Family Routines Enhancing Adolescent Diabetes by Optimizing Management

NCT ID: NCT02974309

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2024-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sleep Extension

All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer.

Group Type: EXPERIMENTAL

Sleep Extension

Intervention Type: BEHAVIORAL

All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

Routine

All youth in this condition are asked to follow the routine that their clinical team has established.

Group Type: SHAM_COMPARATOR

Routine

Intervention Type: BEHAVIORAL

All youth in this condition are asked to follow the routines set by their clinical care team.

Interventions

Sleep Extension

All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

Intervention Type: BEHAVIORAL

Routine

All youth in this condition are asked to follow the routines set by their clinical care team.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle M Perfect, PhD

Role: PRINCIPAL_INVESTIGATOR

UA College of Education

Locations

Pediatric Endocrinology Clinic

Tucson, Arizona, United States

Countries

United States

Other Identifiers

RDK110528A

Identifier Type: -

Identifier Source: org_study_id