What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy can lead to side effects such as hypoglycemia, weight gain, and injection site reactions. Continuous glucose monitoring may cause skin irritation or discomfort at the sensor site. The Sleep-Opt trial, which focuses on sleep optimization using wearable sleep tracking technology, telephone coaching, and informational content, aims to improve glycemic control and quality of life. While sleep optimization itself does not have direct side effects, it can indirectly benefit glycemic control and reduce diabetes-related complications.

What prior FDA approvals exist?

There are no specific FDA approvals for treatments in Type 1 Diabetes that directly align with the Sleep-Opt trial's focus on wearable sleep tracking technology, telephone coaching, and informational content. However, the FDA has approved various technologies and medications for managing Type 1 Diabetes, such as continuous glucose monitors (CGMs) and insulin pumps, which help in maintaining glycemic control. These technologies, while not identical, share a common goal of improving diabetes management through advanced monitoring and patient education.

What other types of research exist?

Promising alternatives to Sleep-Opt for Type 1 Diabetes patients include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown efficacy in improving sleep quality and reducing insomnia symptoms through online platforms. 2) Continuous Glucose Monitoring (CGM) systems integrated with sleep tracking features, providing real-time data to optimize both sleep and glycemic control. 3) Bright Light Therapy, which can help regulate circadian rhythms and improve sleep quality, potentially benefiting glycemic control. 4) Mobile health applications that combine sleep hygiene education, personalized feedback, and real-time monitoring to enhance sleep and manage diabetes more effectively.

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Sleep Optimization for Type 1 Diabetes (SOPT Trial)

N/A

Waitlist Available

Led By Pamela Martyn-Nemeth, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18-65 years

Be older than 18 years old

Must not have

Significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits)

Severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from week. 6, 12, 24

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on lifestyle changes rather than medication there are no direct side effects like you'd expect from drugs; however participants may experience changes in sleeping habits as they adjust to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a severe low blood sugar episode that caused me to pass out in the last 6 months.

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I use sleep medications or aids.

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My kidney function is reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from week. 6, 12, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from week. 6, 12, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week. 6, 12, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic control

Sleep duration

Sleep variability

Secondary study objectives

Diabetes distress

Fatigue

Mood

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep-OptExperimental Treatment1 Intervention

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

Group II: Healthy LivingActive Control1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1DM) include insulin therapy, continuous glucose monitoring (CGM), and interventions like Sleep-Opt. Insulin therapy involves administering exogenous insulin to regulate blood glucose levels. CGM systems provide real-time glucose readings, enabling timely insulin adjustments. The Sleep-Opt intervention, which uses wearable sleep tracking technology, telephone coaching, and informational content, aims to improve sleep quality and glycemic control. Improved sleep can reduce stress and inflammation, positively impacting blood glucose levels. These treatments are essential for T1DM patients as they help maintain optimal glycemic control, reducing the risk of complications and enhancing overall quality of life.

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).Sleep quality and glycaemic variability in a real-life setting in adults with type 1 diabetes.Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial.