N/A
N=39
Self-Management in Young Adults With Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04975230 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus) — 18; -25.8 min per night — p=0.0227
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Self-Management (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-dominant Wrist-worn Actigraph to be Worn 24/7 (Spectrum Plus) |
18; -25.8 | 0.0227 sig |
| PRIMARY Time in Range 70-180 mg/dL |
0.82; -0.35 | — |
| SECONDARY Diabetes Self-Management Questionnaire (27-item) |
0; 0.44 | — |
| SECONDARY Paper-based Trail Making Test Parts A and B (Executive Function) |
-2.93; -0.92 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form |
1.17; -0.34 | — |
| SECONDARY Diabetes Distress Scale (17-item) |
-3.01; -2.22 | — |
| SECONDARY Diabetes Symptom Checklist Revised (34-item) |
0; -0.13 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04975230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.