Cardiometabolic Diseases, Circadian Rhythm Disorders, Cystic Fibrosis Related Diabetes, Hyperglycaemia, Insomnia
Conditions
Keywords
Cystic Fibrosis Related Diabetes, Tube Feeds, Circadian Rhythm, Diabetes, Home Enteral Nutrition, Circadian misalignment, Nutrition
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
Trustees of Dartmouth College
Harvard Medical School (HMS and HSDM)
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 10 days | Primary feasibility measure, defined by the completion of all study procedures and the return of study devices after the 10-day study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wake After Sleep Onset (WASO) | 10 days | Total time in minutes spent awake after initially falling asleep, measured by actigraphy. |
| Enrollment Rate | Through study completion, an average of 1 year | Feasibility measure, assessing the number of participants who successfully enroll. |
| Percentage of time glucose levels | 10 days | Percentage of time glucose levels are within 70-180 mg/dL, derived from CGM. |
| Number of CGM Days | 10 days | Total number of days with usable CGM data collected across participants. |
| Number of Actigraphy Days | 10 days | Total number of days with usable actigraphy data collected across participants. |
| Number of Completed At-Home Kits (HbA1c) | 10 days | Total number of at-home HbA1c kits successfully completed and returned. |
| Total number of days with usable food records collected across participants. | 10 days | Total number of days with usable food records collected across participants. |
| Percentage of Time Above Range (>180 mg/dL) | 10 days | Percentage of time glucose levels are above 180 mg/dL, derived from CGM. |
| Number of Awakenings | 10 days | Total number of awakenings during the sleep period, measured by actigraphy. |
| Mean Glucose | 10 days | Average glucose level across the study period, derived from CGM. |
| Glucose Variability | 10 days | Variability in glucose levels, including standard deviation and coefficient of variability, derived from CGM. |
| Sleep Efficiency | 10 days | Ratio of sleep duration to time in bed, expressed as a percentage, measured by actigraphy. |
| Sleep Latency | 10 days | Time taken to fall asleep after going to bed, measured by actigraphy. |
| Intradaily Stability | 10 days | A measure of consistency in daily activity patterns, derived from actigraphy. |
| Interdaily Variability | 10 days | A measure of day-to-day variability in activity patterns, derived from actigraphy. |
| Daily Energy Intake | 4 days | Total daily caloric intake derived from food records. |
| Healthy Eating Index | 4 days | Indicator of dietary quality derived from food records. |
| Time Below Range (<54 mg/dL) | 10 days | Percentage of time glucose levels fall below 54 mg/dL, derived from CGM. |
Countries
United States
Outcome results
None listed