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

NCT ID: NCT05548205

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2027-04-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitoring (CGM)

Patients in the CGM group will be instructed to wear a CGM uninterruptedly for 2 weeks duration.

Group Type: EXPERIMENTAL

Continuous Glucose Monitor

Intervention Type: DEVICE

Manufactured by Abbott Diabetes Care Inc. Administered by trained investigator prior to hospital discharge, left in place for 2 weeks duration, then removed.

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.

Group Type: ACTIVE_COMPARATOR

Blood Glucose Monitor

Intervention Type: DEVICE

Self-administered according to investigator instruction.

Interventions

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.

Intervention Type: DEVICE

Blood Glucose Monitor

Self-administered according to investigator instruction.

Intervention Type: DEVICE

Other Intervention Names

Dexcom G7

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Goldstein

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Hospital - Long Island

Locations

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Goldstein

Role: CONTACT

Michael.Goldstein@nyulangone.org

516-663-3511

Facility Contacts

Michael Goldstein

Role: primary

Michael.Goldstein@nyulangone.org

516-663-3511

Other Identifiers

22-01051

Identifier Type: -

Identifier Source: org_study_id