Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
Purpose
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).
Conditions
- Cystic Fibrosis Related Diabetes
- Hyperglycaemia
- Insomnia
- Cardiometabolic Diseases
- Circadian Rhythm Disorders
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Genders
- All
- Accepts 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 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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Overnight HEN group | This group will include participants who habitually feed overnight using home enteral nutrition (HEN). | |
| Daytime HEN Group | This group will include participants who habitually feed during the daytime (bolus or cycle) using home enteral nutrition (HEN). |
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.