Type 1 Diabetes (T1D)NCT06624046
Circadian Mechanisms, Glucose, and CV Risks in T1D
A study testing Sleep stability intervention in people with Type 1 Diabetes (T1D), run by University of Illinois Chicago at 1 site in United States.
Trial summary
People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Sleep stability intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18-50 years with a clinical diagnosis of T1D for at least one year
- Report habitual sleep irregularity ≥1 hour/week
- Desire to improve sleep, and own a smartphone (Android or iPhone)
Who cannot join
- Self-reported A1C within the past 6 months ≥10%
- insomnia symptoms defined as Insomnia Severity Index score ≥15
- history of restless leg syndrome
- history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months
- rotating shift or night work or routinely sleeping after 3 AM.
- use of sleep medications/aids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy [dialysis])
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- depression (Patient Health Questionnaire 8 [PHQ-8] score ≥15)
- history of stroke with neurological deficits
- pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.
- Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Pamela Martyn-Nemeth, PhD, 312-996-7903, pmartyn@uic.edu
Sirimon Reutrakul, MD, 312-413-3631, sreutrak@uic.edu
About this study
Official title: Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes
People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.
Read the detailed description
People with type 1 diabetes (T1D) are disproportionately affected by cardiovascular disease (CVD). CVD is a leading cause of death in T1D, contributing to 40% of mortality. Sleep is recognized by both the American Heart Association and the American Diabetes Association as a critical health behavior to maintain glycemic control and reduce CVD risk. Short and/or irregular sleep have been associated with reduced glycemic control and non-dipping blood pressure in T1D, both of which are predictors of CV events. Emerging data suggest that behavioral sleep interventions targeting short or irregular sleep led to improved glycemic parameters. However, little is known about the mechanism by which improving sleep duration and/or regularity improves glycemic control and reduces CV risk in T1D. The investigators and others have shown that people with T1D often experience poor sleep health, including inadequate sleep duration, sleep irregularity, and poor sleep quality. The goals of this study are to examine the mechanisms by which improving sleep regularity through behavioral sleep intervention affects glycemic control and CVD risks in T1D adults. The investigators propose to extend our previous research by conducting a mechanistic study using a sleep stability manipulation. The investigators hypothesize that sleep stability impacts glycemic control and CV outcomes by improving circadian regulation. The investigators will conduct a 4-week behavioral sleep stability intervention in 100 T1D adults with irregular sleep, utilizing a sleep pre/post design. Circadian regulation will be assessed by dim-light melatonin onset (DLMO), melatonin metabolite amplitude (overnight urinary 6-sulfatoxymelatonin levels), actigraphy-derived rest-activity rhythm, endothelial cell CLOCK gene mRNA expression, and known zeitgebers of the central and peripheral circadian clocks (light exposure, meal timing). Main glycemic outcomes will be assessed by CGM, A1C, and assessment of insulin sensitivity. Main CV outcomes will include 24h blood pressure and endothelial FMD and other secondary vascular measures (pulse wave velocity, carotid intima media thickness, and echocardiographic parameters). Sleep will be objectively recorded. All parameters will be measured at baseline and end of intervention. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Sleep stability intervention
- Keywords
- sleep, cardiovascular disease risk, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep stability interventionBehavioural
The sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Sleep stability intervention Receives: Behavioral: Sleep stability intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic status
Continuous glucose monitor (CGM)
Measured: From enrollment to week 12
Glycemic control
Hemoglobin A1C
Measured: From enrollment to week 12
Insulin sensitivity
Insulin sensitivity
Measured: From enrollment to week 12
Secondary outcomes (11)
Circadian regulation DLMO
dim-light melatonin onset (DLMO)
Measured: enrollment to week 12
Circadian regulation Melatonin
Melatonin metabolite amplitude
Measured: Enrollment to week 12
Circadian regulation actigraphy
actigraphy-derived rest activity rhythm
Measured: enrollment to week 12
Circadian regulation CLOCK gene
endothelial cell CLOCK gene mRNA expression
Measured: enrollment to week 12
Circadian regulation light
light exposure
Measured: enrollment to week 12
Circadian regulation meals
Meal timing
Measured: enrollment to week 12
Cardiovascular outcome blood pressure
24 hour blood pressure
Measured: enrollment to week 12
Cardiovascular outcome endothelial function
endothelial flow-mediated dilation
Measured: enrollment to week 12
Cardiovascular outcome arterial stiffness
pulse wave velocity
Measured: enrollment to week 12
Cardiovascular outcome echocardiogram
echocardiogram
Measured: enrollment to week 12
Cardiovascular outcome CIMT
carotid intima lining thickness (CIMT)
Measured: enrollment to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start13 Mar 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, pretest, post-test design using a sleep stability intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Pamela Martyn-Nemeth, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624046
- Sponsor's protocol ID
- 2024-0886
- Other IDs
- R01HL174738
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data identified for sharing will be processed and shared in the UIC institutional repository, INDIGO. Data to be generated include: 1. Biochemical data 2. Body composition 3. Vascular and cardiac measures 4. Fat biopsies to measure circadian CLOCK gene and mRNA expression. 5. Objective sleep and physical activity 6. Demographic and questionnaire data 7. Meal timing, diet composition, and total daily calorie intake will be obtained using a 7-day dietary log (ASA-24). De-identified data noted above will be shared except raw questionnaire data and mp4 vascular and cardiac video recordings
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06624046
- Acronym / sponsor ID
- 2024-0886
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- sleep, cardiovascular disease risk, glycemic control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 2 Oct 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.
