Self-Management in Young Adults With Type 1 Diabetes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT04975230
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 26 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Apr 29, 2022
Status verified
Jan 2026
Primary completion
Oct 31, 2023
Completion
Nov 1, 2023

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: Diabetes Self-Management Education
    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.

Primary Outcome Measure

Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus) [ Time Frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals of Cleveland Medical CenterClevelandOhio44106-4904-

Find similar trials in Cleveland, OH

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University Hospitals of Cleveland Medical Center· Cleveland, OH

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