CBTi for the Treatment of Insomnia in Type 1 Diabetes

University of Illinois

Status and phase: Enrolling; Early Phase 1

Conditions: Insomnia; Diabetes Mellitus Type 1

Treatments: Behavioral: Healthy Living; Behavioral: Sleep quality improvement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07091318

2024-0987

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Cognitive Behavioral Therapy Intervention for Insomnia

Experimental group

Description:

Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes.

Treatment:

Behavioral: Sleep quality improvement therapy

Healthy Living

Active Comparator group

Description:

Psychoeducation about general health and sleep alongside brief calls from a coach will be provided.

Treatment:

Behavioral: Healthy Living