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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK092949 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Chicago | OTHER |
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Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glucose control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration less than 6-6.5 hours per night. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glucose control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of strategies to improve sleep on diabetes distress, and glucose control is limited. The purpose of this pilot study is to evaluate the effects of a sleep intervention on sleep duration, diabetes distress and glucose control in individuals with T1D and habitual short sleep. A randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Eligible participants will be randomly assigned to a sleep intervention group or a control group. Differences between the two groups on the outcomes of sleep duration, diabetes distress and glucose control will be evaluated. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glucose control.
Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glycemic control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration < 6-6.5 hours per night, either by self-report or objectively assessed actigraphy. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glycemic control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of sleep optimization on sleep, diabetes distress, and glycemic control is limited. The purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of sleep, diabetes distress and glycemic control in individuals with T1D and habitual short sleep. The specific aims are to determine if Sleep-Opt-In will: 1) be feasible and acceptable to the target population; 2) result in improved sleep duration and regularity; 3) result in improved glycemic control; and 4) lower diabetes distress. To achieve these aims, a randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Participants will be screened for habitual sleep duration < 6.5 hours per night. Eligible subjects will be randomized to the T1D-Sleep-Opt-In group or attention control group. A one-week run-in period is planned, with baseline measures of sleep (duration and regularity), glycemia (A1C, fructosamine, glycemic variability), and diabetes distress (Diabetes Distress Scale). The T1D-Sleep-Opt-In will entail a novel technology-assisted behavioral sleep extension intervention developed to leverage rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). This technology employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The intervention will be T1D-specific by addressing T1D-related sleep issues such as nocturnal hypoglycemia. The attention control group will participate in a healthy living information program. At completion (Week 8) and post-program (Weeks 12 and 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep-Opt-In | Experimental | Sleep optimization intervention |
|
| Healthy Living | Active Comparator | Health education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Opt-In | Behavioral | 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration | change in minutes of sleep (actigraphy-derived) | Assessing change between two time points:Week 0 to week 8 |
| Sleep Regularity | Change in sleep regularity (variability) | Assessing change between two time points: from week 0 to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c (A1C%) | Change between two time points, week 0 to week 8 |
| Glucose Variability | Change in glucose variability (CV%) (continuous glucose monitor derived) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Martyn-Nemeth, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep-Opt-In | Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling |
| FG001 | Healthy Living | Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep-Opt-In | Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling |
| BG001 | Healthy Living |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Duration | change in minutes of sleep (actigraphy-derived) | Posted | Mean | Standard Deviation | minutes | Assessing change between two time points:Week 0 to week 8 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep-Opt-In | Sleep optimization intervention Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Martyn-Nemeth | University of Illinois at Chicago | 3129967903 | pmartyn@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2019 | Jul 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Sleep optimization intervention will be compared to a healthy living attention control
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| Healthy Living | Behavioral | 8-week intervention that includes weekly telephone counseling on healthy living. |
|
| Assessing change between two time points: from week 0 to week 8 |
| Diabetes Distress | Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation: < 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress | Assessing change between two time points: from week 0 to week 8 |
Health education
Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | Sleep Regularity | Change in sleep regularity (variability) | Posted | Mean | Standard Deviation | minutes | Assessing change between two time points: from week 0 to week 8 |
|
|
|
| Secondary | HbA1c | HbA1c (A1C%) | Posted | Mean | Standard Deviation | % of glucose saturation on hemoglobin | Change between two time points, week 0 to week 8 |
|
|
|
| Secondary | Glucose Variability | Change in glucose variability (CV%) (continuous glucose monitor derived) | Posted | Mean | Standard Deviation | percentage of CV | Assessing change between two time points: from week 0 to week 8 |
|
|
|
| Secondary | Diabetes Distress | Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation: < 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress | Posted | Mean | Standard Deviation | change in score on a scale | Assessing change between two time points: from week 0 to week 8 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Healthy Living | Health education Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001523 | Mental Disorders |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |