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Sleep and Chronotype in Children With Type 1 Diabetes

20. juli 2021 opdateret af: Perran Boran, Marmara University

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

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.

Studieoversigt

Status

Tilmelding efter invitation

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

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Studiesteder

      • Istanbul, Kalkun
        • Marmara University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
sleep wake patterns measured by actigraphy
Tidsramme: baseline
sleep wake patterns
baseline
sleep disorder
Tidsramme: Baseline
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
Tidsramme: baseline
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
metabolic control
Tidsramme: baseline
metabolic control measured by number of hypo and hyperglycemic episodes over the past month
baseline
metabolic control
Tidsramme: baseline
metabolic control measured by the most recent hemoglobin A1c
baseline
treatment
Tidsramme: baseline
treatment measured by insulin dose per kilogram
baseline

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. juli 2021

Primær færdiggørelse (Forventet)

1. oktober 2021

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

6. juli 2021

Først indsendt, der opfyldte QC-kriterier

20. juli 2021

Først opslået (Faktiske)

27. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

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Kliniske forsøg med Diabetes mellitus, type 1

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