Self-Management in Young Adults With Type 1 Diabetes

Not Applicable

Completed

Conditions: Type 1 Diabetes

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."

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Primary Outcome Measures

Name	Time	Method
Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	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).
Time in Range 70-180 mg/dL	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	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 \[trademark\]

Secondary Outcome Measures

Name	Time	Method
Diabetes Self-Management Questionnaire (15-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in diabetes self-management (higher scores indicate improvement)
10-Minute Psychomotor Vigilance Test on a PVT-192 Device	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in PVT scores (lower score indicates improvement)
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.	Change in executive function (lower scores indicate improvement)
PROMIS v1.0 (8-item General Distress-depression)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in general distress (lower scores indicate improvement)
Diabetes Distress Scale (17-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in diabetes distress (lower scores indicate improvement)
Diabetes Symptom Checklist Revised (34-item)	From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.	Change in diabetes physical symptoms (lower scores indicate improvement)

Trial Locations

Locations (1): University Hospitals of Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
University Hospitals of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States