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

NCT02908555 | Completed

• 1 other identifier: 1507016174
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Explore the relationship of glucose excursions on sleep characteristics and executive functioning.

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes; adolescents; sleep

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Hemoglobin A1C

  baseline

Secondary Outcomes (1)

• Executive functioning

  baseline

Study Arms (1)

no intervention

Descriptive study without groups

Other: No intervention

Interventions

No intervention OTHER

This is a descriptive study with no intervention

no intervention

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

40 youth with type 1 diabetes, age 10-16 years, diagnosed for at least 6 months

You may qualify if:

• diagnosed for at least 6 months

You may not qualify if:

• able to comply with protocol

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Nursing

West Haven, Connecticut, 06516-0972, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Margaret Grey, DrPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2016
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after data collection is complete
• Access Criteria: By request to principal investigator

Locations

US (1)