Investigating the Relationship Between Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
1 other identifier
observational
30
1 country
1
Brief Summary
The goal of this at-home, remote study is to understand the relationship between blood sugars and sleep in adults living with Cystic Fibrosis Related Diabetes (CFRD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2026
CompletedJanuary 9, 2026
January 1, 2026
1.1 years
November 18, 2024
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion Rate
Primary feasibility measure, defined by the completion of all study procedures and the return of study devices after the 10-day study period.
10 days
Secondary Outcomes (18)
Enrollment Rate
Through study completion, an average of 1 year
Percentage of time glucose levels
10 days
Number of CGM Days
10 days
Number of Actigraphy Days
10 days
Number of Completed At-Home Kits (HbA1c)
10 days
- +13 more secondary outcomes
Study Arms (2)
HEN group
This group will include participants who habitually use home enteral nutrition (HEN).
No HEN Group
This group will include participants who do not use home enteral nutrition (HEN).
Eligibility Criteria
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.
You may qualify if:
- Adult men or non-pregnant women volunteers (age 18-79) Able and willing to give consent and comply with procedures 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Trustees of Dartmouth Collegecollaborator
- Harvard Medical School (HMS and HSDM)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hassan S Dashti, Ph.D., R.D.
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 22, 2024
Study Start
November 18, 2024
Primary Completion
January 8, 2026
Study Completion
January 8, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
We do not plan to share Individual Participant Data (IPD) with other researchers as the information collected, which includes detailed glucose profiles, sleep patterns, and circadian rhythm data from individuals with CFRD, is classified as protected health information.