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NCT02494375 Clinical Trial

Sleep and Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— SLEEPT1D  

Official title:
Sleep and Glycemic Control in Type 1 Diabetic Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02494375
Other study ID # 69HCL15_0219
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 28, 2015
Est. completion date December 2022

Study information
Verified date October 2020
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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.

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sleep and glucose assessments
Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (2)
Lead Sponsor Collaborator
Hospices Civils de Lyon Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association between HbA1c and sleep characteristics Month 3, Month 6 and Month 9
Secondary Glucose levels 3 daily pre- and post- meal glucose levels over a 3-day period Month 3, Month 6 and Month 9
Secondary Daily salivary amylase variation (Enzyme Activity) Assessment of salivary amylase levels Month 3, Month 6 and Month 9
Secondary Body composition (BMI fat and lean mass percentage) Assessment of body composition Month 3, Month 6 and Month 9
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