Recruiting

Continuous Glucose Monitoring

Sponsor:

NYU Langone Health

Code:

NCT05548205

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor

Blood Glucose Monitor

Study Details

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 ID

NCT05548205

Start date

Dec 16, 2024

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Continuous Glucose Monitoring (CGM)

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

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.

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.

Blood Glucose Monitor

Self-administered according to investigator instruction.

Primary outcome measure

  • Percentage Change in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Month 3 Post-Discharge ]

Central Contacts and Locations

Central contacts

Michael Goldstein

516-663-3511Michael.Goldstein@nyulangone.org

Locations

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Michael Goldstein

516-663-3511Michael.Goldstein@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Continuous Glucose Monitoring (CGM)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-07.