Sleep Optimization for Type 1 Diabetes

(SOPT Trial)

Overseen By Sirimon Reutrakul, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Sleep medications

Disqualifiers: Insomnia, Sleep apnea, Severe hypoglycemia, others

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

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adults with type 1 diabetes sleep better to improve blood sugar control and overall health. It involves two groups: one using a new sleep program called Sleep-Opt, which includes wearable sleep tracking, phone coaching, and helpful tips, and another focusing on healthy living habits. The goal is to determine if better sleep can lead to fewer diabetes-related problems and an improved quality of life. Individuals with type 1 diabetes for at least a year, who typically sleep less than 6.5 hours on workdays or have irregular sleep patterns, and who wish to improve their sleep, might be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative sleep solutions for better diabetes management.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who use sleep medications or aids.

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

Research has shown that the Sleep-Opt treatment is generally safe and easy to use. In a study with 14 participants, those who used Sleep-Opt experienced improved sleep and better control of their blood sugar levels. The study reported no major safety issues, suggesting that Sleep-Opt is a safe option for adults with type 1 diabetes seeking to enhance their sleep and overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for managing Type 1 Diabetes focus on insulin therapy and blood sugar monitoring. However, researchers are excited about the Sleep-Opt method because it takes a fresh approach by focusing on improving sleep quality through self-monitoring, goal setting, and motivational enhancement. Unlike standard diabetes care, which doesn't typically address sleep, Sleep-Opt aims to optimize sleep as a means to improve overall diabetes management. This novel approach could lead to better blood sugar control and quality of life for individuals with Type 1 Diabetes.

What evidence suggests that this trial's treatments could be effective for improving sleep and glycemic control in adults with type 1 diabetes?

This trial tests the Sleep-Opt program as a potential method to improve sleep and blood sugar control in adults with type 1 diabetes. Research has shown that programs focusing on sleep and the body's internal clock can enhance blood sugar levels and reduce diabetes-related stress. The Sleep-Opt program employs wearable devices and coaching to enhance sleep quality. Improved sleep may reduce diabetes complications and enhance quality of life. Although Sleep-Opt is still under evaluation in this trial, early results suggest it could be promising for managing type 1 diabetes. ^{2 4 5 6 7}

Who Is on the Research Team?

Pamela Martyn-Nemeth, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with type 1 diabetes who've had it for at least a year. They should have irregular sleep or get less than 6.5 hours of sleep on workdays, want to improve their sleep, and own a smartphone. It's not for those with recent severe hypoglycemia, night shift workers, pregnant women, insomnia sufferers, those on sleep meds, with renal issues or serious other diseases.

Inclusion Criteria

Own a smartphone

Wanting to improve sleep.

I have been diagnosed with type 1 diabetes for at least a year.

Exclusion Criteria

I do not have major health issues like heart failure, severe lung disease needing oxygen, active cancer treatment, serious depression, or stroke effects.

I work night shifts or rotating shifts.

Breast feeding, pregnant, or planning pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Run-in

Baseline measures of sleep by actigraphy, glycemia, and other secondary outcomes are collected

1 week

Treatment

Participants undergo a 12-week intervention with either Sleep-Opt or healthy living program

12 weeks

Weekly telephone contact

Follow-up

Participants are monitored for sustainability of the intervention effects

12 weeks

Assessments at Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Living
• Sleep-Opt

Trial Overview The study tests 'Sleep-Opt', an intervention combining wearable tech to track sleep patterns, phone coaching sessions and educational materials aimed at enhancing the quality of sleep and blood sugar control in people with type 1 diabetes.

How Is the Trial Designed?

Group I: Sleep-Opt Experimental Treatment 1 Intervention

12-week intervention that includes self-monitoring, goal setting, motivational enhancement.

Group II: Healthy Living Active Control 1 Intervention

12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. 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 ...

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. nursing.uic.edu nursing.uic.edu/research/sleep-optimization-to-improve-glycemic-control-in-adults-with-type-1-diabetes/

Sleep optimization to improve glycemic control in adults with ... Sleep-Optimize could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes. Principal Investigator ...

4. reporter.nih.gov reporter.nih.gov/project-details/10609006

Sleep optimization to improve glycemic control in adults with ... We propose a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep ...

5. 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. In contrast, the control ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9983445/

Sleep-Opt-In: A Randomized Controlled Pilot Study to ... In the full group of 14 participants, those in the Sleep-Opt-In group demonstrated an improvement in sleep regularity, glycemic variability (CV ...

7. 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 ...