Liver TransplantNCT07216508
Liver Transplant CGM
An observational study of Liver Transplant and Post Transplant Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant, Post Transplant Diabetes, Type 2 Diabetes
- What is being tested?
- Libre 3+
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL
Who may be able to join
- inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post-discharge Glycemic Control After Liver Transplant and Impact on Transplant Outcomes
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.
Read the 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.
- Conditions
- Liver Transplant, Post Transplant Diabetes, Type 2 Diabetes
- Being tested
- Libre 3+
- Keywords
- liver transplant, hyperglycemia, diabetes, continuous glucose monitoring, glucose sensor
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libre 3+Device
Also called blinded CGM
Blinded CGM will be worn by all participants
| Study group | Role | What they receive |
|---|---|---|
| Participants post liver transplant | Participants who are discharged from after liver transplant. Receives: Device: Libre 3+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Time in range 70-180mg/dL
Measured: 28 days
Secondary outcomes (5)
Percent time >180mg/dL
Percent time >180mg/dL
Measured: 28 days
Percent time >250mg/dL
Percent time >250mg/dL
Measured: 28 days
Percent time <70mg/dL
Percent time <70mg/dL
Measured: 28 days
Percent time <54mg/dL
Percent time <54mg/dL
Measured: 28 days
Transplant outcomes
Rate and time to of wound complications, vascular complications, biliary complications, acute kidney injury, transplant rejection, and readmissions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start13 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grenye O'Malley, Icahn School of Medicine at Mount Sinai
- Investigators
- Grenye O'Malley, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216508
- Sponsor's protocol ID
- STUDY-24-01098
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Identifying dates
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-discharge Glycemic Control After Liver Transplant and Impact on Transplant Outcomes
- ClinicalTrials.gov ID
- NCT07216508
- Acronym / sponsor ID
- STUDY-24-01098
- Conditions
- Liver Transplant, Post Transplant Diabetes, Type 2 Diabetes
- Keywords
- liver transplant, hyperglycemia, diabetes, continuous glucose monitoring, glucose sensor
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants post liver transplant | – | Device: Libre 3+Participants who are discharged from after liver transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL
Key inclusion criteria (1 listed)
- inpatient liver transplant participants who have had an inpatient glucose greater than 180mg/dL
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Libre 3+Also: blinded CGMBlinded CGM will be worn by all participants | Device | Participants post liver transplant |
Primary outcome
Time in range
Time frame: 28 days
Time in range 70-180mg/dL
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. Identifying dates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grenye O'Malley, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant and Post Transplant Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.