CGM After Discharge From Hospital

March 30, 2026 updated by: Grenye O'Malley, Icahn School of Medicine at Mount Sinai

Continuous Glucose Monitoring for Post-discharge Diabetes Management

This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult 18 years or older.
  • Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.

Exclusion Criteria:

  • Type 1 diabetes
  • Plan for discharge to rehabilitation/skilled nursing/hospice facility
  • Contra-indication to sensor placement
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Libre 3 Plus continuous glucose monitoring (CGM) system
use of unmasked continuous glucose monitoring
Device: Libre 3 Plus continuous glucose monitoring (CGM) system
Use of unmasked CGM after discharge
Active Comparator: Blinded CGM and fingerstick monitoring
Self-monitoring blood glucose (SMBG)+masked CGM
Device: Blinded Continuous Glucose Monitoring
Masked CGM
Behavioral: Finger stick
Self-monitoring blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time in range 70-180 mg/dl
Time Frame: Day 20-30
percent time in range for last 10 days of study
Day 20-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day time in range
Time Frame: Day 30
Overall 30 day time in range
Day 30
Percent time >180mg/dL
Time Frame: Day 30
percent time in range on day 30
Day 30
Percent time >250mg/dL
Time Frame: Day 30
percent time in range on day 30
Day 30
Percent time <70mg/dL
Time Frame: Day 30
percent time in range on day 30
Day 30
Percent time <54mg/dL
Time Frame: Day 30
percent time in range on day 30
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Grenye O'Malley, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-25-01370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Dates tied to admission which is identifying

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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