Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes

Recruiting

• Conditions: Cystic Fibrosis Related Diabetes; Hyperglycaemia; Insomnia; Cardiometabolic Diseases; Circadian Rhythm Disorders

• Registration Number: NCT06700889
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this at-home, remote study is to understand how tube feeding affects 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 receiving HEN (targeting 15 receiving overnight and 15 daytime HEN) 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 receiving HEN and to generate preliminary data to power a future clinical trial.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-18
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-04-02
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adult men or non-pregnant women volunteers (age 18-79) Able and willing to give consent and comply with procedures Currently on routine home enteral nutrition (at least 3 months) 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Intradaily Stability	10 days	A measure of consistency in daily activity patterns, derived from 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.
Time Below Range (<54 mg/dL)	10 days	Percentage of time glucose levels fall below 54 mg/dL, derived from CGM.
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.
Number of Awakenings	10 days	Total number of awakenings during the sleep period, measured by actigraphy.
Wake After Sleep Onset (WASO)	10 days	Total time in minutes spent awake after initially falling asleep, measured by actigraphy.
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States