Sleep Stability Intervention for Type 1 Diabetes

Overseen By Pamela Martyn-Nemeth, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Sleep medications

Disqualifiers: Severe hypoglycemia, Depression, Insomnia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how improving sleep regularity might benefit people with type 1 diabetes by helping control blood sugar and reduce heart disease risk. The treatment involves a sleep stability intervention, aiming to make sleep schedules more consistent. Participants should have had type 1 diabetes for at least a year, experience irregular sleep of one hour or more each week, and want to improve their sleep. Participants should also own a smartphone.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep and overall health.

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.

What prior data suggests that this sleep stability intervention is safe for people with type 1 diabetes?

Studies have not provided specific safety data for the Sleep Stability Intervention. However, the trial's "Not Applicable" phase label suggests the intervention is likely non-invasive and carries minimal risk. Sleep interventions typically focus on adjusting sleep patterns and habits, which are considered safe. No reports of severe adverse events have been linked to this type of treatment. Prospective participants should know that sleep interventions are usually well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Type 1 Diabetes focus on managing blood sugar levels through insulin therapy and lifestyle adjustments, including diet and exercise. However, the sleep stability intervention is unique because it targets the regulation of sleep patterns, which can significantly impact blood sugar control. Researchers are excited about this approach because stabilizing sleep may improve glucose metabolism and overall diabetes management without directly altering insulin levels. This method could offer a new dimension to diabetes care, potentially enhancing the effectiveness of existing treatments.

What evidence suggests that this sleep stability intervention is effective for type 1 diabetes?

Research has shown that improving sleep can help people with type 1 diabetes manage their blood sugar levels more effectively. Studies have found a link between good sleep and more stable blood sugar. For example, efforts to enhance sleep quality and duration can lead to better diabetes management. Good sleep is also associated with a lower risk of heart problems, which are more common in people with type 1 diabetes. Overall, focusing on better sleep habits may aid in managing diabetes and reducing related health risks. Participants in this trial will receive a sleep stability intervention to explore these potential benefits. ^{6 7 8 9 10}

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

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?

Group I: Single arm Experimental Treatment 1 Intervention

Sleep stability intervention

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

In a study of 86 children and adolescents with type 1 diabetes, those with higher glycated hemoglobin (HbA1c) levels (≥7.5%) experienced more daytime sleepiness and shorter sleep duration during the week.

The research found that a shorter duration since diagnosis of type 1 diabetes also increased the likelihood of daytime sleepiness, indicating that both poor glycemic control and recent diagnosis may negatively impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. Silva, RAE., Ganen, AP., Fernandes, VFT., et al.[2021]

The study found significant sleep disturbances and insufficient sleep duration in young children aged 3-5 with type 1 diabetes, indicating a potential area of concern for their overall health.

Improving sleep quality may not only enhance diabetes management in these children but also reduce parental distress, suggesting that sleep interventions could be beneficial for both children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: Sleep disturbances in young children with type 1 diabetes. Jaser, SS., Lord, JH., Simmons, JH., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. Perez, KM., Hamburger, ER., Lyttle, M., et al.[2020]

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]

Individuals with type 1 diabetes often experience sleep disruptions due to both behavioral factors and the physiological effects of the disease and its management.

These sleep disturbances can have negative impacts on the progression of diabetes and the development of related complications, emphasizing the importance of addressing sleep quality in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 Diabetes and Sleep. Farabi, SS.[2020]

The study will involve up to 175 adolescents with type 1 diabetes and their caregivers, comparing the effects of a sleep extension intervention against family routines support to improve sleep duration and glycemic control.

It is hypothesized that increasing sleep duration will lead to better glycemic control, measured through continuous glucose monitoring and HbA1c levels, highlighting the importance of sleep in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Perfect, MM., Silva, GE., Chin, CN., et al.[2023]

Adolescents with type 1 diabetes average only 7.4 hours of sleep, which is below the recommended amount for their age, indicating a need for better sleep hygiene.

Those using insulin pumps experienced fewer sleep disturbances and longer sleep duration compared to those using injections, suggesting that the method of insulin delivery may impact sleep quality and, consequently, diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Adolescents and Young Adults with Type 1 Diabetes: Associations with Diabetes Management and Glycemic Control. Jaser, SS., Ellis, D.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes. Jaser, SS., Bergner, EM., Hamburger, ER., et al.[2021]

Citations

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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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04506151

Sleep Optimization to Improve Glycemic Control in Adults ... 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 ...

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945716300351

Sleep characteristics in type 1 diabetes and associations ... T1D was associated with poorer sleep and high prevalence of OSA. Poor sleep quality, shorter sleep duration, and OSA were associated with suboptimal glycemic ...

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

A Randomized Pilot Cognitive Behavioral Sleep Health ... Of the randomized participants, 31 (79.5%) completed the post-intervention, while 33 (84.6%) completed the 3-month follow-up. The CB-Sleep ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389486/

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 ...

7. mdpi.com mdpi.com/2673-4540/6/3/21

Sleep Quality and Glycemic Control in Type 1 Diabetes This study aimed to observe sleep quality in T1D patients and glycemic outcomes, particularly at bedtime hours.

8. withpower.com withpower.com/trial/phase-type-1-diabetes-mellitus-2-2025-095fb

Sleep Stability Intervention for Type 1 Diabetes Is the Sleep Stability Intervention safe for humans? The research articles do not provide specific safety data for the Sleep Stability Intervention, but ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02687893

NCT02687893 | Effect of Hypoglycemia on Sleep Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation.

10. link.springer.com link.springer.com/article/10.1007/s11325-025-03385-1

Poor sleep quality is a predictor of severe hypoglycemia ... Poor sleep quality was reported in 33.0% of participants. A1C levels improved over the one-year follow-up, but there was no significant ...