Sleep and Chronotype in Children With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Determination of Sleep Disorder and Chronotype in Children and Adolescents With Type 1 Diabetes; Observation of the Impact on Glycemic Control and Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04978662
• Other study ID #: 120S789
• Status: Enrolling by invitation
• Start date: July 6, 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 preventive interventions.

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 wake patterns will be assessed by Philips Respironics Mini-Mitter Actiwatch-2 for at least 3 days at home environment and sleep diaries within 5-minute intervals will be filled out by parents. Actigraphy is a validated wristwatch-like device that distinguishes sleep from wakefulness based on accelerometer measured movement.

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.

For metabolic control, targeted standard values will be used for continuous glucose measurement. (Target daily blood glucose ranges 70-180 mg/dl, <4% <70 mg/dl, <1% <54 mg/dl, <25% >180 mg/dl, <5% rate >250 mg/dl). The latest Hemoglobin A1c level will also be evaluated.

A questionnaire developed by the investigators including sociodemographic characteristics, and diabetes related information will be gathered from the patient records.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• aged between 6 to 18 years

• use of continuous glucose monitoring system

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep wake patterns measured by actigraphy	sleep wake patterns	baseline
Primary	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
Primary	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	metabolic control	metabolic control measured by number of hypo and hyperglycemic episodes over the past month	baseline
Secondary	metabolic control	metabolic control measured by the most recent hemoglobin A1c	baseline
Secondary	treatment	treatment measured by insulin dose per kilogram	baseline