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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how tube feeding affects blood sugar levels and sleep quality in adults who have Cystic Fibrosis Related Diabetes (CFRD). The study aims to improve the understanding of these effects, which can help in managing both diabetes and sleep issues better. It is an at-home study, meaning participants will not need to visit a clinic frequently, making it more convenient for them.

To participate, individuals must be between 18 and 79 years old, have been using tube feeding for at least three months, and have a stable diagnosis of CFRD. They should be able to provide consent and follow the study procedures. Participants can expect to participate remotely, where they’ll monitor their blood sugar and sleep patterns while receiving support from the study team. It’s important to note that people with certain conditions, like untreated sleep disorders or those who are pregnant, cannot participate. If you or a loved one meets the eligibility criteria and is interested in contributing to this important research, consider joining the study!

Gender

ALL

Eligibility 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