Self-Management in Young Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Sleep Self-Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Behavioral: Sleep self-management
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Self-Management<br>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<br>* 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).<br>|
| No Intervention: Diabetes Self-Management Education<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Young Adult