CGM After Discharge From Hospital

NCT07510386 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY-25-01370
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Steroid-induced Diabetes

Keywords

discharge; CGM

Outcome Measures

Primary Outcomes (1)

• time in range 70-180 mg/dl

  percent time in range for last 10 days of study

  Day 20-30

Secondary Outcomes (5)

• 30 day time in range

  Day 30

• Percent time >180mg/dL

  Day 30

• Percent time >250mg/dL

  Day 30

• Percent time <70mg/dL

  Day 30

• Percent time <54mg/dL

  Day 30

Study Arms (2)

Libre 3 Plus continuous glucose monitoring (CGM) system

EXPERIMENTAL

use of unmasked continuous glucose monitoring

Device: Libre 3 Plus continuous glucose monitoring (CGM) system

Blinded CGM and fingerstick monitoring

ACTIVE COMPARATOR

Self-monitoring blood glucose (SMBG)+masked CGM

Device: Blinded Continuous Glucose Monitoring; Behavioral: Finger stick

Interventions

Libre 3 Plus continuous glucose monitoring (CGM) system DEVICE

Use of unmasked CGM after discharge

Libre 3 Plus continuous glucose monitoring (CGM) system

Blinded Continuous Glucose Monitoring DEVICE

Masked CGM

Blinded CGM and fingerstick monitoring

Finger stick BEHAVIORAL

Self-monitoring blood glucose

Blinded CGM and fingerstick monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Grenye O'Malley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Baum

CONTACT

212-241-7173; sophie.baum@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized control trial

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)