent time >180mg/dL	28 days
Percent time >250mg/dL	Percent time >250mg/dL	28 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grenye O'Malley	Contact	212-241-7173		grenye.o'malley@mssm.edu
Alexa Brett	Contact	212-241-7586		alexa.brett@mssm.edu

Overall Officials

Name	Affiliation	Role
Grenye O'Malley, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital	Recruiting	New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Identifying dates

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D006943	Hyperglycemia
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided