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

September 26, 2022 updated by: Lindsey Miller, Lincoln Memorial University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Full time nurses working either day shifts or night shifts

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Day Shift
Nurses regularly working 12hr day shifts
Night Shift
Nurses regularly working night shift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24hr glucose
Time Frame: 7 days
continuous glucose monitoring
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lincoln Memorial University

Collaborators

Providence St Joseph Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY2022000529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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