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Trial record 34 of 2360 for:    "Diabetes Mellitus, Insulin-Dependent"

Sleep, Coping and Executive Functioning in Youth With Type 1 Diabetes (SleepT1D)

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ClinicalTrials.gov Identifier: NCT02908555
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

The purpose of this exploratory study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations among sleep characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative component will be used. Results from this pilot study will be used to provide the effect sizes needed for a larger-scale descriptive study and to establish the need for a possible sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent with ongoing research focused on developing preventive, behavioral interventions for youth with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and psychological (i.e., quality of life) outcomes. Sleep promotion may become an important component of these interventions. Thus, the following specific aims will be addressed:

  1. Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
  2. Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.
  3. Explore the relationship of glucose excursions on sleep characteristics and executive functioning.

3. Conduct a qualitative study using narrative analysis with adolescents to identify perceived barriers, facilitators, and consequences associated with insufficient sleep in adolescents with type 1 diabetes.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Other: No intervention

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Sleep, Coping, and Executive Functioning in Youth With Type 1 Diabetes
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
no intervention
Descriptive study without groups
Other: No intervention
This is a descriptive study with no intervention




Primary Outcome Measures :
  1. Glycemic control [ Time Frame: baseline ]
    Hemoglobin A1C


Secondary Outcome Measures :
  1. Executive functioning [ Time Frame: baseline ]
    Trail Making Test Part B



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 youth with type 1 diabetes, age 10-16 years, diagnosed for at least 6 months
Criteria

Inclusion Criteria:

  • diagnosed for at least 6 months

Exclusion Criteria:

  • able to comply with protocol

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 ClinicalTrials.gov identifier (NCT number): NCT02908555


Locations
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United States, Connecticut
Yale School of Nursing
West Haven, Connecticut, United States, 06516-0972
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Margaret Grey, DrPH Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02908555     History of Changes
Other Study ID Numbers: 1507016174
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared once analyses are final.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1 year after data collection is complete
Access Criteria: By request to principal investigator

Keywords provided by Yale University:
type 1 diabetes
adolescents
sleep

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