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Impact of Night Shift Work on 24-hour Blood Glucose Levels

Sponsor
Lincoln Memorial University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05559762
Collaborator
Providence St Joseph Health (Other)
30
Enrollment
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will determine whether nurses regularly working night shifts have elevated 24-hour glucose levels compared to nurses regularly working day shifts, using continuous glucose monitoring (CGM).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Regular Night Shift Work on 24-hour Blood Glucose Levels in Nurses
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Day Shift

    Nurses regularly working 12hr day shifts
    Night Shift

    Nurses regularly working night shift

    Outcome Measures

    Primary Outcome Measures

    1. 24hr glucose [7 days]

      continuous glucose monitoring

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • • RNs working at least a 0.6 FTE and 12-hour night or day shift (not able to alternate between days and nights) for at least the past two months

    • Free from presence of uncontrolled chronic illness and specifically prediabetes, Type 1 or Type 2 diabetes (but not including history of gestational diabetes) and not currently taking any glucose-lowering or steroid medication

    • Not currently pregnant or breastfeeding

    • English speaking and able to provide informed consent

    • Must own and know how to operate a Smartphone

    • Must be willing and able to wear two small sensors attached by adhesive for the study duration, the Fibion SENS activity monitor and the Dexcom G6 continuous glucose monitor

    • Must regularly consume food during shifts and refrain from actively attempting weight loss during the study duration

    • Must work only one job at the time of study participation

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lincoln Memorial University
    • Providence St Joseph Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lindsey Miller, Associate Professor, Lincoln Memorial University
    ClinicalTrials.gov Identifier:
    NCT05559762
    Other Study ID Numbers:
    • STUDY2022000529
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Sep 29, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metabolic Diseases

    Study Results

    No Results Posted as of Sep 29, 2022