Type 1 DiabetesNCT05370339
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes
An observational study of Type 1 Diabetes and Insufficient Sleep, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Insufficient Sleep
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Aug 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescents with type 1 diabetes
Who may be able to join
- Diagnosed with T1D at least 3 months
- Receive clinical care at the Barbara Davis Center
Who cannot join
- Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
- Participation in an interventional research protocol
- Unable to complete study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Barbara Davis Center
Aurora, Colorado, 80045
About this study
The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.
- Conditions
- Type 1 Diabetes, Insufficient Sleep
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Deprivation
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 |
|---|---|---|
| Adolescents | Adolescents with type 1 diabetes between the ages of 11 and 17 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nocturnal awakenings per week
We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep.
Measured: One week per participant
Assessment of facilitators and barriers to good sleep quality and duration
Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health.
Measured: One week per participant
Secondary outcomes (1)
Identification of common causes of sleep disruptors in adolescents with type 1 diabetes
Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes.
Measured: One week per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Jun 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370339
- Sponsor's protocol ID
- 21-4311
- Status last verified
- Sep 2023
- First submitted
- 6 May 2022
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05370339
- Acronym / sponsor ID
- 21-4311
- Conditions
- Type 1 Diabetes, Insufficient Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 11 May 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.
The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –Adolescents with type 1 diabetes between the ages of 11 and 17 years. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents with type 1 diabetes
Key inclusion criteria (2 listed)
- Diagnosed with T1D at least 3 months
- Receive clinical care at the Barbara Davis Center
Key exclusion criteria (3 listed)
- Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
- Participation in an interventional research protocol
- Unable to complete study procedures
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
Number of nocturnal awakenings per week
Time frame: One week per participant
We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep.
Assessment of facilitators and barriers to good sleep quality and duration
Time frame: One week per participant
Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health.
1 secondary outcome
Identification of common causes of sleep disruptors in adolescents with type 1 diabetes
Time frame: One week per participant
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 1 Diabetes and Insufficient Sleep, run by University of Colorado, Denver 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 2 inclusion and 3 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 21 Sep 2023. 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?
Number of nocturnal awakenings per week (time frame: One week per participant). The study lists 2 primary outcomes in all. 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 21 Sep 2023.