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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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