MedTrace Logo

CBTi for the Treatment of Insomnia in Type 1 Diabetes

NCT07091318 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-22

No results posted yet for this study

Summary

The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:

Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?

Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.

Participants in the therapy intervention group will:

* meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.

Participants in the healthy living group will:

* receive weekly health education emails
* receive brief weekly calls from a coach to answer any questions

Participants, regardless of intervention, over the 12 week study period will:

* monitor their sleep for 2 weeks through a sleep-monitoring watch
* share their continuous glucose monitoring data throughout the study
* answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
* attend 3 in person office visits

Conditions

Interventions

BEHAVIORAL

Sleep quality improvement therapy

8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study.

BEHAVIORAL

Healthy Living

Health education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091318 on ClinicalTrials.gov