Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: Sleep Extension Behavioral: Routine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
All youth in this condition are asked to follow the routines set by their clinical care team.
- HbA1c [ Time Frame: 3 months ]A measure of glucose control
- 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
- Sleep Duration [ Time Frame: 3 months ]Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.
- 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
- 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)
- 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.
- 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.
- Cortisol [ Time Frame: 1 and 3 months ]Morning and evening Cortisol levels will be measured using a saliva collection device
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 ClinicalTrials.gov identifier (NCT number): NCT02974309
|Contact: Michelle M Perfect, PhDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Michelle M Perfect, PhD||UA College of Education|