Sleep and Circadian Intervention for Type 1 Diabetes

(T1DREaM Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Sleep Health and Circadian Timing 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 reducing diabetes-related stress. Studies indicate that better sleep health is linked to achieving blood sugar targets, which implies that addressing sleep issues could be beneficial for people with type 1 diabetes. ^{1 2 3 4 5}

Is the Sleep and Circadian Intervention for Type 1 Diabetes safe for humans?

The research suggests that sleep and circadian interventions are generally safe for humans, as they focus on improving sleep patterns and aligning biological clocks, which can help manage diabetes and other health conditions. However, more research is needed to fully understand their safety and effectiveness in different populations. ^{2 6 7 8 9}

How does the Sleep Health and Circadian Timing Intervention treatment differ from other treatments for type 1 diabetes?

This treatment is unique because it focuses on improving sleep patterns and circadian rhythms (the body's internal clock) to help manage type 1 diabetes, rather than directly targeting blood sugar levels with medication. By addressing sleep disturbances, it aims to improve glycemic control and overall diabetes management, which is a novel approach compared to traditional treatments. ^{1 2 3 10 11}

What is the purpose of this trial?

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 \&lt;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).

Research Team

Stacey L Simon, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association between sleep variability and time in range of glucose levels in patients with type 1 diabetes: Cross-sectional study. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Sleep and Circadian Rhythm Disturbances in Diabetes: A Narrative Review. [2023]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep health dimensions are associated with next-day symptoms in young adults with type 1 diabetes. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A composite measure of sleep health is associated with glycaemic target achievement in young adults with type 1 diabetes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Morning Circadian Misalignment during Short Sleep Duration Impacts Insulin Sensitivity. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Is Being a Lark Healthier for Patients with Type 1 Diabetes Mellitus? [2023]

10. England pubmed.ncbi.nlm.nih.gov

Higher sleep variability is associated with poorer glycaemic control in patients with type 1 diabetes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Sleep, self-management, neurocognitive function, and glycemia in emerging adults with Type 1 diabetes mellitus: A research protocol. [2021]