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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitor; Device: Blood Glucose Monitor

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Goldstein; Phone Number: 516-663-3511; Email: Michael.Goldstein@nyulangone.org

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Recruiting
      • NYU Langone Hospital - Long Island
      • Contact: Michael Goldstein; Phone Number: 516-663-3511; Email: Michael.Goldstein@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female aged 18-100 years
2. Known history of type 1 or type 2 diabetes
3. Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026
4. 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:

1. Prior to admission use of home insulin therapy
2. Current use of systemic corticosteroids
3. 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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring (CGM); Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.	Device: Continuous Glucose Monitor; Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.; Other Names: Dexcom G7
Active Comparator: Blood Glucose Monitoring (BGM); 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; Self-administered according to investigator instruction.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	Up to Month 3 Post-Discharge

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Abbott Diabetes Care Inc
• Investigators: Principal Investigator: Michael Goldstein, NYU Langone Hospital - Long Island

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring (CGM)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 22-01051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Requests should be directed to Stanislaw.Klek@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes