Sleep and Type 1 Diabetes

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Other: Sleep and glucose assessments

• Registration Number: NCT02494375
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06-28
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France.

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Exclusion Criteria

• Refusal of consent of the parents or the child or the adolescent
• Pregnancy
• Concomitant pathology that severly impacts sleep
• Implanted electrical stimulation device
• Diagnosis of type 1 diabetes <1 year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep and glucose assessement.	Sleep and glucose assessments	-

Primary Outcome Measures

Name	Time	Method
Association between HbA1c and sleep characteristics	Month 3, Month 6 and Month 9

Secondary Outcome Measures

Name	Time	Method
Body composition (BMI fat and lean mass percentage)	Month 3, Month 6 and Month 9	Assessment of body composition
Daily salivary amylase variation (Enzyme Activity)	Month 3, Month 6 and Month 9	Assessment of salivary amylase levels
Glucose levels	Month 3, Month 6 and Month 9	3 daily pre- and post- meal glucose levels over a 3-day period

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France