Self-Management in Young Adults With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Sleep Self-Management

• Registration Number: NCT04975230
• Lead Sponsor: Case Western Reserve University

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."

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-23
• Study Start: 2022-04-29
• Primary Completion: 2023-11-01
• Study Completion: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Self-Management	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.

Primary Outcome Measures

Name	Time	Method
Non-dominant wrist-worn actigraph to be worn 24/7 (Spectrum Plus)	From (T0) baseline through (T3) 90 days post intervention	Change in sleep duration (longer sleep duration indicates improvement)
Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 [trademark]	From (T0) baseline through (T3) 90 days post intervention	Change in time in range and glucose variability (More time in range and less glucose variability indicates improvement)

Secondary Outcome Measures

Name	Time	Method
Diabetes Self-Management Questionnaire (15-item)	From (T0) baseline through (T3) 90 days post intervention	Change in diabetes self-management (higher scores indicate improvement)
10-Minute Psychomotor Vigilance Test on a PVT-192 device	From (T0) baseline through (T3) 90 days post intervention	Change in PVT scores (lower score indicates improvement)
Paper-based Trail Making Test parts A and B (Executive Function)	From (T0) baseline through (T3) 90 days post intervention	Change in executive function (lower scores indicate improvement)
PROMIS v1.0 (8-item general distress-depression)	From (T0) baseline through (T3) 90 days post intervention	Change in general distress (lower scores indicate improvement)
Diabetes Distress Scale (17-item)	From (T0) baseline through (T3) 90 days post intervention	Change in diabetes distress (lower scores indicate improvement)
Diabetes Symptom Checklist Revised (34-item)	From (T0) baseline through (T3) 90 days post intervention	Change in diabetes physical symptoms (lower scores indicate improvement)

Trial Locations

Locations (1)

University Hospitals of Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States