Type 1 Diabetes Clinical Trial
— FREADOMOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pediatric Endocrinology Clinic | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
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 |
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