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Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02974309
Recruitment Status : Unknown
Verified November 2016 by University of Arizona.
Recruitment status was:  Recruiting
First Posted : November 28, 2016
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Sleep Extension Behavioral: Routine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months ]
    A measure of glucose control

Secondary Outcome Measures :
  1. Glucose Levels via continuous glucose monitor [ Time Frame: 1 and 3 months ]
    Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor

  2. Sleep Duration [ Time Frame: 3 months ]
    Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.

Other Outcome Measures:
  1. Diabetes Self-Management [ Time Frame: 1 and 3 months ]
    Diabetes self-management and care activities will be assessed using the Diabetes Self-Management Profile for Flexible Regimes, Self- and Parent-proxy reports

  2. Adherence to Diabetes Management [ Time Frame: 1 and 3 months ]
    Adherence to diabetes management will be measured using the average daily manual glucose measurements from a personal glucometer (i.e. finger sticks)

  3. Polysomnographic Sleep Architecture [ Time Frame: 1 and 3 months ]
    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.

  4. Quality of Life [ Time Frame: 1 and 3 months ]
    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.

  5. Cortisol [ Time Frame: 1 and 3 months ]
    Morning and evening Cortisol levels will be measured using a saliva collection device

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02974309

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Contact: Michelle M Perfect, PhD 5206261128

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United States, Arizona
Angel Wing Clinic for Diabetes Recruiting
Tucson, Arizona, United States, 85719
Principal Investigator: Michelle M Perfect, Ph.D.         
Sub-Investigator: Mark Wheeler, MD         
Sponsors and Collaborators
University of Arizona
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Principal Investigator: Michelle M Perfect, PhD UA College of Education
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Responsible Party: University of Arizona Identifier: NCT02974309    
Other Study ID Numbers: RDK110528A
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request.

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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
Keywords provided by University of Arizona:
Diabetes Management
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases