CBTi for Insomnia in Type 1 Diabetes
This 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).
Sleep quality improvement therapy
+ Healthy Living
Autoimmune Diseases+11
+ Mental Disorders
+ Diabetes Mellitus
Treatment Study
Summary
Study start date: December 1, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 * Able to attend 3 office visits Exclusion Criteria: * 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). * Take medications for sleep * moderately severe to severe depression * Have a significant medical history that includes conditions like heart failure, cirrhosis, COPD, diseases requiring oxygen, active treatment for cancer or psychiatric problems, history of stroke with neurological deficits, cognitive impairment, kidney failure that requires dialysis, illicit drug use, use of ADHD stimulant medications.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
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