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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:
Participants in the healthy living group will:
Participants, regardless of intervention, over the 12 week study period will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy Intervention for Insomnia | Experimental | Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes. |
|
| Healthy Living | Active Comparator | Psychoeducation about general health and sleep alongside brief calls from a coach will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep quality improvement therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | From enrollment to the end of the intervention (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | Assessed as time in, above or below range as collected by the continuous glucose monitor. | Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment) |
| Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Duffecy, PhD | Contact | 312-413-1225 | jduffecy@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
Access to individual data will be restricted to the principle investigator and authorized members of the research team-- who will be trained on data confidentiality and how to handle secure data.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be randomly assigned to either the treatment group or the control group.
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| Healthy Living | Behavioral | 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. |
|
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.
| Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment) |
| Glycemic Control | Assessed through A1C | Week 0 (baseline) and Week 12 (end of treatment) |
| Sleep duration | Measured by actigraphy watch | Week 0 (baseline) and Week 12 (end of treatment) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance | 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. | Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |