Clinical trial NCT02974309: Family Routines Enhancing Adolescent Diabetes by Optimizing Management
Official title: Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Youth
Diabetes Management
Sleep
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 115
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A three month randomized study to examine the potential benefits of sleep extension in tandem with clinical trial on diabetes management in youth with type 1 diabetes.

Detailed description: Type 1 Diabetes (T1DM) is one of the most common chronic medical conditions that occur in children. More than two-thirds of these young patients struggle to maintain optimal glycemic control. On a seemingly unrelated front, insufficient sleep has become a public health crisis as less than 30% of youth achieve the recommended number of hours on school nights. Prior research has supported that sleep disturbances contribute to elevated glucose levels and have a significant impact on memory, attention, and planning. These skills are essential to effective diabetes management. Despite the link between sleep and diabetes, no research has examined the benefits of an intervention to help these youth achieve a healthy sleep duration. To that end, our primary objective is to determine the effect of sleep extension on glycemic control and psychosocial functioning. Our secondary objective is to determine mediators and moderators of effect. The central hypothesis is that an increase in sleep duration will lower glucose levels and improve behavioral ratings (internalizing, externalizing, and classroom behaviors). Our primary study aims are to (1) Test if lengthening sleep improves glycemic control and psychosocial function in youth with T1DM; (2) Assess putative mechanisms for the effects of sleep extension on glucose and psychosocial function; and (3) Examine the possible moderating effect of pre-existing sleep parameters and sociodemographic variables that modify the impact of sleep extension. A secondary aim is exploratory to examine additional pre-selected mediators and moderators. In the proposed randomized study, up to 175 youth with T1DM will be assigned to a Sleep Extension or a supportive routines condition. The Sleep Extension lengthens youth's time in bed to allow for a healthy sleep duration on a consistent basis, whereas the supportive routines condition reinforces daytime and nighttime activities. We will test the impact of sleep extension on key indices of glycemic control (average glucose levels and % time hyperglycemia using continuous glucose monitors and HbA1C) as well as putative mechanisms of effect (e.g., heart rate variability and salivary cortisol levels) and participant characteristics that might mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and SES). Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes

Exclusion Criteria:

* neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
* not hospitalized within the previous month prior to enrollment

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Glucose Levels via continuous glucose monitor
timeFrame: 1 and 3 months
measure: Sleep Duration
timeFrame: 3 months
Other outcomes:
measure: Diabetes Self-Management
timeFrame: 1 and 3 months
measure: Adherence to Diabetes Management
timeFrame: 1 and 3 months
measure: Polysomnographic Sleep Architecture
timeFrame: 1 and 3 months
measure: Quality of Life
timeFrame: 1 and 3 months
measure: Cortisol
timeFrame: 1 and 3 months
Locations:
city: Tucson
country: United States
facility: Pediatric Endocrinology Clinic
state: Arizona
Study officials:
affiliation: UA College of Education
name: Michelle M Perfect, PhD
role: PRINCIPAL_INVESTIGATOR
References: