Sleep and Type 1 Diabetes (SLEEPT1D)

Civil Hospices of Lyon

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Other: Sleep and glucose assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT02494375

69HCL15_0219

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Sleep and glucose assessement.

Experimental group

Treatment:

Other: Sleep and glucose assessments