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.
Study Type
OBSERVATIONAL
Enrollment
30
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 10 days
Enrollment Rate
Feasibility measure, assessing the number of participants who successfully enroll.
Time frame: 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.
Time frame: 10 days
Number of CGM Days
Total number of days with usable CGM data collected across participants.
Time frame: 10 days
Number of Actigraphy Days
Total number of days with usable actigraphy data collected across participants.
Time frame: 10 days
Number of Completed At-Home Kits (HbA1c)
Total number of at-home HbA1c kits successfully completed and returned.
Time frame: 10 days
Total number of days with usable food records collected across participants.
Total number of days with usable food records collected across participants.
Time frame: 10 days
Percentage of Time Above Range (>180 mg/dL)
Percentage of time glucose levels are above 180 mg/dL, derived from CGM.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 10 days
Time Below Range (<54 mg/dL)
Percentage of time glucose levels fall below 54 mg/dL, derived from CGM.
Time frame: 10 days
Mean Glucose
Average glucose level across the study period, derived from CGM.
Time frame: 10 days
Glucose Variability
Variability in glucose levels, including standard deviation and coefficient of variability, derived from CGM.
Time frame: 10 days
Number of Awakenings
Total number of awakenings during the sleep period, measured by actigraphy.
Time frame: 10 days
Wake After Sleep Onset (WASO)
Total time in minutes spent awake after initially falling asleep, measured by actigraphy.
Time frame: 10 days
Sleep Efficiency
Ratio of sleep duration to time in bed, expressed as a percentage, measured by actigraphy.
Time frame: 10 days
Sleep Latency
Time taken to fall asleep after going to bed, measured by actigraphy.
Time frame: 10 days
Intradaily Stability
A measure of consistency in daily activity patterns, derived from actigraphy.
Time frame: 10 days
Interdaily Variability
A measure of day-to-day variability in activity patterns, derived from actigraphy.
Time frame: 10 days
Daily Energy Intake
Total daily caloric intake derived from food records.
Time frame: 4 days
Healthy Eating Index
Indicator of dietary quality derived from food records.
Time frame: 4 days