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Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities

Sponsor
Joslin Diabetes Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05711108
Collaborator
Theoria Medical (Other)
300
Enrollment
10.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications).

This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities
    Anticipated Study Start Date :
    Feb 28, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Long Term Care Residents Using Glucose Lowering Medication

    Outcome Measures

    Primary Outcome Measures

    1. Biochemical hypoglycemia [Baseline]

      minutes per day sensor glucose <70 mg/dL

    Secondary Outcome Measures

    1. A1C [Baseline]

    2. Time-in-range [Baseline]

      percent/day over 10 days of glucose value between 90-180 mg/dl or 90-250 mg/dl depending current ADA recommendations)

    3. Clinically significant hypoglycemia [Baseline]

      minutes per day sensor glucose <54 mg/dl

    4. Severe hypoglycemia [Baseline]

      needing 3rd party assistance

    5. Falls, hospitalization [Baseline]

    6. Symptoms of hypoglycemia reported to the staff by the resident in between or at the time of fingerstick glucose monitoring (information derived from nursing notes) [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults >64 years with diagnosis of type 1 or type 2 diabetes

    • Using glucose-lowering medication or insulin

    Exclusion Criteria:

    • Currently taking or planning to take hydroxyurea

    • Patient or Health care proxy refuses to sign consent form

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Joslin Diabetes Center
    • Theoria Medical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joslin Diabetes Center
    ClinicalTrials.gov Identifier:
    NCT05711108
    Other Study ID Numbers:
    • STUDY00000128
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Joslin Diabetes Center
    older adults
    hypoglycemia
    continuous glucose monitoring
    long-term care facilities
    Additional relevant MeSH terms:
    Hypoglycemia

    Study Results

    No Results Posted as of Feb 2, 2023