Sleep and Circadian Intervention for Type 1 Diabetes

(T1DREaM Trial)

Recruiting at 1 trial location

Overseen By Angel Bernard, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Stimulants, Antipsychotics, Sleep aids, Steroids

Disqualifiers: Sleep disorders, HbA1c ≥12%, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether better sleep habits can improve heart and blood sugar health in teens with type 1 diabetes who usually sleep less than seven hours on school nights. Participants will adopt a new sleep routine that adds at least an hour of sleep each night, using melatonin and light therapy. The goal is to determine if this approach, called the Sleep Health and Circadian Timing Intervention, can enhance insulin sensitivity, blood sugar control, and heart health. Teens with type 1 diabetes who sleep less than seven hours on school nights and use an insulin pump might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative sleep interventions that could improve overall health in teens with type 1 diabetes.

Will I have to stop taking my current medications?

The trial requires that participants do not regularly use medications affecting sleep or insulin resistance, such as stimulants, sleep aids, or certain diabetes medications. If you are taking these, you may need to stop before joining the study.

What prior data suggests that this sleep and circadian intervention is safe for adolescents with type 1 diabetes?

Research has shown that sleep and body clock treatments are generally safe. These methods aim to improve sleep habits and synchronize the internal clock. Participants in this study will go to bed earlier, take melatonin, and receive morning sunlight. Melatonin, a natural hormone, aids sleep. Studies indicate these methods are well-tolerated, and melatonin, especially in low doses like 500 micrograms, rarely causes side effects. Light therapy glasses are also usually safe. As this study focuses on adjusting sleep and light exposure, the risks remain low. Most people find these changes manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Health and Circadian Timing Intervention for type 1 diabetes because it takes a novel approach by focusing on sleep patterns and light exposure rather than traditional glucose monitoring and insulin therapy. Unlike standard treatments that primarily manage blood sugar levels, this intervention aims to improve overall metabolic health through better sleep hygiene. By prescribing an extended sleep schedule, melatonin supplementation, and light therapy, the treatment seeks to optimize circadian rhythms, which could potentially enhance insulin sensitivity and glucose metabolism. This new method could offer a complementary strategy to existing diabetes care, potentially improving quality of life for individuals with type 1 diabetes.

What evidence suggests that this sleep and circadian intervention is effective for improving cardiometabolic health in adolescents with type 1 diabetes?

Research has shown that better sleep and regular sleep patterns can help people with type 1 diabetes (T1D) manage their blood sugar levels more effectively. Studies have found that improving sleep can lead to better blood sugar control and reduce diabetes-related stress. Early findings suggest that addressing sleep issues could enhance overall diabetes management. This trial will compare two approaches: one group will maintain their typical sleep schedule, while another will participate in a Sleep Health and Circadian Timing Intervention. By focusing on better sleep and regular sleep schedules, there is potential for improved insulin use and heart health, both crucial for managing diabetes. ^{3 4 5 6 7}

Who Is on the Research Team?

Stacey L Simon, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adolescents with Type 1 Diabetes who usually get less than 7 hours of sleep on school nights. They should be interested in trying to improve their heart health and blood sugar control by changing their sleep habits.

Inclusion Criteria

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)

I am a high school student aged between 14 and 19.

Exclusion Criteria

Night-shift employment or other obligations that would preclude adherence to the intervention

I have been diagnosed with a sleep disorder or scored high for sleep apnea on a specific test.

I regularly take medication that affects my sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Typical Sleep

Participants will be asked to sleep on their usual schedule for one month

4 weeks

Sleep Health and Circadian Timing Intervention

Participants will follow a prescribed sleep schedule with increased time in bed, melatonin, and light therapy

4 weeks

Follow-up

Participants are monitored for changes in insulin sensitivity, glycemic control, and vascular function

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Health and Circadian Timing Intervention

Trial Overview The study tests if getting more sleep and adjusting the body's internal clock can help teens with Type 1 Diabetes. It involves an extra hour or more in bed, taking melatonin in the evening, and morning light therapy compared to their normal routine.

How Is the Trial Designed?

Group I: Sleep Health and Circadian Timing Intervention Experimental Treatment 1 Intervention

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.

Group II: Typical Sleep Active Control 1 Intervention

Participants will be asked to sleep on their usual schedule.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Collaboration between sleep/circadian researchers and metabolism/diabetes experts is essential to translate basic research findings into practical strategies for improving metabolic health, particularly in the context of sleep disruption.

There is a significant opportunity to explore the effects of CPAP treatment for obstructive sleep apnea on pre-diabetes and the impact of temporal restricted feeding on obesity, which could lead to new preventative measures against diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Arble, DM., Bass, J., Behn, CD., et al.[2022]

This study will evaluate the effectiveness of a sleep optimization intervention (Sleep-Opt) in improving sleep quality and glycemic control in 120 adults with type 1 diabetes over 12 weeks, focusing on sleep variability, duration, and A1C levels.

The Sleep-Opt intervention combines technology-assisted behavioral strategies, including a wearable sleep tracker and a smartphone app, aiming to enhance self-management behaviors and overall quality of life for individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Martyn-Nemeth, P., Duffecy, J., Quinn, L., et al.[2023]

An ongoing study is examining the relationship between sleep deficiency and glycemic control in 40 emerging adults with Type 1 Diabetes (T1D), using methods like wrist-worn actigraphy and continuous glucose monitoring over 14 days.

The study aims to develop a tailored sleep self-management intervention that could potentially improve sleep quality, neurocognitive function, and diabetes management, addressing the low glycemic control rates in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, self-management, neurocognitive function, and glycemia in emerging adults with Type 1 diabetes mellitus: A research protocol. Griggs, S., Redeker, NS., Crawford, SL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9694979/

Sleep and Circadian Rhythm Disturbances in Diabetes Preliminary data suggest that treatment of sleep and circadian rhythm disturbances could improve diabetes outcomes in people with T1D and T2D.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125001225

A Randomized Pilot Sleep and Circadian Behavior Clinical ... The cognitive behavioral sleep and circadian intervention improved glycemic outcomes and reduced diabetes distress.

3. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2025.2522680?src=

A Randomized Pilot Cognitive Behavioral Sleep Health ... Young adults with type 1 diabetes (T1D) have poor sleep health, including lower satisfaction and daytime alertness, inconsistent regularity ...

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-11-2024-cd678

Sleep and Circadian Intervention for Type 1 Diabetes Research suggests that improving sleep and circadian rhythms can help manage type 1 diabetes better by enhancing glycemic control (blood sugar levels) and ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06565-6

Sleep optimization to improve glycemic control in adults with ... The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595978/

A Randomized Pilot Sleep and Circadian Behavior Clinical ... Aims: To investigate the preliminary efficacy of a cognitive behavioral sleep and circadian intervention on glycemic and psychological outcomes ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07203196

Circadian Health Regulation and Optimization for ... In this study, the investigators are interested in evaluating the effects of modifying eating, activity and sleeping patterns on age related ...