Type 1 DiabetesNCT07494188
Sleep Screening and Intervention for Adolescents With Type 1 Diabetes in a Clinical Diabetes Center
A study testing Sleep intervention in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is evaluating an in-clinic sleep screening and intervention algorithm for youth with type 1 diabetes. This study will assess health care provider feasibility of completion of intervention and long term follow up for adolescents with T1D. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Type 1 diabetes
- Receiving care at the Barbara Davis Center
- Using a continuous glucose monitor
Who cannot join
- Undiagnosed or untreated sleep disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
About this study
This study is evaluating an in-clinic sleep screening and intervention algorithm for youth with type 1 diabetes. This study will assess health care provider feasibility of completion of intervention and long term follow up for adolescents with T1D.
Read the detailed description
This study involves enrollment of adolescents with T1D in conjunction with a diabetes health care provider at the Barbara Davis Center. Adolescents will complete a sleep screening questionnaire prior to the clinic visit. If the adolescent screens positive for sleep concerns, they will complete an indepth questionnaire to identify the barriers to sleep and this information will be provided to the health care provider. During the routine T1D clinic visit, the health care provider will be provided with the questionnaire answers and sleep interventions, and will address these at their discretion throughout the clinical encounter. Adolescents enrolled in the study will be follow at 3 months. For those that screened positive for sleep concerns, questionnaires will be completed related to the intervention to determine completion, retention, and follow through. Those who did not screen positive, will additionally complete a follow up sleep screener to assess consistency in their sleep health.
- Conditions
- Type 1 Diabetes
- Being tested
- Sleep intervention
- Keywords
- Type 1 diabetes, Adolescents, Sleep health
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep interventionBehavioural
Adolescents that screen positive for sleep concerns will receive targeted interventions based on their self-reported sleep barriers. These will be provided by the health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention | Experimental | All adolescents enrolled will complete the sleep screening questionnaire Receives: Behavioral: Sleep intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Completion Rate
Assess the feasibility/rate of completion of sleep intervention discussion within the clinic session based on the percent of interventions completed for those who screened positive in the sleep screening.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Cobry, MD, Principal investigator, University Of Colorado, Barbara Davis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494188
- Sponsor's protocol ID
- 25-0843
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing can be made available upon request on a case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Screening and Intervention for Adolescents With Type 1 Diabetes in a Clinical Diabetes Center
- ClinicalTrials.gov ID
- NCT07494188
- Acronym / sponsor ID
- 25-0843
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Adolescents, Sleep health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (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 is evaluating an in-clinic sleep screening and intervention algorithm for youth with type 1 diabetes. This study will assess health care provider feasibility of completion of intervention and long term follow up for adolescents with T1D.
Detailed description
This study involves enrollment of adolescents with T1D in conjunction with a diabetes health care provider at the Barbara Davis Center. Adolescents will complete a sleep screening questionnaire prior to the clinic visit. If the adolescent screens positive for sleep concerns, they will complete an indepth questionnaire to identify the barriers to sleep and this information will be provided to the health care provider. During the routine T1D clinic visit, the health care provider will be provided with the questionnaire answers and sleep interventions, and will address these at their discretion throughout the clinical encounter. Adolescents enrolled in the study will be follow at 3 months. For those that screened positive for sleep concerns, questionnaires will be completed related to the intervention to determine completion, retention, and follow through. Those who did not screen positive, will additionally complete a follow up sleep screener to assess consistency in their sleep health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention | Experimental | Behavioral: Sleep interventionAll adolescents enrolled will complete the sleep screening questionnaire |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Receiving care at the Barbara Davis Center
- Using a continuous glucose monitor
Key exclusion criteria (1 listed)
- Undiagnosed or untreated sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep interventionAdolescents that screen positive for sleep concerns will receive targeted interventions based on their self-reported sleep barriers. These will be provided by the health care provider. | Behavioural | Sleep Intervention |
Primary outcome
Intervention Completion Rate
Time frame: Day 1
Assess the feasibility/rate of completion of sleep intervention discussion within the clinic session based on the percent of interventions completed for those who screened positive in the sleep screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. Data sharing can be made available upon request on a case by case basis
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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.
Erin Cobry, MD principal investigator
University Of Colorado, Barbara Davis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep intervention in people with Type 1 Diabetes, 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intervention Completion Rate (time frame: Day 1). 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 27 Mar 2026.