Sleep Intervention for Type 1 Diabetes

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a sleep improvement plan for young people with type 1 diabetes. The goal is to determine if doctors can easily implement this sleep program and follow up with their patients over time. It targets teens with type 1 diabetes who visit the Barbara Davis Center and use a continuous glucose monitor. Those with an undiagnosed or untreated sleep disorder may not be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance sleep and diabetes management for young people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that sleep treatments for people with type 1 diabetes are generally safe. In one small study, participants using a sleep improvement program reported better sleep without major side effects. Another study examined sleep coaching for teenagers with type 1 diabetes and found it helped them sleep longer, also without significant negative effects.

Overall, these studies indicate that sleep treatments are well-tolerated. No reports of serious side effects suggest these treatments are safe for most participants in these studies.12345

Why are researchers excited about this trial?

Unlike the standard approach for managing Type 1 Diabetes, which often focuses on insulin therapy and blood sugar monitoring, this sleep intervention targets the unique relationship between sleep and diabetes management. This treatment is unique because it aims to enhance sleep patterns, which can improve overall glucose control and reduce the risk of complications. Researchers are excited about this trial because it explores a non-invasive way to support adolescents in managing their diabetes, potentially leading to better long-term health outcomes through improved rest.

What evidence suggests that this sleep intervention is effective for type 1 diabetes?

Research has shown that sleep programs can benefit teenagers with type 1 diabetes (T1D). One study found that teens in a sleep coaching program gained an average of 48 extra minutes of sleep, leading to improved sleep quality. Other studies suggest that better sleep can aid in controlling blood sugar levels, which is crucial for managing T1D. Regular sleep might also lower the risk of diabetes-related complications, enhancing overall quality of life. In this trial, all enrolled adolescents will participate in a sleep intervention to assess its impact on managing T1D.34678

Who Is on the Research Team?

EC

Erin Cobry, MD

Principal Investigator

University Of Colorado, Barbara Davis Center

Are You a Good Fit for This Trial?

This trial is for adolescents with type 1 diabetes who are receiving care at the Barbara Davis Center. Participants must be young people diagnosed with type 1 diabetes.

Inclusion Criteria

* Receiving care at the Barbara Davis Center
* Type 1 diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Intervention

Adolescents complete a sleep screening questionnaire and, if positive, an in-depth questionnaire to identify sleep barriers. Health care providers address these during the clinic visit.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for intervention completion, retention, and follow-through at 3 months. Those who did not screen positive complete a follow-up sleep screener.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep intervention

Trial Overview

The study is testing a sleep screening and intervention program to help improve sleep in teens with type 1 diabetes. The goal is to see if this approach works well in a real clinic setting.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sleep InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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