Sleep Screening and Intervention for Adolescents With Type 1 Diabetes in a Clinical Diabetes Center

March 19, 2026 updated by: University of Colorado, Denver
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Barbara Davis Center for Diabetes

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 1 diabetes
  • Receiving care at the Barbara Davis Center
  • Using a continuous glucose monitor

Exclusion Criteria:

  • Undiagnosed or untreated sleep disorder

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Intervention
All adolescents enrolled will complete the sleep screening questionnaire
Behavioral: Sleep intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Erin Cobry, MD, University Of Colorado, Barbara Davis Center

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 (Actual)

February 23, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-0843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing can be made available upon request on a case by case basis

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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