People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.
Detailed description
People with type 1 diabetes (T1D) are disproportionately affected by cardiovascular disease (CVD). CVD is a leading cause of death in T1D, contributing to 40% of mortality. Sleep is recognized by both the American Heart Association and the American Diabetes Association as a critical health behavior to maintain glycemic control and reduce CVD risk. Short and/or irregular sleep have been associated with reduced glycemic control and non-dipping blood pressure in T1D, both of which are predictors of CV events. Emerging data suggest that behavioral sleep interventions targeting short or irregular sleep led to improved glycemic parameters. However, little is known about the mechanism by which improving sleep duration and/or regularity improves glycemic control and reduces CV risk in T1D. The investigators and others have shown that people with T1D often experience poor sleep health, including inadequate sleep duration, sleep irregularity, and poor sleep quality. The goals of this study are to examine the mechanisms by which improving sleep regularity through behavioral sleep intervention affects glycemic control and CVD risks in T1D adults. The investigators propose to extend our previous research by conducting a mechanistic study using a sleep stability manipulation. The investigators hypothesize that sleep stability impacts glycemic control and CV outcomes by improving circadian regulation. The investigators will conduct a 4-week behavioral sleep stability intervention in 100 T1D adults with irregular sleep, utilizing a sleep pre/post design. Circadian regulation will be assessed by dim-light melatonin onset (DLMO), melatonin metabolite amplitude (overnight urinary 6-sulfatoxymelatonin levels), actigraphy-derived rest-activity rhythm, endothelial cell CLOCK gene mRNA expression, and known zeitgebers of the central and peripheral circadian clocks (light exposure, meal timing). Main glycemic outcomes will be assessed by CGM, A1C, and assessment of insulin sensitivity. Main CV outcomes will include 24h blood pressure and endothelial FMD and other secondary vascular measures (pulse wave velocity, carotid intima media thickness, and echocardiographic parameters). Sleep will be objectively recorded. All parameters will be measured at baseline and end of intervention. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, pretest, post-test design using a sleep stability intervention
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Behavioral: Sleep stability interventionSleep stability intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults 18-50 years with a clinical diagnosis of T1D for at least one year
- Report habitual sleep irregularity ≥1 hour/week
- Desire to improve sleep, and own a smartphone (Android or iPhone)
Key exclusion criteria (10 listed)
- Self-reported A1C within the past 6 months ≥10%
- insomnia symptoms defined as Insomnia Severity Index score ≥15
- history of restless leg syndrome
- history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months
- rotating shift or night work or routinely sleeping after 3 AM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep stability interventionThe sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol. | Behavioural | Single arm |
Primary outcome
Glycemic status
Time frame: From enrollment to week 12
Continuous glucose monitor (CGM)
Glycemic control
Time frame: From enrollment to week 12
Hemoglobin A1C
Insulin sensitivity
Time frame: From enrollment to week 12
Insulin sensitivity
11 secondary outcomes
Circadian regulation DLMO
Time frame: enrollment to week 12
Circadian regulation Melatonin
Time frame: Enrollment to week 12
Circadian regulation actigraphy
Time frame: enrollment to week 12
Circadian regulation CLOCK gene
Time frame: enrollment to week 12
Circadian regulation light
Time frame: enrollment to week 12
Circadian regulation meals
Time frame: enrollment to week 12
Cardiovascular outcome blood pressure
Time frame: enrollment to week 12
Cardiovascular outcome endothelial function
Time frame: enrollment to week 12
Cardiovascular outcome arterial stiffness
Time frame: enrollment to week 12
Cardiovascular outcome echocardiogram
Time frame: enrollment to week 12
Cardiovascular outcome CIMT
Time frame: enrollment to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data identified for sharing will be processed and shared in the UIC institutional repository, INDIGO. Data to be generated include: 1. Biochemical data 2. Body composition 3. Vascular and cardiac measures 4. Fat biopsies to measure circadian CLOCK gene and mRNA expression. 5. Objective sleep and physical activity 6. Demographic and questionnaire data 7. Meal timing, diet composition, and total daily calorie intake will be obtained using a 7-day dietary log (ASA-24). De-identified data noted above will be shared except raw questionnaire data and mp4 vascular and cardiac video recordings
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep stability intervention in people with Type 1 Diabetes (T1D), run by University of Illinois Chicago 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 10 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: looking for participants now, as of the sponsor's last update on 30 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Martyn-Nemeth, PhD (312-996-7903, pmartyn@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic status (time frame: From enrollment to week 12). The study lists 3 primary outcomes in all. 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 30 Jun 2026.