Investigating the Relationship Between Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes

Mass General Brigham

Status: Completed

Conditions: Cardiometabolic Diseases; Hyperglycaemia; Insomnia; Circadian Rhythm Disorders; Cystic Fibrosis Related Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06700889

2024P000762

Details and patient eligibility

About

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).

Full description

The study is a 10-day home-based, observational study of 30 adults with CFRD 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 and to generate preliminary data to power a future clinical trial.

Enrollment: 30 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

30 participants in 2 patient groups

HEN group

Description:

This group will include participants who habitually use home enteral nutrition (HEN).

No HEN Group

Description:

This group will include participants who do not use home enteral nutrition (HEN).