Sleep and Chronotype in Children With Type 1 Diabetes

NCT04978662 | Unknown

• 1 other identifier: 120S789
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes is the most common metabolic disorder in children and adolescents. Sleep is important for prognosis and several sleep parameters are related to metabolic control. However, limited number of studies in children and adolescents showed mixed results and recommendations about how to address sleep in the clinical care of diabetes in children are still lacking. There is a need to examine the potential role of sleep in developing preventive interventions for diabetes management in children and adolescents. The authors aimed to describe sleep/wake patterns ,sleep problems, and chronotype of children and adolescents with type 1 diabetes, and to assess the relation of sleep measures with metabolic control and treatment. The study has a prospective observational cross-sectional design. An estimated sample size is calculated as 83. Children diagnosed with type 1 diabetes between 6 to 18 years of age will be recruited from two pediatric endocrinology centers specialized in diabetes. Sleep/wake pattern will be assessed by actigraphy, and sleep diaries. Sleep disorder will be assessed by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale, and Chronotype Questionnaire will be used to determine the chronotype.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; sleep; adolescent; actigraphy; blood glucose

Outcome Measures

Primary Outcomes (3)

• sleep wake patterns measured by actigraphy

  sleep wake patterns

  baseline

• sleep disorder

  sleep disorder measured with the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale. The scale has an 8-item parent form, that could be filled up by parents or legal guardians of children aged between 6-17 years, and a 9-item self report form to be filled up by adolescents aged between 11-17 years. For each item, the caregiver is asked to rate the severity of symptoms related to sleep disorders that occurred within the past 7 days, she/he had observed in his/her child. The scale has a 5-point Likert type rating (1=never, 2=very little/rarely, 3=sometimes, 4=most of the time, 5=almost all the time). Total scores range between 8-40 and higher scores indicate presence of much more severe sleep-related problems.

  Baseline

• chronotype

  chronotype measured with Chronotype Questionnaire.Children's Chronotype Questionnaire (CCTQ) is a parent report, 27-item mixed format questionnaire measuring chronotype of children in multiple domains : the midsleep point on free days (MSF), a morningness/eveningness scale(M/E) score, and a five-point chronotype (CT) score.

  baseline

Secondary Outcomes (3)

• metabolic control

  baseline

• metabolic control

  baseline

• treatment

  baseline

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and adolescents diagnosed with Type 1 Diabetes aged between 6 to 18 years

You may qualify if:

• aged between 6 to 18 years
• use of continuous glucose monitoring system

You may not qualify if:

• acute medical condition that can impact sleep (diabetes keto acidosis, cold, influenza)
• diagnosed neurodevelopmental or behavioral condition like autism spectrum disorder or Attention Deficit/Hyperactivity Disorder
• diagnosed sleep disorder (Obstructive Sleep Apnea)
• Current use of medications that can impact sleep (diphenhydramine)

Sponsors & Collaborators

• Marmara University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 27, 2021
• Study Start: July 6, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)