80 Participants Needed

Sleep Stability Intervention for Type 1 Diabetes

SR
PM
Overseen ByPamela Martyn-Nemeth, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does exclude those using sleep medications or aids.

Is the Sleep Stability Intervention safe for humans?

The research articles do not provide specific safety data for the Sleep Stability Intervention, but they do discuss sleep-related interventions in people with type 1 diabetes, suggesting that addressing sleep issues is considered important for managing the condition.12345

How does the Sleep Stability Intervention treatment differ from other treatments for type 1 diabetes?

The Sleep Stability Intervention is unique because it focuses on improving sleep patterns to enhance glycemic control in people with type 1 diabetes, rather than directly targeting blood sugar levels with medication. This approach addresses sleep variability and duration, which are linked to better diabetes management and quality of life.678910

What data supports the effectiveness of the sleep stability intervention treatment for type 1 diabetes?

Research suggests that improving sleep can help manage type 1 diabetes better by potentially improving blood sugar control and reducing diabetes-related stress. Although specific data on the sleep stability intervention is limited, studies indicate that better sleep may lead to better diabetes management.167911

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 diabetes who may be experiencing cardiovascular issues due to irregular or insufficient sleep. The study aims to understand how stabilizing sleep patterns can improve heart health and blood sugar control in these patients.

Inclusion Criteria

Report habitual sleep irregularity ≥1 hour/week
I want to sleep better and I own a smartphone.

Exclusion Criteria

Insomnia symptoms defined as Insomnia Severity Index score ≥15
Rotating shift or night work or routinely sleeping after 3 AM
Pregnant, breast feeding, or planning pregnancy
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of glycemic control, cardiovascular outcomes, and circadian regulation are taken

1 week
1 visit (in-person)

Treatment

Participants undergo a 4-week behavioral sleep stability intervention

4 weeks
Weekly check-ins (virtual)

Post-Intervention Assessment

Post-intervention measurements of glycemic control, cardiovascular outcomes, and circadian regulation are taken

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep stability intervention
Trial Overview The intervention being tested is a 'sleep stability' program designed to help participants achieve more regular and consistent sleep patterns, which could potentially lead to better management of their diabetes and reduced risk of cardiovascular disease.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Sleep stability intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

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.
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]
Individuals with type 1 diabetes (T1D) experience more sleep disturbances than those without diabetes, which negatively affects their blood sugar control and overall diabetes management.
Inconsistent sleep timing is linked to poorer glycemic control, suggesting that interventions aimed at improving sleep consistency could enhance diabetes management and psychosocial outcomes for people with T1D.
Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management.Perez, KM., Hamburger, ER., Lyttle, M., et al.[2020]
The Sleep Coach Jr. intervention, which included educational materials and phone support, was found to be feasible and acceptable for 39 parent-child pairs, with high completion rates and satisfaction reported by parents.
While the intervention did not lead to changes in children's sleep or diabetes outcomes, it did improve parental sleep quality and well-being, suggesting potential benefits for parents involved in managing their child's type 1 diabetes.
Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes.Jaser, SS., Bergner, EM., Hamburger, ER., et al.[2021]

Citations

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. [2023]
Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. [2020]
Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes. [2021]
Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. [2022]
Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. [2021]
Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. [2023]
Brief report: Sleep disturbances in young children with type 1 diabetes. [2018]
Type 1 Diabetes and Sleep. [2020]
Subjective sleep disturbances and glycemic control in adults with long-standing type 1 diabetes: The Pittsburgh's Epidemiology of Diabetes Complications study. [2022]
Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Impact of type 1 diabetes mellitus, glucose levels, and glycemic control on sleep in children and adolescents: a case-control study. [2021]
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