Self-Management in Young Adults With Type 1 Diabetes

NCT ID: NCT04975230

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2023-11-01

Brief 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.

Detailed Description

This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to "usual care."

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Sleep Self-Management

The Sleep Self-Management Intervention involves an initial 50-minute face-to-face interactive session in a private location. Participants are asked to extend time in bed by 1 hour and consistently maintain the extension on both weekends and weekdays. Bedtimes and waketimes will be assessed to ascertain which time is most modifiable for the participant's lifestyle and routine. There will be weekly follow-ups and in-person 3-week booster sessions. Sleep reports generated by the actigraphy will be shared with participants with brief action planning and goal setting to address progress towards goal achievement. A need to revise plans for future weeks will be the booster sessions' major goal.

Group Type: EXPERIMENTAL

Sleep Self-Management

Intervention Type: BEHAVIORAL

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).

Diabetes Self-Management Education

The Attention Control arm will receive Diabetes Self-Management Education at the initial consultation visit via in-person contact at T1. There will be weekly follow-ups and in-person 3-week sessions. A Diabetes Self-Management Tracking Form will be used to monitor the weekly acquisition of information and plans for the 6-week intervention and at the 3-month and 6-month data points.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1) Age range: from 18 to 26 years
• 2) Diagnosed with T1D for at least 6 months
• 3) No other major health problems (e.g., chronic medical condition or major psychiatric illness
• 4) Not currently participating in any intervention studies
• 5) Read/speak English
• 6) Have a most recent A1C or eA1C value ≥ 7%.

Exclusion Criteria

• 1) Previous OSA diagnosis/high-risk sleep apnea
• 2) Current pregnancy
• 3) Night shift workers
• 4) Habitually sleep > 7 hours on work or school days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Griggs, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K99NR018886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R00NR018886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20201829

Identifier Type: -

Identifier Source: org_study_id