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Completed

NCT Number: NCT04975230

Self-Management in Young Adults With Type 1 Diabetes

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.

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Key information

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, 44106-4904, United States

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

    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).

  2. Time in Range 70-180 mg/dL

    Time frame: 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 outcomes

  1. Diabetes Self-Management Questionnaire (27-item)

    Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

    Change in Diabetes Self-Management Questionnaire (DSMQ) scores. The DSMQ is a 27-item scale assessing behaviors and activities related to diabetes self-management. Each item is scored on a 4-point Likert scale from 0 (does not apply to me) to 3 (applies to me very much), and items scores are summed/transformed to a total score (range 0 to 10) reflecting overall diabetes self-management, with higher scores indicating better self-management skills (better outcome). This outcome represents the change in scores from baseline to post intervention. Diabetes self-management is an ongoing process where individuals actively manage their condition to maintain optimal blood sugar levels, prevent complications, and improve their overall quality of life.

  2. Paper-based Trail Making Test Parts A and B (Executive Function)

    Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

    Change in executive function (lower scores indicate improvement). The Trail Making Test (TMT) consists of two parts, A and B, which assess performance/cognitive function as the time taken to complete each part in seconds. In Part A, numbered circles (1-25) are connected in ascending order as quickly as possible. In Part B, circles are connected in ascending order with the added task of alternating between numbers and letters (1-A-2-B, etc.). Both parts are summed and scored based on the time taken to complete the task, with higher scores (longer time) indicating greater cognitive impairment.

  3. Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form

    Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

    Change in general distress (lower scores indicate improvement). The Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form is an 8-item instrument to assess depression symptoms. Each item is scored on a 5-point Likert scale from 1 (Never) to 5 (Always). Total raw scores range from 8-40 with higher scores indicating greater depressive symptoms.

  4. Diabetes Distress Scale (17-item)

    Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

    Change in diabetes distress (lower scores indicate improvement). The Diabetes Distress Scale (DDS) is a 17-item tool to measure emotional distress as experienced by individuals living with diabetes. Each item is scored on a 6-point Likert scale from 1 (Not a Problem) to 6 (A Very Serious Problem) with a total score range of 17-102

  5. Diabetes Symptom Checklist Revised (34-item)

    Time frame: From (T0) baseline through 12-week intervention period (T2) captured immediately post intervention period.

    Change in diabetes physical symptoms (lower scores indicate improvement). The Diabetes Symptom Checklist Revised (DSC-R) is a 34-item checklist to assess type 2 diabetes symptom burden using a 5-point Likert scale ranging from 0 (Not at all) to 5 (Extremely) with a total score range of 0-170 where higher scores indicate increased symptom burden

Other outcomes

  1. 10-Minute Psychomotor Vigilance Test on a PVT-192 Device

    Time frame: From (T0) baseline through (T3) 90 days post intervention

    Change in Psychomotor Vigilance Test (PVT) score. The PVT as administered by the PVT-192 device (Ambulatory Monitoring) measures reaction time to assess alertness as an effect of sleep deprivation. Reactions are measure in time by seconds, where lower time scores in seconds indicating greater levels of alertness.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: SLEEPT1D

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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