CBTi for the Treatment of Insomnia in Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep quality improvement therapy, Healthy Living.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 1, Insomnia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Primary outcome measures
- Acceptability [Time frame: From enrollment to the end of the intervention (12 weeks)]
Secondary outcome measures (5)
- Glycemic Variability [Time frame: Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)]
- Glycemic Control [Time frame: Week 0 (baseline) and Week 12 (end of treatment)]
- Sleep duration [Time frame: Week 0 (baseline) and Week 12 (end of treatment)]
- Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance [Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Illinois Chicago — Chicago
Identifiers
NCT: NCT07091318 · 2024-0987