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| Name | Class |
|---|---|
| Trustees of Dartmouth College | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
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The goal of this at-home, remote study is to understand the relationship between blood sugars and sleep in adults living with Cystic Fibrosis Related Diabetes (CFRD).
The study is a 10-day home-based, observational study of 30 adults with CFRD aimed at concurrently phenotyping glucose, sleep, and circadian rhythms. The remote study is designed to reduce participant burden while allowing for safe and robust objective data and specimen collection and to inform future clinical trial design. The objective of the proposed pilot and feasibility clinical study is to assess the feasibility of remotely phenotyping glycemia, sleep, and circadian rhythms of adults living with CFRD and to generate preliminary data to power a future clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEN group | This group will include participants who habitually use home enteral nutrition (HEN). | ||
| No HEN Group | This group will include participants who do not use home enteral nutrition (HEN). |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | Primary feasibility measure, defined by the completion of all study procedures and the return of study devices after the 10-day study period. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Feasibility measure, assessing the number of participants who successfully enroll. | Through study completion, an average of 1 year |
| Percentage of time glucose levels | Percentage of time glucose levels are within 70-180 mg/dL, derived from CGM. |
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Inclusion Criteria:
Adult men or non-pregnant women volunteers (age 18-79) Able and willing to give consent and comply with procedures Known diagnosis of CF Related Diabetes (CFRD) and clinically stable with no significant changes in therapies within the prior 3 months
Concomitant Medications:
A. No initiation of an investigational drug within prior 28 days B. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within prior 28 days C. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within prior 14 days D. No starting/stopping modulator therapy in the prior 3 months
Exclusion Criteria:
Blind, deaf, or unable to speak English Pregnant, nursing, or plan on pregnancy Current use of melatonin and unwilling to stop during the study With skin condition that precludes wearing sensors Within the last 4 weeks, acute CF exacerbation requiring IV antibiotics or hospitalization Major changes in diet or physical activity level in the last 4 weeks Untreated sleep and circadian disorders
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Cystic fibrosis-related diabetes patients living in the US and identified from various sources: Rally website, the MGH Adult CF Program, the CF Foundation EnVision program, and the Oley Foundation.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan S Dashti, Ph.D., R.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Rally \| Cystic Fibrosis Related Diabetes and Tube Feeding | View source |
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We do not plan to share Individual Participant Data (IPD) with other researchers as the information collected, which includes detailed glucose profiles, sleep patterns, and circadian rhythm data from individuals with CFRD, is classified as protected health information.
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D021081 | Chronobiology Disorders |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 10 days |
| Number of CGM Days | Total number of days with usable CGM data collected across participants. | 10 days |
| Number of Actigraphy Days | Total number of days with usable actigraphy data collected across participants. | 10 days |
| Number of Completed At-Home Kits (HbA1c) | Total number of at-home HbA1c kits successfully completed and returned. | 10 days |
| Total number of days with usable food records collected across participants. | Total number of days with usable food records collected across participants. | 10 days |
| Percentage of Time Above Range (>180 mg/dL) | Percentage of time glucose levels are above 180 mg/dL, derived from CGM. | 10 days |
| Time Below Range (<54 mg/dL) | Percentage of time glucose levels fall below 54 mg/dL, derived from CGM. | 10 days |
| Mean Glucose | Average glucose level across the study period, derived from CGM. | 10 days |
| Glucose Variability | Variability in glucose levels, including standard deviation and coefficient of variability, derived from CGM. | 10 days |
| Number of Awakenings | Total number of awakenings during the sleep period, measured by actigraphy. | 10 days |
| Wake After Sleep Onset (WASO) | Total time in minutes spent awake after initially falling asleep, measured by actigraphy. | 10 days |
| Sleep Efficiency | Ratio of sleep duration to time in bed, expressed as a percentage, measured by actigraphy. | 10 days |
| Sleep Latency | Time taken to fall asleep after going to bed, measured by actigraphy. | 10 days |
| Intradaily Stability | A measure of consistency in daily activity patterns, derived from actigraphy. | 10 days |
| Interdaily Variability | A measure of day-to-day variability in activity patterns, derived from actigraphy. | 10 days |
| Daily Energy Intake | Total daily caloric intake derived from food records. | 4 days |
| Healthy Eating Index | Indicator of dietary quality derived from food records. | 4 days |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D004700 | Endocrine System Diseases |