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Self-Management in Young Adults With Type 1 Diabetes

NCT04975230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-01-12

Study results available
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Summary

Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population.

The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.

Conditions

Interventions

BEHAVIORAL

Sleep Self-Management

Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Stephanie Griggs, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2023-10-31
Completion
2023-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975230 on ClinicalTrials.gov