Effects of tube feeding on blood sugar and sleep in adults with cystic fibrosis-related diabetes
Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
This study is testing how tube feeding at night or during the day affects blood sugar levels and sleep in adults with cystic fibrosis-related diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06700889 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how tube feeding impacts glycemia and sleep patterns in adults diagnosed with cystic fibrosis-related diabetes (CFRD). Over a 10-day period, 30 participants will be monitored remotely, with half receiving overnight tube feeds and the other half receiving daytime feeds. The study focuses on collecting objective data on glucose levels, sleep quality, and circadian rhythms to inform future clinical trials. By minimizing participant burden, the study seeks to generate preliminary data that will help in designing more extensive clinical trials in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 with a known diagnosis of cystic fibrosis-related diabetes who have been on home enteral nutrition for at least three months.
Not a fit: Patients who are blind, deaf, or unable to speak English, as well as those currently using melatonin or with certain skin conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for blood sugar and sleep issues in adults with cystic fibrosis-related diabetes.
How similar studies have performed: While this study explores a specific aspect of CFRD management, similar observational studies have shown promise in understanding the effects of nutrition on metabolic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hassan S Dashti, Ph.D., R.D. — Massachusetts General Hospital
- Study coordinator: Hassan S Dashti, Ph.D., R.D.
- Email: hassan.dashti@mgh.harvard.edu
- Phone: (617) 726-9132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.