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

January 8, 2026 updated by: Hassan Dashti, Massachusetts General Hospital
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).

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion Rate
Time Frame: 10 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: Through study completion, an average of 1 year
Feasibility measure, assessing the number of participants who successfully enroll.
Through study completion, an average of 1 year
Percentage of time glucose levels
Time Frame: 10 days
Percentage of time glucose levels are within 70-180 mg/dL, derived from CGM.
10 days
Number of CGM Days
Time Frame: 10 days
Total number of days with usable CGM data collected across participants.
10 days
Number of Actigraphy Days
Time Frame: 10 days
Total number of days with usable actigraphy data collected across participants.
10 days
Number of Completed At-Home Kits (HbA1c)
Time Frame: 10 days
Total number of at-home HbA1c kits successfully completed and returned.
10 days
Total number of days with usable food records collected across participants.
Time Frame: 10 days
Total number of days with usable food records collected across participants.
10 days
Percentage of Time Above Range (>180 mg/dL)
Time Frame: 10 days
Percentage of time glucose levels are above 180 mg/dL, derived from CGM.
10 days
Time Below Range (<54 mg/dL)
Time Frame: 10 days
Percentage of time glucose levels fall below 54 mg/dL, derived from CGM.
10 days
Mean Glucose
Time Frame: 10 days
Average glucose level across the study period, derived from CGM.
10 days
Glucose Variability
Time Frame: 10 days
Variability in glucose levels, including standard deviation and coefficient of variability, derived from CGM.
10 days
Number of Awakenings
Time Frame: 10 days
Total number of awakenings during the sleep period, measured by actigraphy.
10 days
Wake After Sleep Onset (WASO)
Time Frame: 10 days
Total time in minutes spent awake after initially falling asleep, measured by actigraphy.
10 days
Sleep Efficiency
Time Frame: 10 days
Ratio of sleep duration to time in bed, expressed as a percentage, measured by actigraphy.
10 days
Sleep Latency
Time Frame: 10 days
Time taken to fall asleep after going to bed, measured by actigraphy.
10 days
Intradaily Stability
Time Frame: 10 days
A measure of consistency in daily activity patterns, derived from actigraphy.
10 days
Interdaily Variability
Time Frame: 10 days
A measure of day-to-day variability in activity patterns, derived from actigraphy.
10 days
Daily Energy Intake
Time Frame: 4 days
Total daily caloric intake derived from food records.
4 days
Healthy Eating Index
Time Frame: 4 days
Indicator of dietary quality derived from food records.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Harvard Medical School (HMS and HSDM)
Trustees of Dartmouth College

Investigators

  • Principal Investigator: Hassan S Dashti, Ph.D., R.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Actual)

January 8, 2026

Study Completion (Actual)

January 8, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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