Sleep and Type 1 Diabetes

Sleep and Glycemic Control in Type 1 Diabetic Children

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02494375

Acronym

SLEEPT1D

Enrollment

Registered

2015-07-10

Start date

2015-06-28

Completion date

2022-12-31

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese

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.

Interventions

OTHERSleep and glucose assessments

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Association between HbA1c and sleep characteristics	Month 3, Month 6 and Month 9

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026