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

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program called Sleep-Opt that uses sleep trackers, phone coaching, and educational content to help adults with type 1 diabetes improve their sleep and blood sugar levels. The study focuses on adults aged 18-65 who have trouble sleeping. By improving sleep, the program aims to enhance blood sugar control and reduce diabetes-related complications.

Research Team

Pamela Martyn-Nemeth, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+