Family Routines Enhancing Adolescent Diabetes by Optimizing Management

Type 1 Diabetes Clinical Trial

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Official title:

Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974309
• Other study ID #: RDK110528A
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: University of Arizona
• Contact: Michelle M Perfect, PhD
• Phone: 5206261128
• Email: mperfect[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Endocrinology Clinic	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Cortisol	Morning and evening Cortisol levels will be measured using a saliva collection device	1 and 3 months
Primary	HbA1c	A measure of glucose control	3 months
Secondary	Glucose Levels via continuous glucose monitor	Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor	1 and 3 months
Secondary	Sleep Duration	Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.	3 months