Type 1 DiabetesSLEEPT1DNCT02494375
Sleep and Type 1 Diabetes
A study testing Sleep and glucose assessments in people with Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sleep and glucose assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Glycemic Control in Type 1 Diabetic Children
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Sleep and glucose assessments
- Keywords
- Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese
- Medical subject headings
- Diabetes Mellitus, Type 1, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and glucose assessmentsOther
Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals
| Study group | Role | What they receive |
|---|---|---|
| Sleep and glucose assessement. | Experimental | Not described Receives: Other: Sleep and glucose assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between HbA1c and sleep characteristics
Measured: Month 3, Month 6 and Month 9
Secondary outcomes (3)
Glucose levels
3 daily pre- and post- meal glucose levels over a 3-day period
Measured: Month 3, Month 6 and Month 9
Daily salivary amylase variation (Enzyme Activity)
Assessment of salivary amylase levels
Measured: Month 3, Month 6 and Month 9
Body composition (BMI fat and lean mass percentage)
Assessment of body composition
Measured: Month 3, Month 6 and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start28 Jun 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494375
- Sponsor's protocol ID
- 69HCL15_0219
- Acronym
- SLEEPT1D
- Status last verified
- Oct 2020
- First submitted
- 3 Jul 2015
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Glycemic Control in Type 1 Diabetic Children
- ClinicalTrials.gov ID
- NCT02494375
- Acronym / sponsor ID
- SLEEPT1D / 69HCL15_0219
- Conditions
- Type 1 Diabetes
- Keywords
- Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Jun 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep and glucose assessement. | Experimental | Other: Sleep and glucose assessments |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep and glucose assessmentsSleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals | Other | Sleep and glucose assessement. |
Primary outcome
Association between HbA1c and sleep characteristics
Time frame: Month 3, Month 6 and Month 9
3 secondary outcomes
Glucose levels
Time frame: Month 3, Month 6 and Month 9
Daily salivary amylase variation (Enzyme Activity)
Time frame: Month 3, Month 6 and Month 9
Body composition (BMI fat and lean mass percentage)
Time frame: Month 3, Month 6 and Month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and glucose assessments in people with Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between HbA1c and sleep characteristics (time frame: Month 3, Month 6 and Month 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.