Clinical trial NCT04975230: Self-Management in Young Adults With Type 1 Diabetes
Official title: Sleep, Glycemia, and Self-Management in Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Young Adult
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Institutes of Health (NIH)
First posted: 2021-07-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Sleep self-management
Primary purpose: SUPPORTIVE_CARE

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."

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.

Primary outcomes:
measure: Non-dominant wrist-worn actigraph to be worn 24/7 (Spectrum Plus)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: Continuous Glucose Monitor (CGM) data downloaded directly from each participant's existing or provided blinded Dexcom G6 [trademark]
timeFrame: From (T0) baseline through (T3) 90 days post intervention
Secondary outcomes:
measure: Diabetes Self-Management Questionnaire (15-item)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: 10-Minute Psychomotor Vigilance Test on a PVT-192 device
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: Paper-based Trail Making Test parts A and B (Executive Function)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: PROMIS v1.0 (8-item general distress-depression)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: Diabetes Distress Scale (17-item)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
measure: Diabetes Symptom Checklist Revised (34-item)
timeFrame: From (T0) baseline through (T3) 90 days post intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Stephanie Griggs, PhD
role: PRINCIPAL_INVESTIGATOR
References: