Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

NCT02786953 | Completed Results DMC

• 1 other identifier: 151271
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and suboptimal glycemic control, and novel approaches are needed to improve outcomes in this high-risk population. The majority of adolescents obtain insufficient sleep (defined as \<8 hours/night), and sleep disturbance has been significantly associated with poorer adherence and predicted greater problems with quality of life and worse glycemic control. Yet, no interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention to meet the needs of adolescents with T1D by conducting interviews with to identify the barriers and facilitators to adequate sleep specific to this population. The sleep-promoting intervention will be developed and tested, building on successful sleep interventions in other populations, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, while addressing the needs unique to adolescents with T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a physiological and behavioral impact on diabetes outcomes. Given the strong associations between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep restriction studies indicating the impact of insufficient sleep on insulin sensitivity, behavior, and mood, there is reason to believe that a sleep-promoting intervention has the potential to improve outcomes in adolescents with T1D indirectly by improving adherence and directly through its effect on metabolic function. Therefore, the proposed study offers a novel approach to improve adherence, quality of life, and glycemic control in adolescents with T1D.

Conditions

Diabetes Mellitus, Type 1

Keywords

Sleep; Adherence; Diabetes Management; Adolescent

Outcome Measures

Primary Outcomes (6)

• Sleep Quality: Baseline

  Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  baseline

• Sleep Quality 3 Months

  Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  3 months

• Glycemic Control (HbA1c) Baseline

  HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

  Baseline

• Glycemic Control (HbA1c) 3 or 6 Months

  HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

  3 months or 6 months

• Sleep Duration: Baseline

  Sleep duration will be measured with actigraphy (total sleep time)

  baseline

• Sleep Duration: 3 Months

  Sleep duration will be measured with actigraphy (total sleep time)

  3 months

Secondary Outcomes (3)

• Quality of Life (PedsQL)

  Baseline and 3 months

• Adherence (Self Care Inventory) Parent

  Baseline and 3 months

• Adherence (Self Care Inventory) Teen

  Baseline and 3 months

Study Arms (2)

Sleep Promotion

EXPERIMENTAL

Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.

Behavioral: Sleep Promotion

Usual Care

NO INTERVENTION

Usual Care

Interventions

Sleep Promotion BEHAVIORAL

Behavioral intervention to improve sleep quality and duration.

Sleep Promotion

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with type 1 diabetes for at least 12 months
• Speak and read English
• Report Insufficient sleep (\< 8 hours/night most school nights)

You may not qualify if:

• Other major health problems or sleep disorders (other than insomnia)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, 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

Limitations and Caveats

pilot study with small sample size

Results Point of Contact

• Title: Sarah S Jaser
• Organization: Vanderbilt University Medical Center

sarah.jaser@vumc.org

6153436775

Study Officials

• Sarah S Jaser, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 1, 2016
• Study Start: October 19, 2017
• Primary Completion: October 23, 2018
• Study Completion: February 5, 2019
• Last Updated: January 18, 2020
• Results First Posted: October 18, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)