Circadian Rhythm; InversionNCT05559762
Impact of Night Shift Work on 24-hour Blood Glucose Levels
An observational study of Circadian Rhythm; Inversion and Metabolic Disease, run by Lincoln Memorial University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Circadian Rhythm; Inversion, Metabolic Disease
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Full time nurses working either day shifts or night shifts
Who may be able to join
- • 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Sacred Heart Hospital
Spokane, Washington, 99204
About this study
Official title: 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).
- Conditions
- Circadian Rhythm; Inversion, Metabolic Disease
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Day Shift | Nurses regularly working 12hr day shifts | |
| Night Shift | Nurses regularly working night shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr glucose
continuous glucose monitoring
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start8 Nov 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm; InversionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln Memorial University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence St Joseph Health
- Responsible party
- Principal investigator, Lindsey Miller, Lincoln Memorial University
- Investigators
- Lindsey Miller, Principal investigator, Lincoln Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559762
- Sponsor's protocol ID
- STUDY2022000529
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regular Night Shift Work on 24-hour Blood Glucose Levels in Nurses
- ClinicalTrials.gov ID
- NCT05559762
- Acronym / sponsor ID
- STUDY2022000529
- Conditions
- Circadian Rhythm; Inversion, Metabolic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lincoln Memorial UniversityUniversity, hospital or other
- Collaborators
- Providence St Joseph Health
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Shift | – | –Nurses regularly working 12hr day shifts |
| Night Shift | – | –Nurses regularly working night shift |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Full time nurses working either day shifts or night shifts
Key inclusion criteria (8 listed)
- • 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
24hr glucose
Time frame: 7 days
continuous glucose monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Miller principal investigator
Lincoln Memorial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm; Inversion and Metabolic Disease, run by Lincoln Memorial University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24hr glucose (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.