Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes

NCT06318611 | Completed

• 1 other identifier: 09.2022.575
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D. The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168. The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters.

Conditions

Type1diabetes; Sleep; Chronotype

Keywords

type 1 diabetes; chronotype; continuous glucose monitoring; glycemic variability; sleep health; sleep

Outcome Measures

Primary Outcomes (2)

• Sleep health composite

  The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances.

  Prospective, up to 24 weeks

• Chronotype

  Chronotype was evaluated by the Children's Chronotype Questionnaire. The Childhood Chronotype Questionnaire was used to evaluate the chronotype in children. This 27-item questionnaire was developed for Turkish children in the light of the Munich Chronotype Questionnaire and the Mornings-Evenings Questionnaire. The chronotypes were classified as morning, intermediate and evening types, corresponding scores of ≤23, 24-32 and ≥33. The child form of the Childhood Chronotype Questionnaire was completed by the parent and the adolescent form was completed by the adolescent.

  Prospective, up to 24 weeks

Secondary Outcomes (2)

• Glycemic variability

  Prospective, up to 24 weeks

• Glycemic control

  Prospective, up to 24 weeks

Study Arms (2)

Case group

Children and adolescents diagnosed with type 1 diabetes aged between 6 to 18 years

Other: sleep, chronotype

Control group

Children and adolescents without type 1 diabetes between the ages of 6 and 18.

Other: sleep, chronotype

Interventions

sleep, chronotype OTHER

Our objectives were to compare sleep health composite dimensions, and chronotype in children and adolescents with and without T1D, and to explore relationship between sleep and glycemic variability in T1D.

Case group; Control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and adolescents diagnosed with and without type 1 diabetes aged between 6 to 18 years

You may qualify if:

• Aged between 6 to 18 years
• Use of continuous glucose monitor system

You may not qualify if:

• Acute medical condition that can impact sleep (diabetic ketoacidosis, cold, influenza)
• Diagnosed neurodevelopmental or behavioral conditions 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

• Koç University: lead
• Marmara University: collaborator

Study Sites (1)

Necla İpar

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• Ipar N, Boran P, Baris HE, Us MC, Aygun B, Haliloglu B, Baygul A, Mutlu GY, Bereket A, Hatun S. The sleep health composite and chronotype among children and adolescents with type 1 diabetes compared to case-control peers without diabetes. J Clin Sleep Med. 2025 May 1;21(5):825-834. doi: 10.5664/jcsm.11558.

  PMID: 39789979 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sleep; Chronotype

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Circadian Rhythm; Periodicity; Chronobiology Phenomena; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 19, 2024
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)