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Sleep Optimization for Type 1 Diabetes (SOPT Trial)
SOPT Trial Summary
This trial found that the sleep intervention Sleep-Opt improved sleep and glycemic control in working-age adults with type 1 diabetes, which could lead to reduced development of diabetes complications and improved quality of life.
SOPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SOPT Trial Design
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Who is running the clinical trial?
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- I am between 18 and 65 years old.Wanting to improve sleep.I do not have major health issues like heart failure, severe lung disease needing oxygen, active cancer treatment, serious depression, or stroke effects.I have been diagnosed with type 1 diabetes for at least a year.I work night shifts or rotating shifts.You have inconsistent sleep patterns or regularly sleep less than 6.5 hours per night during the workweek, as confirmed by a special sleep watch.Wanting to improve sleep.I have had a severe low blood sugar episode that caused me to pass out in the last 6 months.I have trouble sleeping.Your A1C level is higher than 10%.You have inconsistent sleep patterns or sleep less than 6.5 hours per night during workdays.You are likely to have a condition called obstructive sleep apnea that can affect your breathing during sleep.You have a smartphone.I have been diagnosed with type 1 diabetes for at least one year.I use sleep medications or aids.My kidney function is reduced.
- Group 1: Healthy Living
- Group 2: Sleep-Opt
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this experimental research open to individuals aged 55 and up?
"This clinical trial has an age restriction. The lower limit is 18 and the upper boundary for eligibility is 65 years old."
How many participants are being included in this research effort?
"Affirmative. Clinicaltrials.gov lists this medical trial as actively recruiting, which began on January 19th 2021 and lastly edited on March 13th 2022. 144 participants are required to enter the study at a single locale."
What goals are researchers hoping to achieve with this clinical trial?
"This medical investigation, to be assessed between the initial and six-week, twelve-week, and two year marks explores sleep duration as its primary endpoint. Secondary metrics include mood (as measured by CESD), diabetes distress (assessed through T1DSS) and fatigue adjudicated with PROMIS)."
Are persons from the public eligible to be a part of this research endeavor?
"Affirmative. According to information available on clinicaltrials.gov, this medical trial is actively recruiting patients with the first posting date being January 19th 2021 and the most recent update occurring March 13th 2022. In total, 144 individuals are needed from a single centre."
What are the eligibility requirements for participating in this research project?
"This medical trial requires 144 volunteers, who must meet the following criteria: between 18 and 65 years of age, diagnosed with type 1 diabetes mellitus, demonstrate habitual sleep variances (at least one hour in a week) or inadequate rest during work-/weekdays as recorded by an actigraphy watch, have a goal to improve their sleeping patterns and own a smartphone."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Illinois Chicago: < 48 hours
Average response time
- < 2 Days
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