Effect of 2-Week Continuous Glucose Monitoring on Glycemi... | NCT05548205

Studies
Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge

NCT05548205

Sponsor

NYU Langone Health

Status

Recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Continuous Glucose Monitor
Blood Glucose Monitor

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

Sep 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

Dec 16, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Apr 30, 2027Estimated

First Submitted Date

Sep 16, 2022

First Submission Date that Met QC Criteria

Sep 16, 2022

First Posted Date

Sep 21, 2022Actual

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

Sep 29, 2025

Last Update Posted Date

Oct 2, 2025Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous Glucose Monitoring (CGM)	Experimental	Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.	Device: Continuous Glucose Monitor
Blood Glucose Monitoring (BGM)	Active Comparator	Patients in the BGM group will be instructed to check their blood glucose utilizing fingerstick glucose monitoring multiple times daily depending on their insulin regimen for 2 weeks duration.	Device: Blood Glucose Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Monitor	Device	Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Change in Hemoglobin A1c (HbA1c)	Assessed via CGM or BGM.	Baseline, Month 3 Post-Discharge

Secondary Outcomes

Measure	Description	Time Frame
Number of Hospital Admissions		Up to Month 3 Post-Discharge
Number of Emergency Department (ER) Visits		Up to Month 3 Post-Discharge
Number of Hypoglycemic Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18-100 years
Known history of type 1 or type 2 diabetes
Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge

Exclusion Criteria:

Prior to admission use of home insulin therapy
Current use of systemic corticosteroids
Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Goldstein	Contact	516-663-3511		Michael.Goldstein@nyulangone.org

Overall Officials

Name	Affiliation	Role
Michael Goldstein	NYU Langone Hospital - Long Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Hospital - Long Island	Recruiting	Mineola	New York	11501	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stanislaw Klek (Stanislaw.Klek@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Access Criteria

Requests should be directed to Stanislaw.Klek@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
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