N/A
N=39
Sleep Promotion to Improve Diabetes Management in Adolescents With T1D
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02786953 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Sleep Quality: Baseline — 4.3; 4.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Promotion (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality: Baseline |
4.3; 4.5 | — |
| PRIMARY Sleep Quality 3 Months |
3.9; 4.8 | — |
| PRIMARY Glycemic Control (HbA1c) Baseline |
9.4; 9.1 | — |
| PRIMARY Glycemic Control (HbA1c) 3 or 6 Months |
9.2; 9.2 | — |
| PRIMARY Sleep Duration: Baseline |
6.85; 6.69 | — |
| PRIMARY Sleep Duration: 3 Months |
7.02; 6.37 | — |
| SECONDARY Quality of Life (PedsQL) |
70.3; 74.5; 72.5; 75.4 | — |
| SECONDARY Adherence (Self Care Inventory) Parent |
3.7; 3.8; 3.8; 3.7 | — |
| SECONDARY Adherence (Self Care Inventory) Teen |
3.9; 3.7; 3.8; 3.9 | — |
Summary
Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and suboptimal glycemic control, and novel approaches are needed to improve outcomes in this high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8 hours/night), and sleep disturbance has been significantly associated with poorer adherence and predicted greater problems with quality of life and worse glycemic control. Yet, no interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention to meet the needs of adolescents with T1D by conducting interviews with to identify the barriers and facilitators to adequate sleep specific to this population. The sleep-promoting intervention will be developed and tested, building on successful sleep interventions in other populations, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, while addressing the needs unique to adolescents with T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a physiological and behavioral impact on diabetes outcomes. Given the strong associations between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep restriction studies indicating the impact of insufficient sleep on insulin sensitivity, behavior, and mood, there is reason to believe that a sleep-promoting intervention has the potential to improve outcomes in adolescents with T1D indirectly by improving adherence and directly through its effect on metabolic function. Therefore, the proposed study offers a novel approach to improve adherence, quality of life, and glycemic control in adolescents with T1D.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 1 diabetes for at least 12 months
- Speak and read English
- Report Insufficient sleep (< 8 hours/night most school nights)
Exclusion Criteria
- Other major health problems or sleep disorders (other than insomnia)
Data sourced from ClinicalTrials.gov (NCT02786953). 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.