Back to resultsSleep and Type 1 Diabetes (SLEEPT1D)
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep and glucose assessments
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes focused on measuring Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep and glucose assessement.
Arm Description
Outcomes
Primary Outcome Measures
Association between HbA1c and sleep characteristics
Secondary Outcome Measures
Glucose levels
3 daily pre- and post- meal glucose levels over a 3-day period
Daily salivary amylase variation (Enzyme Activity)
Assessment of salivary amylase levels
Body composition (BMI fat and lean mass percentage)
Assessment of body composition
Full Information
NCT ID
NCT02494375
First Posted
July 3, 2015
Last Updated
October 1, 2020
Sponsor
Hospices Civils de Lyon
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02494375
Brief Title
Sleep and Type 1 Diabetes
Acronym
SLEEPT1D
Official Title
Sleep and Glycemic Control in Type 1 Diabetic Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep and glucose assessement.
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Sleep and glucose assessments
Intervention Description
Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals
Primary Outcome Measure Information:
Title
Association between HbA1c and sleep characteristics
Time Frame
Month 3, Month 6 and Month 9
Secondary Outcome Measure Information:
Title
Glucose levels
Description
3 daily pre- and post- meal glucose levels over a 3-day period
Time Frame
Month 3, Month 6 and Month 9
Title
Daily salivary amylase variation (Enzyme Activity)
Description
Assessment of salivary amylase levels
Time Frame
Month 3, Month 6 and Month 9
Title
Body composition (BMI fat and lean mass percentage)
Description
Assessment of body composition
Time Frame
Month 3, Month 6 and Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
12. IPD Sharing Statement
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Sleep and Type 1 Diabetes
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