Cystic Fibrosis Related DiabetesNCT06700889
Investigating the Relationship Between Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
An observational study of Cystic Fibrosis Related Diabetes and Hyperglycaemia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cystic Fibrosis Related Diabetes, Hyperglycaemia, Insomnia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 8 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the 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.
- 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
- Medical subject headings
- Hyperglycemia, Sleep Initiation and Maintenance Disorders, Chronobiology Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (18)
Enrollment Rate
Feasibility measure, assessing the number of participants who successfully enroll.
Measured: Through study completion, an average of 1 year
Percentage of time glucose levels
Percentage of time glucose levels are within 70-180 mg/dL, derived from CGM.
Measured: 10 days
Number of CGM Days
Total number of days with usable CGM data collected across participants.
Measured: 10 days
Number of Actigraphy Days
Total number of days with usable actigraphy data collected across participants.
Measured: 10 days
Number of Completed At-Home Kits (HbA1c)
Total number of at-home HbA1c kits successfully completed and returned.
Measured: 10 days
Total number of days with usable food records collected across participants.
Total number of days with usable food records collected across participants.
Measured: 10 days
Percentage of Time Above Range (>180 mg/dL)
Percentage of time glucose levels are above 180 mg/dL, derived from CGM.
Measured: 10 days
Time Below Range (<54 mg/dL)
Percentage of time glucose levels fall below 54 mg/dL, derived from CGM.
Measured: 10 days
Mean Glucose
Average glucose level across the study period, derived from CGM.
Measured: 10 days
Glucose Variability
Variability in glucose levels, including standard deviation and coefficient of variability, derived from CGM.
Measured: 10 days
Number of Awakenings
Total number of awakenings during the sleep period, measured by actigraphy.
Measured: 10 days
Wake After Sleep Onset (WASO)
Total time in minutes spent awake after initially falling asleep, measured by actigraphy.
Measured: 10 days
Sleep Efficiency
Ratio of sleep duration to time in bed, expressed as a percentage, measured by actigraphy.
Measured: 10 days
Sleep Latency
Time taken to fall asleep after going to bed, measured by actigraphy.
Measured: 10 days
Intradaily Stability
A measure of consistency in daily activity patterns, derived from actigraphy.
Measured: 10 days
Interdaily Variability
A measure of day-to-day variability in activity patterns, derived from actigraphy.
Measured: 10 days
Daily Energy Intake
Total daily caloric intake derived from food records.
Measured: 4 days
Healthy Eating Index
Indicator of dietary quality derived from food records.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start18 Nov 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trustees of Dartmouth College, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Hassan Dashti, Massachusetts General Hospital
- Investigators
- Hassan S Dashti, Ph.D., R.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700889
- Sponsor's protocol ID
- 2024P000762
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
- ClinicalTrials.gov ID
- NCT06700889
- Acronym / sponsor ID
- 2024P000762
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Trustees of Dartmouth College, Harvard Medical School (HMS and HSDM)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
18 secondary outcomes
Enrollment Rate
Time frame: Through study completion, an average of 1 year
Percentage of time glucose levels
Time frame: 10 days
Number of CGM Days
Time frame: 10 days
Number of Actigraphy Days
Time frame: 10 days
Number of Completed At-Home Kits (HbA1c)
Time frame: 10 days
Total number of days with usable food records collected across participants.
Time frame: 10 days
Percentage of Time Above Range (>180 mg/dL)
Time frame: 10 days
Time Below Range (<54 mg/dL)
Time frame: 10 days
Mean Glucose
Time frame: 10 days
Glucose Variability
Time frame: 10 days
Number of Awakenings
Time frame: 10 days
Wake After Sleep Onset (WASO)
Time frame: 10 days
Sleep Efficiency
Time frame: 10 days
Sleep Latency
Time frame: 10 days
Intradaily Stability
Time frame: 10 days
Interdaily Variability
Time frame: 10 days
Daily Energy Intake
Time frame: 4 days
Healthy Eating Index
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Rally \| Cystic Fibrosis Related Diabetes and Tube FeedingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan S Dashti, Ph.D., R.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis Related Diabetes and Hyperglycaemia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.