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?

This trial explores whether a program called the Sleep Coach can help teens with type 1 diabetes (T1D) manage their condition better. Researchers aim to determine if improved sleep enhances thinking skills and blood sugar control. They will also examine how better sleep might affect brain health. Teens with T1D who lack sufficient sleep and struggle to meet HbA1c targets may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how sleep improvements can benefit teens with T1D.

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.

What prior data suggests that this behavioral intervention is safe for adolescents with type 1 diabetes?

Research has shown that programs like the Sleep Coach can improve sleep for kids with Type 1 Diabetes. In one study, 80% of teens in the Sleep Coach group completed all sessions, and 90% remained in the study. These results suggest the program is easy to follow and safe. No serious side effects have been reported. Instead, participants experienced better sleep, which can aid in managing their diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Coach for Type 1 Diabetes because it offers a personalized approach to improving sleep for adolescents with type 1 diabetes, unlike standard treatments that typically focus on managing blood sugar levels with insulin and lifestyle adjustments. This intervention tailors sleep-promoting strategies to each individual's needs, potentially enhancing diabetes management by improving sleep quality. By addressing sleep issues directly, this method could lead to better overall health outcomes and quality of life for young people with type 1 diabetes, offering a fresh perspective on managing this chronic condition.

What evidence suggests that the Sleep Coach intervention is effective for improving sleep in adolescents with type 1 diabetes?

Studies have shown that the Sleep Coach program, which participants in this trial may receive, can help teens with type 1 diabetes sleep better and longer. Specifically, one study found that teens using this program slept 48 minutes more each night. Better sleep might also enhance thinking, memory, and blood sugar control. Research suggests that more sleep can boost brain function and overall health in children with type 1 diabetes. While results can differ, these findings indicate that the Sleep Coach could be a helpful tool for managing type 1 diabetes by improving sleep. ^{1 2 3 4 6}

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

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32003520/

Sleep coach intervention for teens with type 1 diabetes Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40939736/

Sleep coach intervention for adolescents with type 1 diabetes Conclusion: If efficacious, Sleep Coach has the potential to improve both cognitive and glycemic outcomes in adolescents with T1D. This individualized, ...

3. psycnet.apa.org psycnet.apa.org/record/2021-49201-008

Pilot trial of a sleep-promoting intervention for children with ... Objective: To assess the feasibility and acceptability of an educational sleep-promoting intervention (Sleep Coach Jr.) for school-aged children (ages 5–9) ...

4. researchgate.net researchgate.net/publication/347172706_Pilot_Trial_of_a_Sleep-Promoting_Intervention_for_Children_With_Type_1_Diabetes

Pilot Trial of a Sleep-Promoting Intervention for Children ... No changes were observed in children's sleep or diabetes outcomes, but parental sleep quality and well-being improved. Conclusions A brief, behavioral sleep- ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-9-2024-6c751

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, ...

6. pediatrics.vumc.org pediatrics.vumc.org/publication/sleep-coach-intervention-teens-type-1-diabetes-randomized-pilot-study

Sleep coach intervention for teens with type 1 diabetes Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep ...