Self-Management in Young Adults With Type 1 Diabetes

NCT04975230 | Completed Results DMC

• 3 other identifiers: STUDY20201829K99NR018886R00NR018886
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Young Adult

Outcome Measures

Primary Outcomes (2)

• Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)

  Average sleep duration as assessed as the average minutes per night participants spent asleep over the 7-14 days preceding each time point (Change in sleep duration (longer sleep duration indicates improvement).

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

• Time in Range 70-180 mg/dL

  Change in time in range 70-180mg/dL over the monitoring period (7-14 days). Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 \[trademark\]

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Secondary Outcomes (5)

• Diabetes Self-Management Questionnaire (27-item)

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

• Paper-based Trail Making Test Parts A and B (Executive Function)

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

• Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

• Diabetes Distress Scale (17-item)

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

• Diabetes Symptom Checklist Revised (34-item)

  From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

Other Outcomes (1)

• 10-Minute Psychomotor Vigilance Test on a PVT-192 Device

  From (T0) baseline through (T3) 90 days post intervention

Study Arms (2)

Sleep Self-Management

EXPERIMENTAL

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.

Behavioral: Sleep Self-Management

Diabetes Self-Management Education

NO INTERVENTION

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.

Interventions

Sleep Self-Management 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).

Sleep Self-Management

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Case Western Reserve University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, 44106-4904, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Stephanie Griggs
• Organization: Case Western Reserve University

stephanie.griggs2@emory.edu

404-544-9915

Study Officials

• Stephanie Griggs, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both conditions will receive time-balanced sessions with the study team. Participants will not be told whether in the experimental condition or the condition delivering usual care until after the completion of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavioral: Sleep self-management

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 23, 2021
• Study Start: April 29, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 1, 2023
• Last Updated: January 12, 2026
• Results First Posted: July 31, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)