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

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05548205
Collaborator
Abbott Diabetes Care Inc (Other)
120
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
13.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous Glucose Monitor
  • Device: Blood Glucose Monitor
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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:
  • Freestyle Libre 2

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage Change in Hemoglobin A1c (HbA1c) [Baseline, Month 3 Post-Discharge]

      Assessed via CGM or BGM.

    Secondary Outcome Measures

    1. Number of Hospital Admissions [Up to Month 3 Post-Discharge]

    2. Number of Emergency Department (ER) Visits [Up to Month 3 Post-Discharge]

    3. Number of Hypoglycemic Events [Up to Month 3 Post-Discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 September 1st, 2022 and August 31st, 2023

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Hospital - Long Island Mineola New York United States 11501

    Sponsors and Collaborators

    • NYU Langone Health
    • Abbott Diabetes Care Inc

    Investigators

    • Principal Investigator: Stanislaw Klek, NYU Langone Hospital - Long Island

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT05548205
    Other Study ID Numbers:
    • 22-01051
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by NYU Langone Health
    Continuous Glucose Monitoring (CGM)

    Study Results

    No Results Posted as of Sep 21, 2022