Type 1 Diabetes (T1D)T1DREaMNCT06627504
Type 1 Diabetes REst for Metabolic Health
A study testing Sleep Health and Circadian Timing Intervention in people with Type 1 Diabetes (T1D) and Sleep Health, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Sleep Health
- What is being tested?
- Sleep Health and Circadian Timing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- High school students between the ages of 14-19 years;
- Diagnosed with T1D for ≥1 year;
- Using an insulin pump or other automated insulin delivery system;
- Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
- With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Who cannot join
- Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
- Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
- Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
- HbA1c ≥12%;
- Severe illness or DKA within 60 days;
- IQ<70 or severe mental illness impacting sleep or ability to participate in the study;
- Night-shift employment or other obligations that would preclude adherence to the intervention.
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
Children's Hospital Colorado
Aurora, Colorado, 80045
Angel Bernard, BS, 720-777-3491, angel.bernard@childrenscolorado.org
Stacey L Simon, PhD
About this study
Official title: Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).
- Conditions
- Type 1 Diabetes (T1D), Sleep Health
- Being tested
- Sleep Health and Circadian Timing Intervention
- 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 Health and Circadian Timing InterventionBehavioural
Participants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health and Circadian Timing Intervention | Experimental | Participants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses. Receives: Behavioral: Sleep Health and Circadian Timing Intervention |
| Typical Sleep | No intervention | Participants will be asked to sleep on their usual schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Steady-state glucose infusion rate (M) normalized to free fat mass (FFM) and to steady-state insulin (M/I, [mg/kg FFM/min]/insulin) measured with hyperinsulinemic euglycemic clamp
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Cardiovascular Function
Value of central aortic stiffness from cardiovascular MRI
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Glycemic Control
Value of mean sensor glucose assessed with continuous glucose monitor
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Secondary outcomes (3)
Inflammation
Laboratory values of hs-CRP, IL-6, and TNF-alpha
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Adipokines
Laboratory values of leptin and adiponectin
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Cortisol
Laboratory values of cortisol
Measured: Baseline (following 1 month typical sleep) and following 1 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start12 Aug 2025
- Primary completion31 May 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 Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stacey L Simon, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627504
- Sponsor's protocol ID
- 24-1490
- Other IDs
- R01HL174735
- Acronym
- T1DREaM
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All fully deidentified raw and processed/scored data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06627504
- Acronym / sponsor ID
- T1DREaM / 24-1490
- Conditions
- Type 1 Diabetes (T1D), Sleep Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 4 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.
Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Health and Circadian Timing Intervention | Experimental | Behavioral: Sleep Health and Circadian Timing InterventionParticipants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses. |
| Typical Sleep | No intervention | –Participants will be asked to sleep on their usual schedule. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- High school students between the ages of 14-19 years;
- Diagnosed with T1D for ≥1 year;
- Using an insulin pump or other automated insulin delivery system;
- Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
- With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
Key exclusion criteria (7 listed)
- Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
- Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
- Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
- HbA1c ≥12%;
- Severe illness or DKA within 60 days;
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 Health and Circadian Timing InterventionParticipants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses. | Behavioural | Sleep Health and Circadian Timing Intervention |
Primary outcome
Insulin Sensitivity
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Steady-state glucose infusion rate (M) normalized to free fat mass (FFM) and to steady-state insulin (M/I, [mg/kg FFM/min]/insulin) measured with hyperinsulinemic euglycemic clamp
Cardiovascular Function
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Value of central aortic stiffness from cardiovascular MRI
Glycemic Control
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Value of mean sensor glucose assessed with continuous glucose monitor
3 secondary outcomes
Inflammation
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Adipokines
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
Cortisol
Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention
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 3 Jun 2026.
- Individual participant dataSharing planned: Yes. All fully deidentified raw and processed/scored data will be shared.
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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.
Stacey L Simon, PhD principal investigator
University of Colorado, Denver
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 Health and Circadian Timing Intervention in people with Type 1 Diabetes (T1D) and Sleep Health, run by University of Colorado, Denver 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 6 inclusion and 7 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 3 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 Angel Bernard, BS (720-777-3491, angel.bernard@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline (following 1 month typical sleep) and following 1 month intervention). 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 3 Jun 2026.