Evidence map›Paper›PMID 40939736›Full record

ArticleContemporary clinical trials2025

Sleep coach intervention for adolescents with type 1 diabetes: Rationale and trial design.

Sarah S Jaser, Jill Simmons, Lauren L Milner, Charity E Davis, Samantha M Davis, Tabitha C McCarty, Lauren LeStourgeon, Beth A Malow, James C Slaughter, Kashope Anifowoshe and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Sarah S JaserDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Sarah.jaser@vumc.org.
Jill SimmonsDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Lauren L MilnerDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Charity E DavisDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Samantha M DavisDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Tabitha C McCartyDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Lauren LeStourgeonDepartment of Medicine, Division of General Internal Medicine & Public Health, Vanderbilt University Medical Center, Nashville, TN, USA.
Beth A MalowDepartment of Neurology, Sleep Division, Vanderbilt University Medical Center, Nashville, TN, USA.
James C SlaughterDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Kashope AnifowosheDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Lori C JordanDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents with T1DR01DK136695 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Sarah S Jaser, Lori Chaffin Jordan · 2024 to 2026
$2.2M
NCATS NIH HHS UL1 TR002243NIDDK NIH HHS R01 DK136695
6 · The paper itself

Abstract

backgroundDespite improvements in hemoglobin A1c among adolescents with type 1 diabetes (T1D) over the past several years, most are still not meeting recommended glycemic targets, placing them at elevated risk for acute and long-term health complications. Thus, there is a critical need for novel approaches to improve diabetes management in adolescents with T1D. Insufficient and inconsistent sleep affects glycemic outcomes directly through decreased insulin sensitivity, and indirectly via compromised executive function in adolescents, reducing their ability to effectively manage T1D. Via a randomized controlled trial of 150 adolescents (age 11-17 years) with T1D, we will evaluate the effects of a sleep-promoting behavioral intervention that includes individual coaching on sleep duration and timing. We hypothesize that adolescents randomized to the Sleep Coach intervention will exhibit significantly longer sleep duration and reduced sleep variability as compared to those who receive enhanced usual care, consisting of additional diabetes education materials and text messages. Effects of the sleep-promoting intervention on executive function, glycemic outcomes (hemoglobin A1c, Time in Range) and diabetes management will be evaluated.

methodsPrimary outcomes (sleep duration and timing) and secondary outcomes (executive function, assessed with NIH Toolbox measures and caregiver reports, and glycemic outcomes) are assessed over 12 months. Intent-to-treat analysis will be used to evaluate efficacy of the intervention.

conclusionIf efficacious, Sleep Coach has the potential to improve both cognitive and glycemic outcomes in adolescents with T1D. This individualized, interactive, manualized behavioral intervention can be delivered remotely by trained staff, with the potential for wide dissemination.

Indexed as

Diabetes Mellitus, Type 1MentoringSleepAdolescentBlood GlucoseChildExecutive FunctionFemaleGlycated HemoglobinGlycemic ControlHumansIntention to Treat AnalysisMalePatient Education as TopicRandomized Controlled Trials as TopicBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanAdolescentsBehaviorExecutive functionSleepSleep interventionType 1 diabetes

Identifiers

PMID40939736
PMCPMC12724686

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.