Menu
Enrolling by invitation NCT07494188

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep intervention.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Intervention Completion Rate [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Undiagnosed or untreated sleep disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Barbara Davis Center for Diabetes — Aurora

Identifiers

NCT: NCT07494188 · 25-0843

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