NCT07494188

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

Study Start

First participant enrolled

February 23, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 27, 2026

Last Update Submit

March 19, 2026

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesAdolescentsSleep health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Study Arms (1)

Sleep Intervention

EXPERIMENTAL

All adolescents enrolled will complete the sleep screening questionnaire

Behavioral: Sleep intervention

Interventions

Sleep interventionBEHAVIORAL

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.

Sleep Intervention

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Undiagnosed or untreated sleep disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Erin Cobry, MD

    University Of Colorado, Barbara Davis Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 27, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)