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CBTi for Insomnia in Type 1 Diabetes

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Study AimThis early phase study evaluates the acceptance of Cognitive Behavioral Therapy for Insomnia (CBTi) in Type 1 Diabetes patients, measured through the Acceptability of Intervention Measure (AIM).
What is being tested

Sleep quality improvement therapy

+ Healthy Living
Behavioral
Who is being recruted

Diabetes Mellitus Type 1

+ Insomnia
From 18 to 65 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of Illinois at Chicago
Study ContactJennifer Duffecy, PhD
Last updated: September 19, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study focuses on people with type 1 diabetes who also have trouble sleeping, known as insomnia. The main aim is to find out if a specific therapy for insomnia can help improve sleep, control blood sugar levels, and enhance the overall quality of life, including mood and energy levels. Understanding this could lead to better management of diabetes by addressing sleep issues, potentially improving health and daily living for those affected. Participants in the study will experience different types of support. Some will have virtual sessions with a therapist to work on their sleep problems, while others will receive health tips and guidance through emails and phone calls. All participants will wear a special watch to track their sleep, share their blood sugar data, answer surveys, and attend office visits throughout the 12-week study. This structured approach helps researchers determine the effectiveness of the insomnia therapy by comparing it to general health advice.

Official TitleCBTi for the Treatment of Insomnia in Type 1 Diabetes 
Principal SponsorUniversity of Illinois at Chicago
Study ContactJennifer Duffecy, PhD
Last updated: September 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus Type 1
Insomnia
Criteria
5 inclusion criteria required to participate
Between 18 to 65 years old
Have been diagnosed with Type 1 Diabetes for at least a year
Use a continuous glucose monitor
Have poor sleep quality

Show More Criteria

7 exclusion criteria prevent from participating
Currently or planning pregnancy or breast feeding
Employed with a rotating or night shift
Are at a high risk for obstructive sleep apnea
Non-English speaking (unable to participate in therapy or questionnaire).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes.
Group II
Active Comparator
Psychoeducation about general health and sleep alongside brief calls from a coach will be provided.
Study Objectives
Primary Objectives

Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
Secondary Objectives

Assessed as time in, above or below range as collected by the continuous glucose monitor.

The PSQI is a questionnaire that assesses sleep quality and disturbances within the last month. It consists of 18 questions that either have scaled questions with four options or asks the participant for input regarding factors like bed time, time to fall asleep, hours of sleep etc. Each participant answer, both on the scale and on input, is assigned a score between 0 and 3. Thus, the score range goes from 0 to 54, with a higher score indicating worse sleep quality.

Assessed through A1C

Measured by actigraphy watch

The PROMIS questionnaire assesses self-reported sleep quality through the lens of depth and restoration. It contains 8 questions regarding the last 7 days and is scored on a scale of 1 to 5 for each question. The scores range from 8 to 40. A higher score indicates worse sleep quality.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Illinois ChicagoChicago, United StatesSee the location
Recruiting soonOne Study Center