Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM)

Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Sleep Extension; Behavioral: Routine

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Pediatric Endocrinology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Extension; All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer.	Behavioral: Sleep Extension; All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer
Sham Comparator: Routine; All youth in this condition are asked to follow the routine that their clinical team has established.	Behavioral: Routine; All youth in this condition are asked to follow the routines set by their clinical care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	A measure of glucose control	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Levels via continuous glucose monitor	Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor	1 and 3 months
Sleep Duration	Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Self-Management	Diabetes self-management and care activities will be assessed using the Diabetes Self-Management Profile for Flexible Regimes, Self- and Parent-proxy reports	1 and 3 months
Adherence to Diabetes Management	Adherence to diabetes management will be measured using the average daily manual glucose measurements from a personal glucometer (i.e. finger sticks)	1 and 3 months
Polysomnographic Sleep Architecture	Sleep architecture will be measured as percent time spent sleeping in the different stages of sleep (NREM 1, 2, 3, REM) using an in-home polysomnography system.	1 and 3 months
Quality of Life	Quality of Life will be measured using an aggregate of the Pediatric Quality of Life Inventory (PedsQL) Core 4.0 and Diabetes 3.2 modules.	1 and 3 months
Cortisol	Morning and evening Cortisol levels will be measured using a saliva collection device	1 and 3 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Michelle M Perfect, PhD, UA College of Education

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimated): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Management; Sleep; Youth
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RDK110528A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No