Clinical trial NCT06700889: Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
Official title: Investigating the Effects of Tube Feeds on Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis Related Diabetes
Hyperglycaemia
Insomnia
Cardiometabolic Diseases
Circadian Rhythm Disorders
Keywords: Cystic Fibrosis Related Diabetes
Tube Feeds
Circadian Rhythm
Diabetes
Home Enteral Nutrition
Circadian misalignment
Nutrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Trustees of Dartmouth College
name: Harvard Medical School (HMS and HSDM)
First posted: 2024-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis-related diabetes patients living in the US and identified from various sources: Rally website, the MGH Adult CF Program, the CF Foundation EnVision program, and the Oley Foundation.

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.

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

Primary outcomes:
measure: Completion Rate
timeFrame: 10 days
Secondary outcomes:
measure: Enrollment Rate
timeFrame: Through study completion, an average of 1 year
measure: Percentage of time glucose levels
timeFrame: 10 days
measure: Number of CGM Days
timeFrame: 10 days
measure: Number of Actigraphy Days
timeFrame: 10 days
measure: Number of Completed At-Home Kits (HbA1c)
timeFrame: 10 days
measure: Total number of days with usable food records collected across participants.
timeFrame: 10 days
measure: Percentage of Time Above Range (>180 mg/dL)
timeFrame: 10 days
measure: Time Below Range (<54 mg/dL)
timeFrame: 10 days
measure: Mean Glucose
timeFrame: 10 days
measure: Glucose Variability
timeFrame: 10 days
measure: Number of Awakenings
timeFrame: 10 days
measure: Wake After Sleep Onset (WASO)
timeFrame: 10 days
measure: Sleep Efficiency
timeFrame: 10 days
measure: Sleep Latency
timeFrame: 10 days
measure: Intradaily Stability
timeFrame: 10 days
measure: Interdaily Variability
timeFrame: 10 days
measure: Daily Energy Intake
timeFrame: 4 days
measure: Healthy Eating Index
timeFrame: 4 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hassan S Dashti, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References: