Sleep Coach for Type 1 Diabetes

Overseen By Lauren Milner, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Serious health conditions, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes (T1D). The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed. We will also explore multiple components of the recently identified central nervous system glymphatic system and evaluate how these components change and impact brain integrity and function with improved sleep.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

How is the Sleep Coach treatment for type 1 diabetes different from other treatments?

The Sleep Coach treatment is unique because it focuses on improving sleep quality in children with type 1 diabetes, which can help manage diabetes better and reduce parental stress. Unlike traditional diabetes treatments that focus on blood sugar control, this intervention targets sleep disturbances, which are common in children with type 1 diabetes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Sleep Coach for Type 1 Diabetes?

Research shows that improving sleep through interventions like sleep hygiene education can significantly enhance sleep quality in children with Type 1 Diabetes, suggesting that similar sleep-focused treatments may help manage diabetes better. ^{1 4 5 6 7}

Who Is on the Research Team?

Sarah Jaser, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 11-17 with Type 1 Diabetes who usually sleep less than 8 hours on school nights and have had diabetes for at least a year. They should not be meeting their HbA1c targets and must not have other sleep disorders or sleep apnea.

Inclusion Criteria

I usually get less than 8 hours of sleep on school nights but don't have sleep disorders.

I am between 11 and 17 years old.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including surveys and sleep diary completion

1 week

1 visit (in-person)

Treatment

Participants receive either the Sleep Coach intervention or Enhanced Usual Care

12 months

3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Coach

Trial Overview The study tests whether a 'Sleep Coach' program can improve how long and well teenagers with Type 1 Diabetes sleep, and if better sleep helps with brain function and blood sugar control. Participants will also learn about managing diabetes.

How Is the Trial Designed?

Group I: Sleep-Promoting Intervention Experimental Treatment 1 Intervention

Individualized sleep-promoting program for adolescents with type 1 diabetes

Group II: Enhanced Usual Care Active Control 1 Intervention

Educational Materials

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A study involving 46 children with Type 1 Diabetes Mellitus showed that sleep hygiene education significantly improved sleep quality, with a notable difference in scores before and after the intervention (p < 0.001).

The intervention group, which received 10 minutes of sleep hygiene education and applied it for 3 days, had a significant improvement in sleep quality compared to the control group, indicating that sleep hygiene practices can be an effective nursing intervention for managing sleep disorders in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Sleep Hygiene Education on Sleep Quality in Children with Type 1 Diabetes Mellitus: A Preliminary Study. Tumakaka, GYS., Agustini, N., Nurhaeni, N., et al.[2019]

Sleep quality significantly affects glycemic control, diabetes self-management, and mental health in individuals with type 1 diabetes, highlighting its importance in overall health care.

While diabetes technologies like hybrid closed-loop systems can enhance nocturnal glycemic regulation and improve subjective sleep quality, objective assessments show minimal changes in sleep duration, indicating that sleep disruptions remain a challenge for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Friend or Foe: a Narrative Review of the Impact of Diabetes Technology on Sleep. Cobry, EC., Karami, AJ., Meltzer, LJ.[2023]

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]

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 (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]

In a study involving 49 children aged 6-13 years with type 1 diabetes, the use of the Tandem Control-IQ hybrid closed-loop system significantly improved parental sleep quality, with 27 parents transitioning from poor to good sleepers.

Improvements in parental sleep were associated with better nocturnal glycemic control in children, indicating a potential link between parental well-being and the management of diabetes in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System. Cobry, EC., Bisio, A., Wadwa, RP., et al.[2023]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The Effect of Sleep Hygiene Education on Sleep Quality in Children with Type 1 Diabetes Mellitus: A Preliminary Study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Friend or Foe: a Narrative Review of the Impact of Diabetes Technology on Sleep. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes. [2021]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Brief report: Sleep disturbances in young children with type 1 diabetes. [2018]