ClinConnect ClinConnect Logo
Search / Trial NCT05823142

Self-Management in Young Adults With Type 1 Diabetes 2023

Launched by CASE WESTERN RESERVE UNIVERSITY · Apr 19, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "Self-Management in Young Adults With Type 1 Diabetes 2023," is examining how improving sleep health can help young adults with Type 1 diabetes (T1D) manage their condition better. The trial is focused on people aged 18 to 31 who have had T1D for at least a year and do not currently meet their blood sugar control targets. Researchers want to see if a 12-week program that teaches good sleep habits can improve sleep quality and, in turn, help with blood sugar levels and feelings of distress related to diabetes.

To be eligible for this study, participants should be between 18 and 31 years old, have been diagnosed with T1D for at least a year, and experience at least one issue related to sleep health, such as poor sleep satisfaction or insufficient sleep duration. Participants will receive guidance through sessions that motivate and support them in making positive changes to their sleep habits. This trial is currently recruiting, and it’s a great opportunity for young adults with T1D to potentially improve their health and quality of life through better sleep.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. are between the ages of 18-31 years;
  • 2. have been diagnosed with T1D for at least 1 year (diagnosis confirmed with ICD 10 code + ≥ 2 of the following: \<10 years age at dx, positive autoantibodies \[GAD65, IA2, ICA, ZnT8\], \<30 kg/m2 BMI at dx, diabetes ketoacidosis any time, C-peptide \< 0.8 ng/mL + associated glucose \>80 mg/dL, family history of 1st degree relative);
  • 3. are not currently participating in intervention studies;
  • 4. read/speak English,
  • 5. have ≥ 1 poor sleep health dimensions (satisfaction: PROMIS \> 56; alertness: ESS \> 7.5; timing/regularity: \>1 hour variability in bed or waketimes; efficiency: \<85%; or duration: \< 7 hours).
  • 6. treated sleep apnea and willingness to continue treatment for intervention (\>80% adherence),
  • 7. not achieving glycemic targets (defined as A1C ≥ 7%, or CGM derived glucose management indicator ≥ 7% or ≤ 80% time in glucose range).
  • Exclusion Criteria:
  • 1. those with major chronic complex medical conditions (heart failure, GFR \< 45 using creatinine, frequent visits for chronic management);
  • 2. severe psychiatric illness (e.g., bipolar, schizophrenia);
  • 3. current pregnancy;
  • 4. recent or planned night shift work or trans-meridian travel;
  • 5. Unable to complete protocol (e.g., bereavement, currently homeless) and
  • 6. known history of untreated sleep apnea (obstructive or central).

About Case Western Reserve University

Case Western Reserve University (CWRU) is a leading research institution located in Cleveland, Ohio, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, CWRU integrates expertise from various fields, including medicine, engineering, and social sciences, to address complex health challenges. The university's clinical trial initiatives are designed to foster the development of novel therapies and interventions, ensuring rigorous scientific methodologies and ethical standards are upheld. CWRU is dedicated to translating research findings into tangible benefits for patients and communities, contributing significantly to the advancement of healthcare practices and policies.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Stephanie Griggs, PhD

Principal Investigator

Case Western Reserve University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported