Type 2 DiabetesNCT07510386
CGM After Discharge From Hospital
A study testing Libre 3 Plus continuous glucose monitoring (CGM) system, Blinded Continuous Glucose Monitoring and Finger stick in people with Type 2 Diabetes and Steroid-induced Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Steroid-induced Diabetes
- What is being tested?
- Libre 3 Plus continuous glucose monitoring (CGM) system, Blinded Continuous Glucose Monitoring and Finger stick
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to Nov 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adult 18 years or older.
- Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.
Who cannot join
- Type 1 diabetes
- Plan for discharge to rehabilitation/skilled nursing/hospice facility
- Contra-indication to sensor placement
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10035
Grenye O'Malley, MD, 212-241-7173, grenye.o'malley@mssm.edu
Sophie Baum, sophie.baum@mssm.edu
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes, Steroid-induced Diabetes
- Being tested
- Libre 3 Plus continuous glucose monitoring (CGM) system, Blinded Continuous Glucose Monitoring, Finger stick
- Keywords
- discharge, CGM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libre 3 Plus continuous glucose monitoring (CGM) systemDevice
Use of unmasked CGM after discharge
Blinded Continuous Glucose MonitoringDevice
Masked CGM
Finger stickBehavioural
Self-monitoring blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Libre 3 Plus continuous glucose monitoring (CGM) system | Experimental | use of unmasked continuous glucose monitoring Receives: Device: Libre 3 Plus continuous glucose monitoring (CGM) system |
| Blinded CGM and fingerstick monitoring | Active comparator | Self-monitoring blood glucose (SMBG)+masked CGM Receives: Device: Blinded Continuous Glucose Monitoring; Behavioral: Finger stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in range 70-180 mg/dl
percent time in range for last 10 days of study
Measured: Day 20-30
Secondary outcomes (5)
30 day time in range
Overall 30 day time in range
Measured: Day 30
Percent time >180mg/dL
percent time in range on day 30
Measured: Day 30
Percent time >250mg/dL
percent time in range on day 30
Measured: Day 30
Percent time <70mg/dL
percent time in range on day 30
Measured: Day 30
Percent time <54mg/dL
percent time in range on day 30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Sep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT07510386
- Sponsor's protocol ID
- STUDY-25-01370
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Dates tied to admission which is identifying
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring for Post-discharge Diabetes Management
- ClinicalTrials.gov ID
- NCT07510386
- Acronym / sponsor ID
- STUDY-25-01370
- Conditions
- Type 2 Diabetes, Steroid-induced Diabetes
- Keywords
- discharge, CGM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Apr 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Libre 3 Plus continuous glucose monitoring (CGM) system | Experimental | Device: Libre 3 Plus continuous glucose monitoring (CGM) systemuse of unmasked continuous glucose monitoring |
| Blinded CGM and fingerstick monitoring | Active comparator | Device: Blinded Continuous Glucose Monitoring, Behavioral: Finger stickSelf-monitoring blood glucose (SMBG)+masked CGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult 18 years or older.
- Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Plan for discharge to rehabilitation/skilled nursing/hospice facility
- Contra-indication to sensor placement
- Pregnancy
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 Plus continuous glucose monitoring (CGM) systemUse of unmasked CGM after discharge | Device | Libre 3 Plus continuous glucose monitoring (CGM) system |
| Blinded Continuous Glucose MonitoringMasked CGM | Device | Blinded CGM and fingerstick monitoring |
| Finger stickSelf-monitoring blood glucose | Behavioural | Blinded CGM and fingerstick monitoring |
Primary outcome
time in range 70-180 mg/dl
Time frame: Day 20-30
percent time in range for last 10 days of study
5 secondary outcomes
30 day time in range
Time frame: Day 30
Percent time >180mg/dL
Time frame: Day 30
Percent time >250mg/dL
Time frame: Day 30
Percent time <70mg/dL
Time frame: Day 30
Percent time <54mg/dL
Time frame: Day 30
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 10 Aug 2026.
- Individual participant dataSharing planned: No. Dates tied to admission which is identifying
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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?
A study testing Libre 3 Plus continuous glucose monitoring (CGM) system, Blinded Continuous Glucose Monitoring and Finger stick in people with Type 2 Diabetes and Steroid-induced 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 2 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: opening soon, as of the sponsor's last update on 10 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?
Contact Sophie Baum (212-241-7173, sophie.baum@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time in range 70-180 mg/dl (time frame: Day 20-30). 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 10 Aug 2026.