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

Part of paid clinical trials in Mineola, New York.

Sponsor
NYU Langone Health
Study ID
NCT05548205
Status
Recruiting
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Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Blood Glucose Monitor — DEVICE
    Self-administered according to investigator instruction.

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone Hospital - Long IslandMineolaNew York11501
Michael Goldstein
[email protected]
516-663-3511

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By research site
NYU Langone Hospital - Long Island· Mineola, NY

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